Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care
Diagnosis and Treatment of Adults with Osteoporotic Vertebral Fractures
Recommendations:
Interventional Treatment
Interventional Treatment Question 1: Do steroid and/or anesthetic injections improve outcomes in patients with acute osteoporotic vertebral compression fractures?
There is insufficient evidence to make a recommendation for or against facet blocks in addition to percutaneous vertebroplasty compared to percutaneous vertebroplasty alone in adults with osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a retrospective comparative study, Cheng et al1 compared the treatment effects of percutaneous vertebroplasty and intra-articular facet blocking combined therapy versus percutaneous vertebroplasty alone on OVCFs. The authors concluded that “PVP and FB combined therapy could provide better pain relief than PVP alone in short term after operation in patients with OVCFs associated back pains.” This paper provides Level III evidence that facet blocks in addition to PVP can offer more pain improvement up to 3 months after the procedure as compared to PVP alone. References: 1. Cheng Y, Wu X, Shi J, Jiang H. Percutaneous Vertebroplasty and Facet Blocking for Treating Back Pain Caused by Osteoporotic Vertebral Compression Fracture. Pain Res Manag. 2020;2020:5825317
There is insufficient evidence to make a recommendation for or against facet blocks with local anesthetics and corticosteroids in adults with osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a prospective randomized control trial study, Wang et al1 examined the clinical and radiological outcomes of patients who underwent PVP treatment versus those who went through facet blocking (FB) for severe pain due to OVCFs. The authors concluded that this paper provides Level I evidence that “PVP produced better pain relief than FB in the short term (B1 week). However, the difference in pain relief between these two techniques was insignificant in the long term (follow-up between 1 month and 12 months).” This paper provides Level I evidence that percutaneous vertebroplasty is superior to facet block in short term pain relief on functional outcome up to 1-month postprocedure but no long-term difference. References: 1. Wang B, Guo H, Yuan L, Huang D, Zhang H, Hao D. A prospective randomized controlled study comparing the pain relief in patients with osteoporotic vertebral compression fractures with the use of vertebroplasty or facet blocking. Eur Spine J. 2016;25(11):3486-3494. doi:10.1007/s00586-016-4425-4
FLASK Future Directions for Research
The work group recommends high-quality studies evaluating the role of facet blocks in patients with acute osteoporotic vertebral compression fractures.
Interventional Treatment Question 2: What is the risk of treating multiple vertebral levels at one time, for patients with multilevel osteoporotic vertebral compression fractures?
Vertebral augmentation may be considered as a safe and effective option to treat multiple vertebral fractures during one procedure time with a low risk in adults with osteoporotic vertebral compression fractures.
Grade of Recommendation: C
In a prospective randomized control trial study, Chen et al1 investigated the safety and long-term effects of unilateral or bilateral balloon kyphoplasty for treating multilevel symptomatic vertebral compression fractures. Complications reported included: cement extravasation in 6/49 patients (12.2%), all of whom were reported as asymptomatic, cement embolization to pulmonary artery (N=1/49), and subsequent fractures (N=3/49). The authors concluded that “both unilateral and bilateral kyphoplasty markedly improve symptom-related clinical effects of multilevel vertebral compression fractures and result in significant vertebral height restoration and kyphosis correction that remains stable for at least 2 years after treatment.” The work group downgraded this potential Level I paper due to low sample size and lack of subgroup analysis. This paper provides Level II evidence that multiple OVCF can be treated simultaneously with a low risk of significant adverse events. There was no significant difference in clinical or radiological effects in patients undergoing multilevel, unilateral or bilateral kyphoplasty for OVCF. In a retrospective case series study, Ren et al2 studied the risk factors of new symptomatic vertebral compression fractures after percutaneous vertebroplasty. The authors concluded that “the incidence of new symptomatic VCFs after PVP was higher in osteoporotic patients with initial multiple-level fractures.” This paper provides Level IV evidence that the incidence of new symptomatic OVCF after PVP was higher in osteoporotic patients with initial multiple-level fractures. The number of initial symptomatic fractures was an important risk factor for new vertebral compression fractures. However, whether the risk of onset of new fractures was a function of the number of levels involved initially or specifically a result of the augmentation of these multiple levels fractures is unclear. No intraoperative or postoperative cardiovascular or cerebrovascular events or pulmonary embolism events were reported in patients with multiple-level fractures. In a retrospective case series study, Zhai et al3 evaluated the clinical effect of PKP, and the safeguards against vertebral refractures in the treatment of OVCF. 18% had cement leakage, the most frequent locations being the paravertebral vessels and paraspinal soft tissues, with low incidence of leakage into the spinal canal. This was not associated with any clinical symptomatology. There was a slightly higher rate of about 14.8% adjacent level fractures associated with multilevel OVCF as compared to 3.6% in single-level OVCF. Mean duration of subsequent fractures was about 12 months (range 3 – 33 months) after the primary procedure. The authors concluded that “percutaneous kyphoplasty is safe and effective to treat multiple osteoporotic vertebral compression fractures. However, the risk of new adjacent vertebral fractures in the multiple osteoporotic vertebral compression fractures is higher than that in the single osteoporotic vertebral compression fracture. Timely and proper treatment can reduce refractures.” This paper provides Level IV evidence that in patients with OVCF percutaneous kyphoplasty is safe and effective for multiple levels. In a retrospective case series study, Zidan et al4 evaluated the safety and adequacy of multilevel PVP in the management of osteoporotic vertebral fractures. Complications reported included asymptomatic cement leak-paraspinal/disc related and one pulmonary embolism treated with anticoagulation. The authors concluded that “multilevel PV for the treatment of osteoporotic fractures is a safe and successful procedure that can significantly reduce pain and improve patient’s condition without a significant morbidity. It is considered a cost-effective procedure allowing a rapid restoration of patient mobility.” This paper provides Level IV evidence that multilevel percutaneous vertebroplasty for the treatment of osteoporotic fractures is a safe and successful procedure that can significantly reduce pain and improve patient’s condition without a significant morbidity. A total of patients 10% developed new fracture requiring second VP. One patient developed symptomatic pulmonary embolism with satisfactory recovery.
References 1. Chen L, Yang H, Tang T. Unilateral versus bilateral balloon kyphoplasty for multilevel osteoporotic vertebral compression fractures: a prospective study. Spine (Phila Pa 1976). 2011;36(7):534-540. doi:10.1097/BRS.0b013e3181f99d70 2. Ren HL, Jiang JM, Chen JT, Wang JX. Risk factors of new symptomatic vertebral compression fractures in osteoporotic patients undergone percutaneous vertebroplasty. Eur Spine J. 2015;24(4):750-758. doi:10.1007/s00586-015-3786-4 3. Zhai W, Jia Y, Wang J, et al. The clinical effect of percutaneous kyphoplasty for the treatment of multiple osteoporotic vertebral compression fractures and the prevention of new vertebral fractures. Int J Clin Exp Med. 2015;8(8):13473-13481. 4. Zidan I, Fayed AA, Elwany A. Multilevel Percutaneous Vertebroplasty (More than Three Levels) in the Management of Osteoporotic Fractures. J Korean Neurosurg Soc. 2018;61(6):700-706. doi:10.3340/jkns.2017.0253
FLASK Future Directions for Research
The work group recommends high-quality studies evaluating the treatment of multiple levels in more than one setting in adults with osteoporotic vertebral compression fractures.
Interventional Treatment Question 3: Does vertebral augmentation improve outcomes in patients with acute osteoporotic vertebral compression fractures compared to medical therapy?
Vertebral augmentation is recommended as it provides rapid and sustained clinically and statistically significant improvement in pain and function in adults with acute osteoporotic vertebral compression fractures.
Grade of Recommendation: A
Many Level I & II studies found pain and function relief up to a year. Additionally, some Level III studies evaluated different time ranges. Therefore, a specific time period is not included in the recommendation itself. In a prospective randomized control trial study, Farrokhi et al1 compared the effectiveness of PVP in relation to optimal medical treatment (OMT) by evaluating pain and quality of life in patients with vertebral compression fractures. The authors concluded “the PVP group had statistically significant improvements in visual analog scale and QOL scores maintained over 24 months, improved VBH maintained over 36 months, and fewer adjacent-level fractures compared with the OMT group.” This paper provides Level I evidence that compared to optimal medical treatment, PVP had statistically significant improvements in pain relief and QOL that was maintained for 2 years with sustained improvements in vertebral body height corrections in spine deformity after 3 years, and had fewer adjacent-level fractures. In a prospective randomized control trial study, Klazen et al2 aimed to clarify whether vertebroplasty has additional value in comparison to optimum pain treatment in patients with acute vertebral fractures. The authors concluded “in a selected subgroup of patients with acute osteoporotic vertebral fractures and persistent pain, vertebroplasty is effective and safe. Pain relief after the procedure is immediate, sustained for 1 year, and is significantly better than that achieved with medical management and at acceptable costs, on the assumption of a societal willingness to pay €30 000 per QALY gained.” This paper provides Level I evidence that VA provided superior pain relief out to one year in comparison to medical management. The study was funded by manufacturer of the cement used for augmentation. The sponsors were reported to not have a material role in study design, data collection or reporting. In a prospective randomized control trial, Yang et al3 aimed to establish whether PVP provides extra benefits to older adults with OVCF in comparison to medical management. The authors concluded “in aged patients with acute OVCF and severe pain, early vertebroplasty yielded faster, better pain relief and improved functional outcomes, which were maintained for 1 year. Furthermore, it showed fewer complications than medical management.” This paper provides Level I evidence that vertebral augmentation resulted in improved pain control and function for first year postprocedure for patients >70 years with OVCF. In a prospective randomized control trial study, Blasco et al4 compared vertebroplasty in relation to medical management by assessing factors like quality of life and pain in patients with painful osteoporotic vertebral fractures, new fractures, and secondary adverse effects. Intrathecal infusion of bupivacaine and fentanyl was administered to patients if standard analgesic medications were ineffective or not tolerated in the conservative care group or pain improvement was inadequate in VP group. This is not a commonly offered pain control measure in clinical practice for vertebral compression fractures. This was offered to patients in both groups and is less likely to affect the validity of the results. The authors concluded “VP and conservative treatment are both associated with significant improvement in pain and quality of life in patients with painful osteoporotic VF over a 1-year follow-up period with no statistically significant differences in mortality between the two groups.” The work group downgraded this potential Level I paper due to no concealment, less than 80% follow-up, nonconsecutive patients, nonmasked reviewers, and nonmasked patients. This paper provides Level II evidence that VP and medical management provide similar significant improvement in pain and quality of life in patients with painful osteoporotic vertebral fractures over a one-year follow up period with no statistically significant differences in mortality between the two groups. VP provided greater pain relief 2 months after treatment, but was associated with an increase in new vertebral fractures. Intrathecal infusion of bupivacaine and fentanyl was administered to patients if standard analgesic medications were ineffective or not tolerated in the conservative care group or pain improvement was inadequate in VP group. This rescue therapy was required only in 3 patients in VP group compared to 15 in the CC group. In a prospective comparative study, Bornemann et al5 analyzed radiofrequency kyphoplasty and medical management, and evaluate the usual protocol of starting patients on medical management for 6 weeks before offering surgery. The authors concluded “for the vast majority of patients with a VAS >5, medical management did not provide meaningful clinical improvement. In contrast, nearly all patients who underwent radiofrequency kyphoplasty had rapid substantial improvement. Surgery was clearly much more effective than conservative care and should be offered to patients much sooner.” This paper provides Level II evidence that VA provides significant improvement in pain and function for patients who are unresponsive to 6 weeks of medical management. In a prospective comparative study, Diamond et al6 evaluated the safety and effectiveness of PVP for the treatment of patients with acute OVCF. The authors concluded that “the analgesic benefit of percutaneous vertebroplasty and the low complication rates suggest that it is a useful therapy for acute painful osteoporotic vertebral fractures.” This paper provides Level II evidence that VP provided improved pain control and function for first 6 weeks. In a prospective randomized control trial study, Jin et al7 investigated the use and impact of characteristic signal change of a linear black signal on MRI for treatment-related decision making. The authors concluded “in patients with lineal black signal detected on MRI, the first-choice treatment should be PKP rather than medical management.” The work group downgraded the level of evidence due to less than 80% follow-up and the method of randomization being suboptimal. This paper provides Level II evidence that PKP provides rapid meaningful durable relief from pain due to osteoporotic vertebral compression fractures. PKP exceeds the relief from medical management at all time points over one year. The kyphotic angle and anterior vertebral body were statistically significantly superior in the PKP group. In a prospective randomized control trial study, Leali et al8 aimed to estimate the cost effectiveness of VP in relation to medical management by evaluating pain reduction, complications, quality of life, and secondary fractures and mortality. The authors concluded “the pain and disability caused by acute osteoporotic VCFs appear to be treated with more efficacy through the VP than with the medical management alone. Are needed long-term clinical studies carefully designed and well executed for verify that VP is superior to medical management for the acute management of osteoporotic VCFs in women after menopause. Pain relief and improve mobility, functionality physics after VP are quick and significantly better in the near compared to non-surgical treatment.” The work group downgraded this potential Level I paper due to lack of raw data reported. This paper provides Level II evidence that vertebroplasty offers immediate but short-term pain relief and improvement in functional outcomes as compared to medical management. In a randomized control trial study, Li et al9 compared the therapeutic effects of PKP in relation to medical management in older adults with OVCF. The authors concluded that “as far as conservative treatment is concerned, the trauma is small, but the vertebral body could not get complete recovery and it may cause more complications. So it is only suitable for elderly patients with mild compression symptoms or intolerable to surgery. In contrast, the PKP treatment, with more immediate pain relief, greater height restoration in affected vertebras and better correction in kyphosis, is an effective alternative for treatment of OVCFs in the elderly.” The work group downgraded this potential Level I paper due to unclear randomization and a lack of details of the subgroup analysis for the controls. This paper provides Level II evidence that PKP provides rapid durable and statistically significantly greater improvements in pain and function vs medical management. In a prospective comparative study Movrin et al10 compared BKP and medical management in regards to assessing the risk factors and incidence of adjacent level fractures. The authors concluded that “BK carries a low risk of adjacent level fractures. Lower BMD values and altered biomechanics in the treated area of the spine due to resistant kyphosis are possible predictive factors for adjacent level fractures. A positive effect of BK over conventional treatment was observed upon reduction of the incidence of adjacent level fracture, vertebral morphology, and pain reduction.” This paper provides Level II evidence that vertebral augmentation with kyphoplasty improves pain and function and may decrease the rate of adjacent OVCF development one year following treatment. In a prospective randomized control trial, Rousing et al11 examined PVP versus medical management in patients with acute or subacute osteoporotic vertebral fractures by evaluating pain, and mental and physical outcomes. The authors concluded that “PVP is a good treatment for some patients with acute/subacute painful osteoporotic vertebral fractures, but the majority of fractures will heal after 8 to 12 weeks of medical management with subsequent decline in pain. The risk of new fractures needs further research.” The work group downgraded this potential Level I paper due to small sample size and some of the data being collected retrospectively. This paper provides Level II evidence that PVP may provide immediate but short-lasting pain relief and improvement in functional outcomes after acute and subacute OVCF than conservative care but mid to long term outcomes are similar Wardlaw et al12 (1-year follow-up) and Van Meirhaeghe et al13 (2-year follow-up) performed a RCT of BKP compared to nonsurgical management for patients with VCFs. A total of 99% of the patients in both groups had osteoporotic etiology and 1% had myeloma. At 2 years follow-up, there was statistically significant improvement in the EQ-5D and less Rolland – Morris disability and improvement in the PCS scale. This initial level I study was downgraded to level II with less than 80% follow up of the nonsurgical management group at 2-year follow-up, and for 1% neoplastic (myeloma) patients. This paper provides Level II evidence that clinical outcome at 2 years is better for BKP treated patient group compared to nonsurgical management patient group. This is an industry-funded study, although industry had no input in the analysis or presentation of the data. In a retrospective comparative study, Balkarli et al14 investigated the quality of life, efficacy, and functional/radiological effects of PVP versus medical management in patients with acute OVCF. The authors concluded “compared to the medical management group, PVP provides a rapid decrease of pain and an early return to daily life activities. Although improvement was observed on the radiological findings following treatment in the PVP group, PVP may not enhance the quality of life in patients with acute OVF at 6 months follow up.” This paper provides Level III evidence that vertebral augmentation provides improved pain control and function for the acute/subacute period in the first 3 months following surgery but there is no long-term difference in outcomes at 6 months. In a retrospective case control study, Colangelo et al15 studied the deformity prevention efficacy of kyphoplasty and medical management in postmenopausal women with OVCF through analyzing quality of life and recovery. The authors concluded that “kyphoplasty is a modern minimal invasive surgery, allowing faster recovery than bracing treatment. It can avoid the deformity in kyphosis due to VCF. In fact, the risk to develop a new vertebral fracture after the first one is very high.” This paper provides Level III evidence that kyphoplasty offers better pain relief and functional outcomes in short term with effect waning at 12 months. Kyphoplasty, performed early, can improve segmental alignment. In a prospective comparative study, Diamond et al16 aimed to determine whether PVP was an effective treatment for a vertebral fracture. The authors concluded “when compared with medical management, percutaneous vertebroplasty results in prompt pain relief and rapid rehabilitation. In experienced hands, it is a safe and effective procedure for treating acute osteoporotic vertebral compression fractures.” The work group downgraded this potential Level II paper due to the disparity in group sizes. This paper provides Level III evidence that PVP is more effective for pain relief and functional improvement than medical management throughout the course of treatment with more statistically significance at 24 hours but less at 6 weeks. In a retrospective comparative study, Faloon et al17 compared BKP and medical management of vertebral compression fractures. The authors concluded that “patients in the current series treated with nonoperative, medical management had a 2.28 times greater risk for a subsequent VCF than patients treated with balloon kyphoplasty and PMMA augmentation.” This paper provides Level III evidence that patients treated with BKP had fewer VCF than those treated with medical management. In a prospective comparative study, Lee et al18 evaluated the clinical outcomes of different treatment modalities in regards to patients with OVCFs, while also identifying the clinical risk factors related to the failure ofmedical management. The authors concluded “both treatments of OVCF showed successful clinical results at the end of the 1-year follow-up period. Kyphoplasty showed better outcomes in the first month only. Given these results, prompt kyphoplasty should not be indicated in the case of a patient with OVCF that has no risk factors for failure with conservative treatment. Rather, a trial of medical 3-week management would be beneficial.” The work group downgraded this potential Level II paper due to the disparity in groups and nonconsecutive patients. This paper provides Level III evidence that medical management is likely to fail in OVCF patients with severe osteoporosis, older age, obesity, and higher degree of collapse. KP improves pain and functional outcomes for one month, results thereafter being comparable with medical management. In a prospective comparative study, Ma et al19 aimed analyzed the 3-month therapeutic effects of teriparatide and percutaneous vertebroplasty on patients with acute OVCFs. The authors concluded “TPTD medical management obtained similar therapeutic effects but cost less than PVP in terms of treating acute OVCF.” The work group downgraded this potential Level II paper due to no long term follow up, small sample size, nonconsecutive patients, nonmasked patients, nonmasked reviewers, and nonrandomization. The work group concluded that this paper provides Level III evidence that percutaneous vertebroplasty showed improved pain at 1 week compared to medical management with Teriparatide. The difference was less at 1 month and similar at 3 months. Even in this study PVP patients had better pain relief (p<0.05) at one week compared to TPTD group. Furthermore, there was a significant potential for bias to select treatment option based on affordability, preference for hospitalization (all PVP and only 10% TPTD were hospitalized) and confirmation bias based on cultural influences. In a prospective comparative study, Macias-Hernandez et al20 assessed percutaneous vertebroplasty and medical management in treating women with vertebral fractures caused by osteoporosis, by evaluating pain and function. The authors concluded “treatment with percutaneous vertebroplasty had no advantages over medical management for pain and function in this group of women ≥ 60 years of age with osteoporosis.” The work group downgraded this potential Level II paper due to small sample size. This paper provides Level III evidence that VP offers immediate pain relief up to 3 months after treatment but no long-term difference as compared to structural rehabilitation program treatment. In a retrospective comparative study, Martikos et al21 compared the radiographic and clinical outcomes of medical management and PVP when it comes to treating patients with OVCF of the thoracolumbar spine. The authors concluded that “percutaneous vertebroplasty represents a safe treatment for osteoporotic vertebral compression fractures, although it may be associated with a higher incidence of adjacent fractures and therefore worse thoracolumbar kyphosis and long-term follow-up than medical management.” This paper provides Level III evidence that there was no long-term difference in pain control or function between VA and medical treatment 2 years following treatment. In a retrospective comparative study, Masala et al22 evaluated the cost effectiveness of PVP in patients with osteoporotic vertebral fractures. The authors concluded “percutaneous vertebroplasty should be considered as a valid therapeutic option in symptomatic acute osteoporotic vertebral fractures with refractory pain after a short period of analgesic drug therapy.” This paper provides Level III evidence that VP improves pain and function and is cost-effective in the short-term but loses the benefit over medical treatment over long-term. In a retrospective case control study, Nakano et al23 assessed the impact of calcium phosphate cement-based VP on the relief of pain and enlargement of the fractured vertebral body in relation tomedical management. The authors concluded that “CPC-assisted vertebroplasty provides better clinical and radiological results than medical management for primary OVCF.” The work group concluded that this paper provides Level III evidence that PVP provides durable and statistically significantly greater improvement in pain and greater reduction in use of analgesics compared to medical therapy. In a retrospective comparative study, Oh et al24 compared the safety and effectiveness of medical management (transdermal fentanyl patch) and PVP for acute OVCFs. The authors concluded that “the immediate pain reduction was superior in the PVP group, but the final clinical outcomes were similar. Although the PVP group had a better-preserved compression rate than the TFP group for 1 year, the development of adjacent fractures was significantly higher. Although TFPs seemed to be beneficial in reducing the failure rate of medical management, the possibility of side effects (22.6%, 17 out of 75 patients, in this study) should be carefully monitored.” This paper provides Level III evidence that VP provides greater immediate pain reduction than a Transdermal Fentanyl patch. After one year, pain relief was similar in the two treatment groups. VP provided superior vertebral segmental alignment. In a retrospective comparative study, Tang et al25 examined the safety and effectiveness of PVP, percutaneous kyphoplasty (PKP), and medical treatment in patients with OVCF. The authors concluded that “…PVP is a better choice for the treatment of OVCF compared with PKP or medical management.” This paper provides Level III evidence that VA procedures may offer better pain relief and functional outcomes immediately as compared to medical management for OVCF with loss of effect in the mid-term. PKP improves segmental alignment but is the most expensive treatment. In a prospective comparative study, Wang et al26 compared the effectiveness of PVP in relation to medical management in the treatment of patients with acute VCFs. The authors concluded “pain relief, physical functioning improvement, and medication requirement after vertebroplasty are immediately and significantly better when compared with medical management.” The work group downgraded this potential Level II paper due to there being no intermediate follow-up. This paper provides Level III evidence that VA provided improve pain control and function up to 4 weeks postprocedure but no difference at 1 year. Pain relief and functional outcomes may be immediate and better after PV than medical management in the short-term with no difference at 12 months.
References: 1. Farrokhi MR, Alibai E, Maghami Z. Randomized controlled trial of percutaneous vertebroplasty versus optimal medical management for the relief of pain and disability in acute osteoporotic vertebral compression fractures. J Neurosurg Spine. 2011;14(5):561-569. doi:10.3171/2010.12.SPINE10286. 2. Klazen CA, Lohle PN, de Vries J, et alVertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010;376(9746):1085-1092. doi:10.1016/S0140-6736(10)60954-3 3. Yang EZ, Xu JG, Huang GZ, et al. Percutaneous Vertebroplasty Versus Conservative Treatment in Aged Patients With Acute Osteoporotic Vertebral Compression Fractures: A Prospective Randomized Controlled Clinical Study. Spine (Phila Pa 1976). 2016;41(8):653-660. doi:10.1097/BRS.0000000000001298 4. Blasco J, Martinez-Ferrer A, Macho J, et al. Effect of vertebroplasty on pain relief, quality of life, and the incidence of new vertebral fractures: a 12-month randomized follow-up, controlled trial. J Bone Miner Res. 2012;27(5):1159-1166. doi:10.1002/jbmr.1564’ 5. Bornemann R, Hanna M, Kabir K, Goost H, Wirtz DC, Pflugmacher R. Continuing conservative care versus crossover to radiofrequency kyphoplasty: a comparative effectiveness study on the treatment of vertebral body fractures. Eur Spine J. 2012;21(5):930-936. doi:10.1007/s00586-012-2148-8 6. Diamond TH, Bryant C, Browne L, Clark WA. Clinical outcomes after acute osteoporotic vertebral fractures: a 2-year non-randomised trial comparing percutaneous vertebroplasty with conservative therapy. Med J Aust. 2006;184(3):113-117. doi:10.5694/j.1326-5377.2006.tb00148.x 7. Jin C, Xu G, Weng D, Xie M, Qian Y. Impact of Magnetic Resonance Imaging on Treatment-Related Decision Making for Osteoporotic Vertebral Compression Fracture: A Prospective Randomized Trial. Med Sci Monit. 2018;24:50-57. doi:10.12659/msm.905729 8. Leali PT, Solla F, Maestretti G, Balsano M, Doria C. Safety and efficacy of vertebroplasty in the treatment of osteoporotic vertebral compression fractures: a prospective multicenter international randomized controlled study. Clin Cases Miner Bone Metab. 2016;13(3):234-236. doi:10.11138/ccmbm/2016.13.3.234 9. Li Y, Zhu J, Xie C. A comparative study of percutaneous kyphoplasty and conservative therapy on vertebral osteoporotic compression fractures in elderly patients. Int J Clin Expl Med. 2017;10(5):8139-8145. 10. Movrin I. Adjacent level fracture after osteoporotic vertebral compression fracture: a nonrandomized prospective study comparing balloon kyphoplasty with conservative therapy. Wien Klin Wochenschr. 2012;124(9-10):304-311. doi:10.1007/s00508-012-0167-4 11. Rousing R, Hansen KL, Andersen MO, Jespersen SM, Thomsen K, Lauritsen JM. Twelve-months follow-up in forty-nine patients with acute/semiacute osteoporotic vertebral fractures treated conservatively or with percutaneous vertebroplasty: a clinical randomized study. Spine (Phila Pa 1976). 2010;35(5):478-482. doi:10.1097/BRS.0b013e3181b71bd1 12. Wardlaw D, Cummings SR, Van Meirhaeghe J, et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. 2009;373(9668):1016-1024. doi:10.1016/S0140-6736(09)60010-6 13. Van Meirhaeghe J, Bastian L, Boonen S, et al. A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures: vertebral body kyphosis correction and surgical parameters. Spine (Phila Pa 1976). 2013;38(12):971-983. doi:10.1097/BRS.0b013e31828e8e22 14. Balkarli H, Kilic M, Balkarli A, Erdogan M. An evaluation of the functional and radiological results of percutaneous vertebroplasty versus conservative treatment for acute symptomatic osteoporotic spinal fractures. Injury. 2016;47(4):865-871. doi:10.1016/j.injury.2016.01.041 15. Colangelo D, Nasto LA, Genitiempo M, et al. Kyphoplasty vs conservative treatment: a case-control study in 110 post-menopausal women population. Is kyphoplasty better than conservative treatment? Eur Rev Med Pharmacol Sci. 2015;19(21):3998-4003. 16. Diamond TH, Champion B, Clark WA. Management of acute osteoporotic vertebral fractures: a nonrandomized trial comparing percutaneous vertebroplasty with conservative therapy. Am J Med. 2003;114(4):257-265. doi:10.1016/s0002-9343(02)01524-3 17. Faloon MJ, Ruoff M, Deshpande C, et al. Risk Factors Associated with Adjacent and Remote- Level Pathologic Vertebral Compression Fracture Following Balloon Kyphoplasty: 2-Year Follow-Up Comparison Versus Conservative Treatment. J Long Term Eff Med Implants. 2015;25(4):313-319. doi:10.1615/jlongtermeffmedimplants.2015013971 18. Lee HM, Park SY, Lee SH, Suh SW, Hong JY. Comparative analysis of clinical outcomes in patients with osteoporotic vertebral compression fractures (OVCFs): conservative treatment versus balloon kyphoplasty. Spine J. 2012;12(11):998-1005. doi:10.1016/j.spinee.2012.08.024. 19. Ma Y, Wu X, Xiao X, et al. Effects of teriparatide versus percutaneous vertebroplasty on pain relief, quality of life and cost-effectiveness in postmenopausal females with acute osteoporotic vertebral compression fracture: A prospective cohort study. Bone. 2020;131:115154. doi:10.1016/j.bone.2019.115154 20. Macías-Hernández SI, Chávez-Arias DD, Miranda-Duarte A, Coronado-Zarco R, Diez-García MP. Percutaneous Vertebroplasty Versus Conservative Treatment and Rehabilitation in Women with Vertebral Fractures due to Osteoporosis: A Prospective Comparative Study. Rev Invest Clin. 2015;67(2):98-103. 21. Martikos K, Greggi T, Faldini C, Vommaro F, Scarale A. Osteoporotic thoracolumbar compression fractures: long-term retrospective comparison between vertebroplasty and conservative treatment. Eur Spine J. 2018;27(Suppl 2):244-247. doi:10.1007/s00586-018-5605-1 22. Masala S, Ciarrapico AM, Konda D, Vinicola V, Mammucari M, Simonetti G. Cost-effectiveness of percutaneous vertebroplasty in osteoporotic vertebral fractures. Eur Spine J. 2008;17(9):1242-1250. doi:10.1007/s00586-008-0708-8. 23. Nakano M, Hirano N, Ishihara H, Kawaguchi Y, Watanabe H, Matsuura K. Calcium phosphate cement-based vertebroplasty compared with conservative treatment for osteoporotic compression fractures: a matched case-control study. J Neurosurg Spine. 2006;4(2):110-117. doi:10.3171/spi.2006.4.2.110 24. Oh Y, Lee B, Lee S, Kim J, Park J. Percutaneous Vertebroplasty versus Conservative Treatment Using a Transdermal Fentanyl Patch for Osteoporotic Vertebral Compression Fractures. J Korean Neurosurg Soc. 2019;62(5):594-602. doi:10.3340/jkns.2019.0086 25. Tang H, Zhao J, Hao C. Osteoporotic vertebral compression fractures: surgery versus non-operative management. J Int Med Res. 2011;39(4):1438-1447. doi:10.1177/147323001103900432 26. Wang HK, Lu K, Liang CL, et al. Comparing clinical outcomes following percutaneous vertebroplasty with conservative therapy for acute osteoporotic vertebral compression fractures. Pain Med. 2010;11(11):1659-1665. doi:10.1111/j.1526-4637.2010.00959.x.
Vertebral augmentation is suggested to improve the segmental alignment compared to medical treatment in adults with osteoporotic vertebral compression fractures.
Percutaneous vertebroplasty provides durable and statistically significantly greater improvement in pain and greater reduction in use of analgesics compared to medical therapy.Grade of Recommendation: B In a retrospective case control study, Colangelo et al1 compared the deformity prevention efficacy of kyphoplasty and medical management in postmenopausal women with OVCF through analyzing quality of life and recovery. The authors concluded that “kyphoplasty is a modern minimal invasive surgery, allowing faster recovery than bracing treatment. It can avoid the deformity in kyphosis due to VCF. In fact, the risk to develop a new vertebral fracture after the first one is very high.” This paper provides Level III evidence that kyphoplasty offers better pain relief and functional outcomes in short term with effect waning at 12 months. Kyphoplasty, performed early, can improve segmental alignment. In a retrospective case control study, Nakano et al2 aimed to assess the impact of calcium phosphate cement-based VP on the relief of pain and enlargement of the fractured vertebral body in relation to conservative treatment. The authors concluded that “CPC-assisted vertebroplasty provides better clinical and radiological results than conservative treatment for primary OVCF.” This paper provides Level III evidence that (1) PVP with PCP provides durable and statistically significantly greater improvement in pain and vertebral morphology. There was a statistically significant reduction in analgesic consumption in the patients treated with PVP vs medical treatment groups. In a retrospective comparative study, Oh et al3 investigated the safety and effectiveness of medical management (transdermal fentanyl patch) vs PVP for acute OVCFs. The authors concluded that “the immediate pain reduction was superior in the PVP group, but the final clinical outcomes were similar. Although the PVP group had a better-preserved compression rate than the TFP group for 1 year, the development of adjacent fractures was significantly higher. Although TFPs seemed to be beneficial in reducing the failure rate of medical management, the possibility of side effects (22.6%, 17 out of 75 patients, in this study) should be carefully monitored.” This paper provides Level III evidence that vertebroplasty provides greater immediate pain reduction than a Transdermal Fentanyl patch. After one year, pain relief was similar in the two treatment groups. PVP provided superior vertebral segmental alignment. In a retrospective comparative study, Tang et al4 studied the safety and effectiveness of PVP, PKP, and medical management in patients with OVCF. The authors concluded that “…PVP is a better choice for the treatment of OVCF compared with PKP or medical management.” This paper provides Level III evidence that vertebral augmentation procedures may offer better pain relief and functional outcomes immediately as compared to medical management for OVCF with loss of effect in the mid-term. PKP improves segmental alignment but is the most expensive treatment. References: 1. Colangelo D, Nasto LA, Genitiempo M, et al. Kyphoplasty vs conservative treatment: a case-control study in 110 post-menopausal women population. Is kyphoplasty better than conservative treatment?. Eur Rev Med Pharmacol Sci. 2015;19(21):3998-4003. 2. Nakano M, Hirano N, Ishihara H, Kawaguchi Y, Watanabe H, Matsuura K. Calcium phosphate cement-based vertebroplasty compared with conservative treatment for osteoporotic compression fractures: a matched case-control study. J Neurosurg Spine. 2006;4(2):110-117. doi:10.3171/spi.2006.4.2.110 3. Oh Y, Lee B, Lee S, Kim J, Park J. Percutaneous Vertebroplasty versus Conservative Treatment Using a Transdermal Fentanyl Patch for Osteoporotic Vertebral Compression Fractures. J Korean Neurosurg Soc. 2019;62(5):594-602. doi:10.3340/jkns.2019.0086 4. Tang H, Zhao J, Hao C. Osteoporotic vertebral compression fractures: surgery versus non-operative management. J Int Med Res. 2011;39(4):1438-1447. doi:10.1177/147323001103900432
There is conflicting evidence to make a recommendation for or against vertebral augmentation compared to medical treatment in terms of new, adjacent-level, or distant fractures in adults with osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a prospective comparative study, Movrin et al1 compared BKP and medical management in regards to assessing the risk factors and incidence of adjacent level fractures. The authors concluded that “BK carries a low risk of adjacent level fractures. Lower BMD values and altered biomechanics in the treated area of the spine due to resistant kyphosis are possible predictive factors for adjacent level fractures. A positive effect of BK over conventional treatment was observed upon reduction of the incidence of adjacent level fracture, vertebral morphology, and pain reduction.” This paper provides Level II evidence that VA with kyphoplasty improves pain and function and may decrease the rate of adjacent OVCF development one year following treatment. In a prospective comparative study, Yi et al2 analyzed the incidence and risk factors of symptomatic OVCF in patients who were treated by PVP and PKP in relation to medical management. The authors concluded that “patients who had experienced PVP/PKP were not associated with an increased risk of recompression in new levels. However, recompression in new levels of PVP/PKP group occurred much sooner than that of medical management group in the follow-up period. The incidence of new vertebral fractures observed at adjacent levels was substantially higher but no sooner than at distant levels in PVP/PKP group.” This paper provides Level II evidence that treatment with PVP or PKP was not associated with increased risk of additional fractures at new vertebral levels. Adjacent segment fractures appear earlier in the treatment group, although overall additional fractures are comparable. In a retrospective comparative study, Faloon et al3 compared BKP and medical management of VCF. The authors concluded that “patients in the current series treated with nonoperative, medical management had a 2.28 times greater risk for a subsequent VCF than patients treated with balloon kyphoplasty and PMMA augmentation.” This paper provides Level III evidence that patients treated with balloon kyphoplasty had less vertebral compression fractures than those treated with medical management. In a retrospective comparative study, Martikos et al4 compared the radiographic and clinical outcomes of medical management and PVP when it comes to treating patients with OVCF of the thoracolumbar spine. The authors concluded that “percutaneous vertebroplasty represents a safe treatment for osteoporotic vertebral compression fractures, although it may be associated with a higher incidence of adjacent fractures and therefore worse thoracolumbar kyphosis and long-term follow-up than medical management.” This paper provides Level III evidence that there was no long-term difference in pain control or function between vertebral augmentation and medical treatment 2 years following treatment. References: 1. Movrin I. Adjacent level fracture after osteoporotic vertebral compression fracture: a nonrandomized prospective study comparing balloon kyphoplasty with conservative therapy. Wien Klin Wochenschr. 2012;124(9-10):304-311. doi:10.1007/s00508-012-0167-4 2. Yi X, Lu H, Tian F, et al. Recompression in new levels after percutaneous vertebroplasty and kyphoplasty compared with conservative treatment. Arch Orthop Trauma Surg. 2014;134(1):21-30. doi:10.1007/s00402-013-1886-3 3. Faloon MJ, Ruoff M, Deshpande C, et al. Risk Factors Associated with Adjacent and Remote- Level Pathologic Vertebral Compression Fracture Following Balloon Kyphoplasty: 2-Year Follow-Up Comparison Versus Conservative Treatment. J Long Term Eff Med Implants. 2015;25(4):313-319. doi:10.1615/jlongtermeffmedimplants.2015013971 4. Martikos K, Greggi T, Faldini C, Vommaro F, Scarale A. Osteoporotic thoracolumbar compression fractures: long-term retrospective comparison between vertebroplasty and conservative treatment. Eur Spine J. 2018;27(Suppl 2):244-247. doi:10.1007/s00586-018-5605-1
FLASK Future Directions for Research
The work group recommends additional studies looking at other factors such as QoL, cost effectiveness, short- and long-term complications, and duration of symptom control as well as studies to evaluate optimal timing for vertebral augmentation in adults with osteoporotic vertebral compression fractures.
Interventional Treatment Question 4: Does mechanical device (an implant that includes more than a bone filler) improve outcomes in patients with symptomatic osteoporotic vertebral compression fractures compared to medical care?
A systematic review of the literature yielded no studies to adequately address this question.
FLASK Future Directions for Research
The work group recommends high-quality studies for these devices compared to standard medical care and their effectiveness in maintaining stability and in height restoration.
Interventional Treatment Question 5: Does the correction of vertebral height loss or segmental kyphosis during vertebral augmentation for symptomatic osteoporotic vertebral compression fractures result in improved clinical outcomes?
For adults with osteoporotic vertebral compression fractures containing vertebral cleft, it is suggested that vertebral augmentation can improve height and wedge angle, but this restoration has no significant difference in pain relief.
Grade of Recommendation: B
In a retrospective comparative study, Chen et al1 explored the clinical and radiological characteristics of intravertebral clef in OVCF, and its effect on the effectiveness of PKP. The authors concluded that “Intravertebral cleft exhibits specific clinical and imaging as well as bone cement formation characteristics. PKP can effectively restore the affected vertebral body height, alleviate pain, and improve daily activity function of patients.” This paper provides Level III evidence that restored height was statistically significant in the cleft group but there was no significant difference in pain relief or outcomes. In a retrospective comparative study, Sun et al2 evaluated the impact of vertebroplasty on restoration of vertebral body height, wedge angle, and relief from pain patients with OVCF. The authors concluded that “Most patients experienced pain relief after vertebroplasty. After vertebroplasty, the height and wedge angle were significantly improved in the cleft group (p0.05).” This paper provides Level III evidence that while height and wedge angle may be improved in patients with vertebral cleft, compared to without cleft, there was no significant difference in pain relief. References: 1. Chen B, Fan S, Zhao F. Percutaneous balloon kyphoplasty of osteoporotic vertebral compression fractures with intravertebral cleft. Indian J Orthop. 2014;48(1):53-59. doi:10.4103/0019-5413.125498 2. Sun G, Jin P, Li M, Liu XW, Li FD. Height restoration and wedge angle correction effects of percutaneous vertebroplasty: association with intraosseous clefts. Eur Radiol. 2011;21(12):2597-2603. doi:10.1007/s00330-011-2218-z
It is suggested that kyphoplasty shows improved height restoration and kyphotic angle, but degree of height restoration and kyphotic angle did not provide further improvement in pain relief or function in adults with osteoporotic vertebral compression fractures.
Grade of Recommendation: B
In a retrospective comparative study, Chi et al1 evaluated the radiological and comparative outcomes of kyphoplasty with an intravertebral reduction device and vertebroplasty for treating OVCF-associated spinal canal encroachment. The authors concluded that “KP with IRD was associated with better body heights and KA at least for 1 year for OVCF-associated SCE with noninferior clinical outcomes to VP.” This paper provides Level III evidence that kyphoplasty with a reduction device showed a significant difference in height restoration and improved kyphotic angle but no difference in pain relief or outcomes. In a retrospective comparative study, Palmowski et al2 aimed to determine the relationship between operative timing and early postoperative radiological and clinical outcomes after kyphoplasty. The authors concluded that “Kyphoplasty is effective for vertebral height restoration as well as pain relief for both acute, subacute and chronic fractures. However, the achievable correction of the fracture-related local kyphosis decreases significantly after 6 weeks.” This paper provides Level III evidence that optimal correction of fracture-related local kyphosis improves if kyphoplasty is performed within 6-weeks after fracture onset. After 6-weeks, correction of the local kyphosis attributed to the fracture significantly decreases. VAS was not significantly different between groups, but medication use decreased in acute and subacute groups, but not statistically different from the nonacute group. In a retrospective comparative study, Park et al3 examined the spinal deformity and pain scores before and after BKP is performed within 2 weeks or 2 weeks after fracture. The authors concluded that “in an attempt to improve the reliability and extent of fracture reduction, one might consider performing kyphoplasty soon after fracture occurrence. It is considered more cost-effective because early treatment and early return to society can reduce the social costs.” This paper provides Level III evidence that KP performed within 2 weeks of fracture onset in female patients with single-level OVCF provides better restoration of VBH and improvement in Cobb angle. However, timing of intervention does not seem to impact self-reported back pain at 3-month follow-up. In a retrospective comparative study, Zhou et al4 aimed to determine whether surgical timing could impact the clinical and radiological outcomes in patients with OVCF, who were undergoing PKP. The authors concluded that “Both surgical timings of PKP showed similar outcomes in terms of the VAS and ODI. Early PKP could result in better restoration of vertebral body height and reduced rate of subsequent fracture compared to late PKP.” This paper provides Level III evidence that early kyphoplasty less than 4 weeks after fracture onset provides better height restoration and lower rate of subsequent fracture compared to PKP after 4 weeks. Clinical outcomes in terms of VAS and ODI at follow-up are comparable. In a prospective case series study, Arabmotlagh et al5 assessed the effectiveness of kyphoplasty using an expandable device as a means to correct the kyphotic deformity, and to evaluate the parameters that affect the restoration and preservation of spinal alignment. The authors concluded that “The results of our study indicate that small corrections of spinal deformities by kyphoplasty or the loss of correction over the follow-up period do not correlate with pain improvement. Furthermore, the correction of the kyphotic deformity, which is the main goal of kyphoplasty, seems to have an adverse effect on further subsidence.” This paper provides Level IV evidence that that a small correction of spine deformity by kyphoplasty does not correlate with improvement in pain. In a retrospective case series study, Zapalowicz et al6 studied the efficacy of percutaneous balloon kyphoplasty in the treatment of compression vertebral fractures. The authors concluded that “Rapid significant pain relief after kyphoplasty followed by long-term pain release and disability reduction obtained in all patients was most probably the result of vertebral augmentation. The correction of local kyphosis had no influence on the outcome.” This paper provides Level IV evidence that the correction of local kyphosis with kyphoplasty had no effect on pain relief or disability. References: 1. Chi JE, Hsu JY, Chan R, Lo WC, Chiang YH, Lin JH. Kyphoplasty with an intravertebral reduction device for osteoporotic vertebral compression fractures with spinal canal encroachment. Formosan J Surg. 2020;53(1):20-28. 2. Palmowski Y, Balmer S, Bürger J, Schömig F, Hu Z, Pumberger M. Influence of operative timing on the early post-operative radiological and clinical outcome after kyphoplasty. Eur Spine J. 2020;29(10):2560-2567. doi:10.1007/s00586-020-06491-8 3. Park HT, Lee CB, Ha JH, Choi SJ, Kim MS, Ha JM. Results of kyphoplasty according to the operative timing. Curr Orthop Pract. 2010;21(5):489-493. 4. Zhou X, Meng X, Zhu H, Zhu Y, Yuan W. Early versus late percutaneous kyphoplasty for treating osteoporotic vertebral compression fracture: A retrospective study. Clin Neurol Neurosurg. 2019;180:101-105. doi:10.1016/j.clineuro.2019.03.029 5. Arabmotlagh M, Nikoleiski SC, Schmidt S, Rauschmann M, Rickert M, Fleege C. Radiological evaluation of kyphoplasty with an intravertebral expander after osteoporotic vertebral fracture. J Orthop Res. 2019;37(2):457-465. doi:10.1002/jor.24180. 6. Zapałowicz K, Radek M. Percutaneous balloon kyphoplasty in the treatment of painful vertebral compression fractures: effect on local kyphosis and one-year outcomes in pain and disability. Neurol Neurochir Pol. 2015;49(1):11-15. doi:10.1016/j.pjnns.2014.11.005
It is suggested that vertebroplasty and kyphoplasty, regardless of height restoration or kyphotic angle improvement, are equivalent in providing pain relief and improved function in adults with osteoporotic vertebral compression fractures.
Grade of Recommendation: B
In a prospective comparative study, Du et al1 compared kyphoplasty and VP by analyzing the 2-year clinical and radiographic outcomes of each in the treatment of painful osteoporotic vertebral compression fractures. The authors concluded that “Given similarly clinical efficacy, relative cost may be an important indicator of the more appropriate procedure. Therefore, the cost-effectiveness of kyphoplasty versus vertebroplasty needs to be investigated in future study.” This paper provides Level II evidence that there is no difference between kyphoplasty and VP in VAS and ODI improvement. In a prospective comparative study, Liu et al2 investigated the radiological and clinical outcomes of kyphoplasty and VP in the treatment of spinal axial deformities in patients who had osteoporotic vertebral compression fractures. The authors concluded that “In terms of clinical outcome there was little difference between the treatment groups. Thus, with the higher cost of the kyphotic balloon procedure, we recommend vertebroplasty over kyphoplasty for the treatment of osteoporotic VCFs.” This paper provides Level II evidence that kyphoplasty did have a significant improvement in height over VP but this made no difference in pain. In a retrospective comparative study, Bozkurt et al3 analyzed the effectiveness and outcomes (pain, functional capacity, and height restoration rates) of VP in comparison to unipedicular and bipedicular kyphoplasty for the treatment of OVCF. The authors concluded that “Vertebroplasty and kyphoplasty are both effective in providing pain relief and improvement in functional capacity and quality of life after the procedure, but the bipedicular kyphoplasty procedure has a further advantage in terms of height restoration when compared to unipedicular kyphoplasty and vertebroplasty procedures.” This paper provides Level III evidence that while the bipedicular KP procedure provides superior vertebral height restoration, both unipedicular and bipedicular KP and VP procedures provide effective pain relief. In a retrospective comparative study, Cheng et al4 analyzed the effectiveness and safety of PVP in comparison to BKP in the treatment of newly onset osteoporotic vertebral compression fractures. The authors concluded that “Considering the significantly less cost of VP than BKP, we recommend prioritizing VP over BKP for patients with newly onset osteoporotic VCF.” This paper provides Level III evidence that there is no significant difference between the two techniques in VAS and ODI. In a retrospective comparative study, Gan et al5 evaluated the effectiveness and safety of PVP in comparison to BKP in treating osteoporotic vertebral biconcave-shaped fractures. The authors concluded that “Both PV and BKP achieved similar improvements in pain and functional outcomes for the treatment of osteoporotic vertebral biconcave-shaped fractures. BKP had a significant advantage over PV in terms of the restoration of the middle vertebral height and fewer cement leakages than PV.” This paper provides Level III evidence that BKP was superior in restoration of middle vertebral height, however VAS and ODI improvements were similar in BKP and PVP. In a retrospective comparative study, Hu et al6 examined the clinical effectiveness of PKP in comparison to PVP in the treatment of osteoporotic thoracolumbar vertebral compression fractures. The authors concluded that “The clinical effects of both PKP and PVP in the treatment of OVCF are good, of which the reductive and analgesic effect of PKP is superior to that of PVP and the former has less leakage of cement, higher safety and fewer complications.” This paper provides Level III evidence that kyphoplasty is superior to VP in restoration of vertebral height, cobb angle correction, pain, and function in patients with osteoporotic vertebral compression fractures.
In a retrospective comparative study, Kim et al7 compared the effectiveness of the treatments, VP and kyphoplasty, by assessing the kyphosis correction, vertebral height restoration, and bone cement leakage in patients with osteoporotic vertebral compression fractures. The authors concluded that “KP has a significant advantage over VP in terms of kyphosis correction, vertebral height restoration, and cement leakage prevention. KP has an obvious advantage in terms of middle vertebral height restoration and cement leakage prevention, especially for V-shape compression fractures.” This paper provides Level III evidence that kyphoplasty had advantages in middle vertebral height restoration and cement leakage, but for pain relief it was similar to VP. In a retrospective comparative study, Lin et al8 investigated the radiological and clinical outcomes of kyphoplasty with intravertebral reduction device (IRD) in comparison to vertebroplasty for treating OVCF. The authors concluded that “Our findings reveal significantly more efficient height restoration and kyphosis correction and fewer refractures in the IRD group. IRD may not increase the risk of adjacent or nonadjacent fractures.” This paper provides Level III evidence that KP was superior in height restoration and kyphosis correction, however pain improvement was similar in KP and VP. In a prospective comparative study, Röllinghoff et al9 compared the effectiveness, safety, restoration of VBG, and complication rates of kyphoplasty and vertebroplasty. Another aim of this study is to use its data to assist in reducing the rate of serious complications in both of the procedures. The authors concluded that “There were no differences between the groups with regard to quality of life and pain improvement, but the rate of serious complications was higher after vertebroplasty. Mean vertebral body height restoration at 1 year follow-up was significantly higher (p < 0.05) in the kyphoplasty group.” This paper provides Level III evidence that there was no difference in QoL or pain improvement between both procedues. Vertebral body height was significantly better in KP. In a prospective comparative study, Schofer et al10 compared kyphoplasty and VP by evaluating both procedures’ in terms of pain, postoperative quality of life, angle of kyphosis, and cement leakage, in the treatment of fresh VCFS. The authors concluded that “The two surgical procedures were both followed by significant pain relief, and the quality of life was similar regardless of the procedure used. Balloon kyphoplasty led to an ongoing reduction of freshly fractured vertebrae and was followed by a lower rate of cement leakage.” This paper provides Level III evidence that kyphoplasty did have a significant improvement in height over VP but this made no difference in pain and function. References: 1. Du J, Li X, Lin X. Kyphoplasty versus vertebroplasty in the treatment of painful osteoporotic vertebral compression fractures: two-year follow-up in a prospective controlled study. Acta Orthop Belg. 2014;80(4):477-486. 2. Liu JT, Liao WJ, Tan WC, et al. Balloon kyphoplasty versus vertebroplaty for treatment of osteoporotic vertebral compression fracture: A prosperctive, comprarative, and randomized clinical study. Osteoporos Int. 2010;21:359–64. 3. Bozkurt M, Kahilogullari G, Ozdemir M, et al. Comparative analysis of vertebroplasty and kyphoplasty for osteoporotic vertebral compression fractures. Asian Spine J. 2014;8(1):27-34. doi:10.4184/asj.2014.8.1.27 4. Cheng J, Muheremu A, Zeng X, Liu L, Liu Y, Chen Y. Percutaneous vertebroplasty vs balloon kyphoplasty in the treatment of newly onset osteoporotic vertebral compression fractures: A retrospective cohort study. Medicine (Baltimore). 2019;98(10):e14793. doi:10.1097/MD.0000000000014793. 5. Gan M, Zou J, Song D, Zhu X, Wang G, Yang H. Is balloon kyphoplasty better than percutaneous vertebroplasty for osteoporotic vertebral biconcave-shaped fractures?. Acta Radiol. 2014;55(8):985-991. doi:10.1177/0284185113511603 6. Hu KZ, Chen SC, Xu L. Comparison of percutaneous balloon dilation kyphoplasty and percutaneous vertebroplasty in treatment for thoracolumbar vertebral compression fractures. Eur Rev Med Pharmacol Sci. 2018;22(1 Suppl):96-102. doi:10.26355/eurrev_201807_15370 7. Kim KH, Kuh SU, Chin DK, et al. Kyphoplasty versus vertebroplasty: restoration of vertebral body height and correction of kyphotic deformity with special attention to the shape of the fractured vertebrae. J Spinal Disord Tech. 2012;25(6):338-344. doi:10.1097/BSD.0b013e318224a6e6 8. Lin JH, Wang SH, Lin EY, Chiang YH. Better Height Restoration, Greater Kyphosis Correction, and Fewer Refractures of Cemented Vertebrae by Using an Intravertebral Reduction Device: a 1-Year Follow-up Study. World Neurosurg. 2016;90:391-396. doi:10.1016/j.wneu.2016.03.009 9. Röllinghoff M, Siewe J, Zarghooni K, et al. Effectiveness, security and height restoration on fresh compression fractures--a comparative prospective study of vertebroplasty and kyphoplasty. Minim Invasive Neurosurg. 2009;52(5-6):233-237. doi:10.1055/s-0029-1243631 10. Schofer MD, Efe T, Timmesfeld N, Kortmann HR, Quante M. Comparison of kyphoplasty and vertebroplasty in the treatment of fresh vertebral compression fractures. Arch Orthop Trauma Surg. 2009;129:1391– 9. [PubMed][Google Scholar].
FLASK Future Directions for Research
The work group does not have any recommendations for future research on this topic.
Interventional Treatment Question 6: For patients with symptomatic acute osteoporotic vertebral compression fractures, what is the optimal timing for vertebral augmentation?
In adults with osteoporotic vertebral compression fractures, it is suggested that there is optimal timing for treatment with vertebral augmentation and delayed treatment is associated with worse clinical outcomes.
Grade of Recommendation: B
In a prospective randomized control trial study, Diamond et al1 evaluated the safety and effectiveness of early VP on patients with acute painful vertebral osteoporotic fractures, that were done within 3 weeks of fracture onset in the VAPOUR study. The authors concluded that “Analysis of this patient subgroup from the VAPOUR trial, in the context of other randomised trial evidence, suggests clinically significant benefits from early vertebroplasty if performed within 3 weeks of fracture.” This paper provides Level I evidence that early VP done within ≤ 3 weeks of fracture onset shows clinically important benefits in terms of lower NRS pain scores and lower RMDQ at up to 6 months. In a prospective comparative study, Erkan et al2 compared the clinical and radiological outcomes, as well as the complication rates of symptomatic acute (<10 weeks) and nonacute (>16 weeks) OVCF that were treated with kyphoplasty. The authors concluded that “Kyphoplasty improves clinical and radiological outcomes in patients having either acute (< 10 weeks) or chronic (> 16 weeks) VCFs. The outcomes are mostly better in the acute group, but not always significantly. This means that timing of kyphoplasty really matters, although the difference between acute and chronic fractures is more striking from a radiological view-point than from a clinical view-point.” The work group downgraded this potential Level II paper due to small sample size, poor statistical methods, nonmasked reviewed, and the study not being randomized. This paper provides Level III evidence that the timing of kyphoplasty that is up to 2.5 months after injury has more favorable outcomes compared to nonacute fractures. In a prospective comparative study, Takahashi et al3 studied the differences in the surgical outcomes of osteoporotic vertebral fractures, in relation to the timing of BKP (early would be 2 or less months and late would be later than 2 months). The authors concluded that “Vertebral height and kyphotic angle before and after balloon kyphoplasty were greater in patients who underwent kyphoplasty within 2 months after onset, and the VAS score for low back pain at final follow-up was better. Our results support kyphoplasty within 2 months.” This paper provides Level II evidence that patients over 65 years old with OVCF and undergoing BKP within 2 months have significantly lower back pain scores at final follow-up (after 6 months) compared to those after 2 months. In a retrospective comparative study, Minamide et al4 aimed to determine the effect of the timing of intervention, more specifically the timing of percutaneous BKP, on clinical and radiological outcomes when treating osteoporotic vertebral fractures. The authors concluded that “BKP is able to prevent progressive collapse and kyphosis after OVF, but not effectively restore alignment, and as a result, patients who undergo early BKP (< 4 weeks) demonstrate better alignment, better LBP scores, and reduced rates of subsequent fracture at an average of 1.2 years following treatment.” This paper provides Level III evidence that patients undergoing early KP have better radiological and clinical outcomes at 1.2 years follow-up. In a retrospective comparative study, Son et al5 compared the outcomes of early VP and delayed VP for the treatment of single-level acute OVCF in the thoracolumbar junction, as a means to determine whether the timings of surgery would have an impact on the outcome and cost-effectiveness. The authors concluded that “Our findings suggest that EVP achieves a better immediate surgical effect with more favorable cost-effectiveness.” This paper provides Level III evidence that patients undergoing early VP (<2 weeks) have better pain control in the immediate postop duration, have lower chance of cement leakage, and incur shorter hospital stay when compared to VP performed within 2-6 weeks. In a retrospective comparative study, Yang et al6 assessed the incidence of adjacent vertebral fractures among patients who had received early PVP or late PVP in the thoracolumbar region after a 1-year follow-up. The authors concluded that “Compared with later interventions, PVP performed within 30 days after fracture development may be associated with a lower risk of adjacent fractures in the thoracolumbar region.” This paper provides Level III evidence that PVP performed after 4 weeks of fracture onset is associated with increased hazards for adjacent vertebral fractures at one-year postop. Early PVP is associated with higher percentage of improvement in postop VAS scores compared to their preop values. References: 1. Diamond T, Clark W, Bird P, Gonski P, Barnes E, Gebski V. Early vertebroplasty within 3 weeks of fracture for acute painful vertebral osteoporotic fractures: subgroup analysis of the VAPOUR trial and review of the literature. Eur Spine J. 2020;29(7):1606-1613. doi:10.1007/s00586-020-06362-2. 2. Erkan S, Ozalp TR, Yercan HS, Okcu G. Does timing matter in performing kyphoplasty? Acute versus chronic compression fractures. Acta Orthop Belg. 2009;75(3):396-404. 3. Takahashi S, Hoshino M, Terai H, et al. Differences in short-term clinical and radiological outcomes depending on timing of balloon kyphoplasty for painful osteoporotic vertebral fracture. J Orthop Sci. 2018;23(1):51-56. doi:10.1016/j.jos.2017.09.019 4. Minamide A, Maeda T, Yamada H, et al. Early versus delayed kyphoplasty for thoracolumbar osteoporotic vertebral fractures: The effect of timing on clinical and radiographic outcomes and subsequent compression fractures. Clin Neurol Neurosurg. 2018;173:176-181. doi:10.1016/j.clineuro.2018.07.019 5. Son S, Lee SG, Kim WK, Park CW, Yoo CJ. Early Vertebroplasty versus Delayed Vertebroplasty for Acute Osteoporotic Compression Fracture : Are the Results of the Two Surgical Strategies the Same?. J Korean Neurosurg Soc. 2014;56(3):211-217. doi:10.3340/jkns.2014.56.3.211 6. Yang CC, Chien JT, Tsai TY, Yeh KT, Lee RP, Wu WT. Earlier Vertebroplasty for Osteoporotic Thoracolumbar Compression Fracture May Minimize the Subsequent Development of Adjacent Fractures: A Retrospective Study. Pain Physician. 2018;21(5):E483-E491.
FLASK Future Directions for Research
The work group recommends to consider investigation of large databases to seek verification of the exact optimal timing for vertebral augmentation in the acute phase.
Interventional Treatment Question 7: Does vertebral augmentation improve clinical outcomes in patients with back pain and an intravertebral cleft on imaging of chronic osteoporotic vertebral compression fractures?
There is insufficient evidence to make recommendation for or against the use of vertebral augmentation to improve back pain in adults with osteoporotic vertebral compression fractures with or without intravertebral clefts in nonacute osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a retrospective comparative study, Ha et al1 investigated the clinical and radiological results of PVP in patients with OVCF with and without an intravertebral cleft. The authors concluded that “percutaneous vertebroplasty can be used to treat osteoporotic vertebral compression fractures with or without an intravertebral cleft. However, there is a greater likelihood of complications if an intravertebral cleft is present.” This paper provides Level III evidence that VP is a valuable option in patients with OVCF with or without intravertebral cleft with higher instance of cement-related complications in patients with clefts. References: 1. Ha KY, Lee JS, Kim KW, Chon JS. Percutaneous vertebroplasty for vertebral compression fractures with and without intravertebral clefts. J Bone Joint Surg Br. 2006;88:629-633.
FLASK Future Directions for Research
The work group recommends future prospective comparative studies with sufficient numbers to differentiate between outcomes with and without vertebral clefts. However, the work group recognizes it is not feasible to obtain Level I evidence to answer this question.
Interventional Treatment Question 8: Are there specific characteristics of the fracture or the patient that influence outcomes in patients with osteoporotic compression fractures undergoing vertebral augmentation?
Please note: In the answer to this question, the studies are quite diverse. The work group has chosen to make the following assumptions:
1) BMC, T-Score, and imaging assessments of bone density indicate the same general concept
2) A low T-Score is synonymous with low BMD
3) Cement leakage is an outcome, but does not appear to address the outcomes implied by the question
PATIENT FACTORS
It is suggested that decreased bone mineral density is associated with an increased risk of further fractures (new or recollapse) after vertebral augmentation of osteoporotic vertebral compression fractures. Grade of Recommendation: B
In a prospective comparative study, Liu et al1 investigated the risk factors of new vertebral compression fractured following a PVP in patients who had osteoporosis. The authors concluded that “The incidence of new VCFs after PV is relatively high and affected by several risk factors that are related to both the PV procedure and the natural course of osteoporosis.” This paper provides Level II evidence that the number of VCFs initially, CT value of nonfractured vertebrae, and activity level following discharge is strongly associated with the risk of new VCFs after PV.
In a prospective comparative study, Movrin et al2 assessed the adjacent level fracture risk after a BKP in comparison to a VP. Another aim of this study was to determine the possible dominant risk factor that is associated with new compression fractures. The authors concluded that “BK and VP are methods with a low risk of adjacent level fractures. The most important factors for new VCFs after a percutaneous augmentation procedure are the degree of osteoporosis and altered biomechanics in the treated area of the spine due to resistant kyphosis. These results suggest that the adjacent vertebrae would fracture eventually, even without the procedure. BK and VP offer a comparable rate of pain relief.” This paper provides Level II evidence that the degree of osteoporosis is a risk factor for new VCFs after percutaneous vertebral augmentation. In a prospective comparative study, Nieuwenhujse et al3 described the risk factors for new vertebral fractures, as well as estimate the fracture-free probabilities of multiple intact nontreated vertebrae given the patient- and vertebra-specific covariate status. The authors concluded that “New vertebral fractures after PVP were clustered within patients and depended heavily on the presence or absence of both patient- and vertebra-specific risk factors. Intradiskal cement leakage was a pronounced augmentation-related risk factor, for which a volumetric association was found.” This paper provides Level II evidence that patient level (low BMD, high spine deformity index, short-time since fracture onset) and vertebral-specific (thoracolumbar junction, close vicinity to the treated level) factors are associated with the development of new VCFs within 1-year after PVP. In a retrospective comparative study, Bae et al4 examined the risk factors for secondary new vertebral compression fractures (SNVCF) in patients with osteoporosis after they had undergone PVP. The authors concluded that “Poor bone mineral content can be a predictive factor of SNVCFs. To prevent SNVCFs, bone cement should be injected as evenly as possible into the vertebral body. Bone cement leakage into the disc space should be avoided.” This paper provides Level III evidence that patients developing SNVCF after PVP have lower bone mineral content (BMC) and cement leakage compared to those not developing SNVCF. In a retrospective comparative study, Chen et al5 investigated the risk factors that contributed to secondary vertebral compression fractures (SVCF) in patients who had undergone PVP or PKP due to an OVCF. The authors concluded that “older age and lower BMD were identified as risk factors of SVCF for OVCF patients following PVP/PKP surgery, whereas more ODA played a protective role in SVCF development.” This paper provides Level III evidence that increasing age is associated with higher likelihood of developing SVCF after PKP/PVP whereas higher BMD and higher outdoor activity is associated with decreased risk of developing fractures. In a retrospective comparative study, Gao et al6 studied the pre- and postoperative risk factors of the occurrence of short-term cement leakages, as well as long-term complications after PKP for OVCF. The authors concluded that “The presence of cortical disruption, large volume of cement, and low BMD of treated level are general but strong predictors for cement leakage. The presence of intravertebral cleft and Schmorl nodes are additional risk factors for cortical leakage. During follow-up, the occurrence of C-type leakage is a strong risk factor, for both new VCFs and recompression.” This paper provides Level III evidence that low BMD and cortical disruption are factors of cement leakage. Low BMD also associated with new VCF. IVC and Schmorl notes are respective risk factors for paravertebral type and c-type CL. In a retrospective comparative study, Hey et al7 assessed the relation between level-specific preoperative bone mineral density and subsequent vertebral fractures. Another aim of this study was to identify the factors that are associated with subsequent vertebral fractures. The authors concluded that “Level-specific T-scores are predictive of subsequent fractures and the odds ratio increases with lower T-scores from 2.2 or less to 2.6 or less. They have a low positive predictive value, but a high negative predictive value for subsequent fractures. Other significant associations with subsequent refractures include age and anterior vertebral height.” This paper provides Level III evidence that specific cutoffs of T-scores and age correlate with new fractures after vertebral augmentation procedures. In a prospective comparative study, Hiwatashi et al8 analyzed preoperative multidetector row CT (MDCT) in the prediction of subsequent fractures after PVP. The authors concluded that “The small size of the treated vertebrae may relate to subsequent fractures in adjacent vertebrae. Steroid use and low CT value of nonfractured vertebrae on preoperative MDCT can be associated with subsequent fractures in remote vertebrae.” The work group downgraded this potential Level II paper due to small sample size. This paper provides Level III Evidence that steroid use and low CT value are risk factors for new fractures in remote vertebrae while small vertebral size may be a risk for adjacent vertebral fractures. In a retrospective case-control study, Hu et al9 evaluated the factors that caused vertebral fractures after VP, as well as calculate the appropriate amount of bone cement to inject. The authors concluded that “Bone cement injection volume, BMD values, and sex were statistically significantly related to adjacent vertebral fractures after vertebroplasty, and cement injection volumes exceeding 40.5% caused adjacent vertebral fractures.” This paper provides Level III evidence that refractures after VP tend to occur more in females and those with lower BMD. In a retrospective comparative study, Huang et al10 examined the risk factors of vertebral new fractures after patients with primary osteoporotic thoracolumbar fractures had undergone PKP. The authors concluded that “Severe osteoporosis and bone cement leakage are risk factors of vertebral new fractures after PKP in patients with primary osteoporotic thoracolumbar fractures. Our findings suggest a requirement for anti-osteoporosis treatment after PKP operation for patients with primary osteoporotic thoracolumbar fractures.” This paper provides Level III evidence that osteoporosis and bone cement leakage are risk factors associated with new vertebra fractures post PKP. In a prospective comparative study, Komemushi et al11 assessed the relationship between biochemical marks of bone turnover, BMD, and new compression fractures following PVP. The authors concluded that “A combination of high levels of bone resorption markers and normal levels of bone formation markers may be associated with increased risk of new recurrent fractures after percutaneous vertebroplasty.” The work group downgraded this potential Level II paper due to no sample size, less than 80% follow-up, validated outcome measures not being used, and nonrandomization. This paper provides Level III evidence that high fracture risk patients (based on biochemical markers) have higher proportional of new fractures.
In a retrospective comparative study, Lee et al12 evaluated the risk factors for a SNVCF after a PVP is done to treat an OVCF. The authors concluded that “Low BMD, high preoperative compression ratio, and high preoperative SI may be predictive factors for SNVCFs. In particular, to prevent AVCF, the injected bone cement should be distributed both evenly and symmetrically along the inferior-to-superior axis and the relative bone cement volume should not be excessive. Bone cement should be injected carefully to avoid upper adjacent intradiscal leakage. Prompt BMD correction is important to prevent SNVCF.” This paper provides Level III evidence that in patients with single-level OVCF, a low BMD and high preop SI are associated with the risk of developing secondary NVCFs following PVP. In a retrospective comparative study, Li et al13 examined the incidence and potential causative factors of refracture in patients with OVCF who had undergone PVP or PKP. The authors found that low BMD, treatment by PKP vs vertebroplasty, and low cement volume potentially risk a recollapse of the treated vertebra. This paper provides Level III evidence that low BMD is a risk factor of vertebral recollapse after PKP/PVP. In a retrospective comparative study, Lin et al14 evaluated the characteristics of a recurrent fracture of a new vertebral body in patients with osteoporosis after having undergone PVP. The authors concluded that “A substantial number of patients with osteoporosis develop new fractures after vertebroplasty; two-thirds of these new fractures occur in vertebrae adjacent to those previously treated. The following variables influence the outcome: BMI, history of fractures, history of metabolic diseases and medications, BMD of lumbar spine and hip, anti-osteoporosis therapy, and use of back brace.” The work group downgraded this potential Level III paper due to low sample size and nonconsecutive patients. This paper provides Level IV evidence that patients developing new fractures after PV for OVCF differ significantly from those not developing new fractures in terms of BMI (low BMI vs controls), lower BMD and lower serum PTH levels. In a retrospective comparative study, Lu et al15 assessed the risk factors for subsequent vertebral compression fractures after undergoing PVP. The authors concluded that “The only risk factor significantly associated with subsequent vertebral compression fractures following percutaneous vertebroplasty was a low bone mineral density T-score. Patients with lower bone mineral density have a higher incidence of vertebral compression fractures and thus need more intensive clinical and radiological follow-up.” This paper provides Level III evidence that low T-scores (low BMD) are associated with the development of new VCFs after PV in patients with OVCF. In a retrospective comparative study, Sun et al16 aimed to identify the risk factors that are related to the development of subsequent fractures following VP. The authors concluded that “The most important risk factors affecting subsequent fractures after vertebroplasty were osteoporosis and treated level at the thoracolumbar junction.” This paper provides Level III evidence that low BMD and thoracolumbar location is associated with the development of subsequent new fractures in OVCF patients after VP. In a retrospective comparative study, Takahara et al17 analyzed the risk factors among several possible predictors for de novo vertebral fractures following percutaneous vertebroplasty in patients who had osteoporosis. The authors concluded that “advanced age and decreased lumbar and hip BMD scores most strongly indicated a risk of adjacent VF following PVP.” This paper provides Level III evidence that lower BMD and advancing age are significant risk factors associated with vertebral collapse after PVP in postmenopausal women. In a retrospective comparative study, Tseng et al18 evaluated the characteristics and risk factors of new-onset VCF following PVP. The authors concluded that “older patient age, lower baseline BMD, and more pre-existing vertebral fractures were found to be risk factors for multiple vertebral compression fractures.” This paper provides Level III evidence that patients experiencing 2 or more VCFs after initial PVP for OVCF tend to be relatively older, with lower baseline BMD, and have more pre-existing VCFs. In a retrospective comparative study, Wang et al19 assessed the incidence, risk factors, and possible causative mechanism of symptomatic AVF. Another aim of the study was to assess the intrinsic relationship between cement leakage into the disc and AVF. The authors concluded that “Older age, lower BMD, and intravertebral clefts are the main risk factors for symptomatic AVF after vertebral augmentation, but intradiscal cement leakage does not increase the risk of AVF. AVF occurs because of the natural progression of osteoporosis. Even distribution of bone cement in the vertebral body is important in OVCF patients with intravertebral clefts.” This paper provides Level III evidence that advancing age, lower BMD, and the presence of IVC is associated with the risk of AVF after PV in patients with OVCF. In a retrospective comparative study, Wu et al20 investigated the possible risk factors of secondary adjacent vertebral fractures after PKP in the treatment of OVCF. The authors concluded that “Fissure fracture, absence of systemic anti-osteoporosis therapy, leakage of bone cement into intervertebral disc, topical anesthesia and loss in bone density are high-risk factors of secondary adjacent vertebral fracture after PKP.” This paper provides Level III evidence that fracture type, use of antiosteoporotic treatment, and bone density are factors associated with the development of secondary AVF after PKP in OVCF patients. In a retrospective comparative study, Yang et al21 evaluated the risk factors and correlation of secondary adjacent vertebral compression fractures in percutaneous kyphoplasty. The authors concluded that “Patients with a lower bone mineral density value preoperative, larger balloon volume, cement volume, recovery rate of vertebral height and bone cement leakage intraoperative have an increased risk of adjacent vertebral compression fracture after percutaneous kyphoplasty.” This paper provides Level III evidence that patients incurring ACVF after PKP for OVCF have lower BMD. In a retrospective comparative study, Lin et al22 aimed to quantify symptomatic new VCF, as well as identify the risk factors for NSVCF in patients who had gone through percutaneous vertebroplasty. The authors concluded that “The most important risk factor affecting new VCFs is osteoporosis. The incidence of new symptomatic VCFs after PVP is higher in osteoporotic patients with lower BMD.” The work group downgraded this potential Level III paper due to nonconsecutive patients, nonrandomization, validated outcome measures not being used, and the diagnostic method not being stated. This paper provides Level IV evidence that lower BMD scores to be associated with increased risk of new VCF after PVP. In a retrospective comparative study, Li et al23 studied the risk factors for adjacent vertebral compression fractures following percutaneous vertebroplasty in patients with OVCF after going through menopause. The authors concluded that “A long duration of menopause and preoperative multi-level vertebral fractures were the risk factors for AVCF in patients following PVP after menopause, while a high-level BMD acted in a protective role for AVCF development.” The work group downgraded this potential Level III paper due to information that was lacking on the experimental study. This paper provides Level IV evidence that the duration of menopause and number of preop vertebral fractures are associated with an increased risk of AVCF after PVP. On the contrary, BMD was associated with lower risk of AVCF after PVP. In a retrospective comparative study, Lee et al24 examined the risk factors for newly developed OVCFs after vertebroplasty, kyphoplasty, or conservative treatment. The authors concluded that “Osteoporotic vertebral compression fracture patients with low BMD T-score of the lumbar spine and those who have been treated by cement augmentation have an increased risk of new OVCFs after treatment and, therefore, require especially careful observation and attention.” The work group downgraded this potential Level II paper due to less than 80% follow-up, nonconsecutive patients, and nonrandomization. This paper provides Level III evidence due to low BMD and VK/KP (with reference to conservative treatment) is associated with increased odds of development of new fractures. In a retrospective comparative study, Rho et al25 aimed to quantify symptomatic new vertebral compression fractures in patients who had undergone percutaneous vertebroplasty or percutaneous kyphoplasty, as well as evaluate the factors that would cause de novo fractures. The authors concluded that “The most important risk factors affecting NVCFs were osteoporosis and intervertebral discal cement leakage.” The work group downgraded this Level III paper due to nonconsecutive patients and nonrandomization. This paper provides Level IV evidence that osteoporosis (low BMD T-scores) is associated with new VCFs after vertebral augmentation.
Work Group Narrative: A majority of the evidence supported this recommendation, however there was one outlier, as it did not find a statistically significant effect on the occurrence of new vertebral fractures.
In a prospective randomized control trial study, Alhashash et al26 assessed the effect of bone cement viscosity and bone porosity on cement leakage during VP. Another purpose of this study was to analyze the occurrence of new vertebral fractures after vertebroplasty. The authors concluded that “The clinical outcome of vertebroplasty was not influenced by cement viscosity. However, lower cement viscosity and higher degree of osteoporosis were found to be significant risk factors for cement leakage. Furthermore, the number of vertebral body fractures on presentation was a predictor for the occurrence of new fractures postoperatively.” The work group downgraded this potential Level I paper due to nonconsecutive patients and a lack of robust applications, including adjusted regression analysis. This paper provides Level II evidence that the proportion of patients incurring cement leakage post-VP is higher in those with lower T-score and those injected with low-viscous cement and patients with multiple fractures at presentation (preop) were noted to have higher rates of new fractures postoperatively.
References: 1. Liu WG, He SC, Deng G, et al. Risk factors for new vertebral fractures after percutaneous vertebroplasty in patients with osteoporosis: a prospective study. J Vasc Interv Radiol. 2012;23(9):1143-1149. doi:10.1016/j.jvir.2012.06.019 2. Movrin I, Vengust R, Komadina R. Adjacent vertebral fractures after percutaneous vertebral augmentation of osteoporotic vertebral compression fracture: a comparison of balloon kyphoplasty and vertebroplasty. Arch Orthop Trauma Surg. 2010;130(9):1157-1166. doi:10.1007/s00402-010-1106-3 3. Nieuwenhuijse MJ, Putter H, van Erkel AR, Dijkstra PD. New vertebral fractures after percutaneous vertebroplasty for painful osteoporotic vertebral compression fractures: a clustered analysis and the relevance of intradiskal cement leakage. Radiology. 2013;266(3):862-870. 4. Bae JS, Park JH, Kim KJ, Kim HS, Jang IT. Analysis of Risk Factors for Secondary New Vertebral Compression Fracture Following Percutaneous Vertebroplasty in Patients with Osteoporosis. World Neurosurg. 2017;99:387-394. 5. Chen Z, Chen Z, Wu Y, et al. Risk Factors of Secondary Vertebral Compression Fracture After Percutaneous Vertebroplasty or Kyphoplasty: A Retrospective Study of 650 Patients. Med Sci Monit. 2019;25:9255-9261. doi:10.12659/MSM.915312. 6. Gao C, Zong M, Wang WT, Xu L, Cao D, Zou YF. Analysis of risk factors causing short-term cement leakages and long-term complications after percutaneous kyphoplasty for osteoporotic vertebral compression fractures. Acta Radiol. 2018;59(5):577-585. doi:10.1177/0284185117725368 7. Hey HW, Tan JH, Tan CS, Tan HM, Lau PH, Hee HT. Subsequent Vertebral Fractures Post Cement Augmentation of the Thoracolumbar Spine: Does it Correlate With Level-specific Bone Mineral Density Scores? [published correction appears in Spine (Phila Pa 1976). 2016 Feb;41(4):368. Hwee Weng, Dennis Hey [corrected to Hey, Hwee Weng Dennis]; Jun, Hao Tan [corrected to Tan, Jun Hao]; Chuen, Seng Tan [corrected to Tan, Chuen Seng]; Ming, Bryan Tan Hsi [corrected to Tan, Hsi Ming Bryan]; Huh, Bernard Lau Puang [corrected to Lau, Puang Hu]. Spine (Phila Pa 1976). 2015;40(24):1903-1909. doi:10.1097/BRS.0000000000001066 8. Hiwatashi A, Yoshiura T, Yamashita K, Kamano H, Dashjamts T, Honda H. Subsequent fracture after percutaneous vertebroplasty can be predicted on preoperative multidetector row CT. AJNR Am J Neuroradiol. 2009;30(10):1830-1834. doi:10.3174/ajnr.A1722 9. Hu L, Sun H, Wang H, et al. Cement injection and postoperative vertebral fractures during vertebroplasty. J Orthop Surg Res. 2019;14(1):228. doi:10.1186/s13018-019-1273-z 10. Huang ZF, Xia P, Liu K, Xiong W. Analysis of risk factors of new fracture of vertebral body after percutaneous kyphoplasty in patients with primary osteoporotic fracture of thoracic and lumbar spine. J Biomater Tissue Eng. 2018;8(5):756-759. 11. Komemushi A, Tanigawa N, Kariya S, et al. Biochemical markers of bone turnover in percutaneous vertebroplasty for osteoporotic compression fracture. Cardiovasc Intervent Radiol. 2008;31(2):332-335. doi:10.1007/s00270-007-9246-8. 12. Lee HJ, Park J, Lee IW, Yi JS, Kim T. Clinical, Radiographic, and Morphometric Risk Factors for Adjacent and Remote Vertebral Compression Fractures Over a Minimum Follow-up of 4 Years After Percutaneous Vertebroplasty for Osteoporotic Vertebral Compression Fractures: Novel Three-dimensional Voxel-Based Morphometric Analysis. World Neurosurg. 2019;125:e146-e157. doi:10.1016/j.wneu.2019.01.020 13. Li YX, Guo DQ, Zhang SC, et al. Risk factor analysis for re-collapse of cemented vertebrae after percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty (PKP). Int Orthop. 2018;42(9):2131-2139. doi:10.1007/s00264-018-3838-6 14. Lin H, Bao LH, Zhu XF, Qian C, Chen X, Han ZB. Analysis of recurrent fracture of a new vertebral body after percutaneous vertebroplasty in patients with osteoporosis. Orthop Surg. 2010;2(2):119-123. doi:10.1111/j.1757-7861.2010.00074.x 15. Lu K, Liang CL, Hsieh CH, Tsai YD, Chen HJ, Liliang PC. Risk factors of subsequent vertebral compression fractures after vertebroplasty. Pain Med. 2012;13(3):376-382. doi:10.1111/j.1526-4637.2011.01297.x 16. Sun G, Tang H, Li M, Liu X, Jin P, Li L. Analysis of risk factors of subsequent fractures after vertebroplasty. Eur Spine J. 2014;23(6):1339-1345. doi:10.1007/s00586-013-3110-0 17. Takahara K, Kamimura M, Moriya H, et al. Risk factors of adjacent vertebral collapse after percutaneous vertebroplasty for osteoporotic vertebral fracture in postmenopausal women. BMC Musculoskelet Disord. 2016;17:12. Published 2016 Jan 12. doi:10.1186/s12891-016-0887-0 18. Tseng YY, Yang TC, Tu PH, Lo YL, Yang ST. Repeated and multiple new vertebral compression fractures after percutaneous transpedicular vertebroplasty. Spine (Phila Pa 1976). 2009;34(18):1917-1922. doi:10.1097/BRS.0b013e3181ac8f07 19. Wang YT, Wu XT, Chen H, Wang C, Mao ZB. Adjacent-level symptomatic fracture after percutaneous vertebral augmentation of osteoporotic vertebral compression fracture: a retrospective analysis. J Orthop Sci. 2014;19(6):868-876. doi:10.1007/s00776-014-0610-7. 20. Wu J, Guan Y, Fan S. Analysis of risk factors of secondary adjacent vertebral fracture after percutaneous kyphoplasty. Biomedical Research (India). 2017;28(5):1956-1961. 21. Yang S, Liu Y, Yang H, Zou J. Risk factors and correlation of secondary adjacent vertebral compression fracture in percutaneous kyphoplasty. Int J Surg. 2016;36:138-142. 22. Lin Z, Du J, Lu C, Wang J. Risk factors of new symptomatic vertebral compression fractures after percutaneous vertebroplasty. Int J Clin Exp Med. 2019;12(1):949-954. 23. Li H, Yang DL, Ma L, Wang H, Ding WY, Yang SD. Risk Factors Associated with Adjacent Vertebral Compression Fracture Following Percutaneous Vertebroplasty After Menopause: A Retrospective Study. Med Sci Monit. 2017;23:5271-5276. Published 2017 Nov 5. doi:10.12659/msm.907364 24. Lee BG, Choi JH, Kim DY, Choi WR, Lee SG, Kang CN. Risk factors for newly developed osteoporotic vertebral compression fractures following treatment for osteoporotic vertebral compression fractures. Spine J. 2019;19(2):301-305. doi:10.1016/j.spinee.2018.06.347
25. Rho YJ, Choe WJ, Chun YI. Risk factors predicting the new symptomatic vertebral compression fractures after percutaneous vertebroplasty or kyphoplasty. Eur Spine J. 2012;21(5):905-911. doi:10.1007/s00586-011-2099-5 26. Alhashash M, Shousha M, Barakat AS, Boehm H. Effects of Polymethylmethacrylate Cement Viscosity and Bone Porosity on Cement Leakage and New Vertebral Fractures After Percutaneous Vertebroplasty: A Prospective Study. Global Spine J. 2019;9(7):754-760.
It is suggested that increasing age and female sex are associated with increased risk of further fractures (new or recollapse) after vertebral augmentation of osteoporotic vertebral compression fractures.
Grade of Recommendation: B
AGE:
In a prospective comparative study, Zhang et al1 investigated the relationship between handgrip strength (HGS) and the risk of a subsequent vertebral fracture (SVF) after percutaneous vertebral augmentation (PVA). The authors concluded that “Low HGS was significantly associated with lower SVF-free survival among elderly patients who underwent single-level PVA for osteoporotic vertebral fracture.” This paper provides Level II evidence that in both men and women, hand grip strength, older age, and lower BMI associated with higher risk of subsequent VF. In a retrospective comparative study, Bayram et al2 assessed whether central sarcopenia is associated with outcomes in patients with VCF, who were managed with PVA treatment. The authors concluded that “There is a significant correlation between sarcopenia and postoperative mortality after vertebral augmentation procedure in patients with VCFs.” This paper provides Level III evidence that increasing age, ASA score and sarcopenia (PLVI value) are associated with increased risk of mortality in patients with OVCF undergoing vertebral augmentation. In a retrospective comparative study, Chen et al3 evaluated the risk factors that contributed to secondary vertebral compression fractures (SVCF) in patients who had undergone PVP or PKP due to an OVCF. The authors concluded that “older age and lower BMD were identified as risk factors of SVCF for OVCF patients following PVP/PKP surgery, whereas more ODA played a protective role in SVCF development.” This paper provides Level III evidence that increasing age is associated with higher likelihood of developing SVCF after PKP/PVP whereas higher BMD and higher outdoor activity is associated with decreased risk of developing fractures. In a retrospective comparative study, Hey et al4 aimed to determine the relationship between level-specific preoperative BMD and subsequent vertebral fractures. Another aim of this study was to identify the factors that are associated with subsequent vertebral fractures. The authors concluded that “Level-specific T-scores are predictive of subsequent fractures and the odds ratio increases with lower T-scores from 2.2 or less to 2.6 or less. They have a low positive predictive value, but a high negative predictive value for subsequent fractures. Other significant associations with subsequent refractures include age and anterior vertebral height.” This paper provides Level III evidence that specific cutoffs of T-scores and age correlate with new fractures after vertebral augmentation procedures. In a retrospective comparative study, Takahara et al5 studied the risk factors among several possible predictors for de novo vertebral fractures following PVP in patients who had osteoporosis. The authors concluded that “advanced age and decreased lumbar and hip BMD scores most strongly indicated a risk of adjacent VF following PVP.” This paper provides Level III evidence that lower BMD and advancing age are significant risk factors associated with vertebral collapse after PVP in postmenopausal women. In a retrospective comparative study, Tseng et al6 evaluated the characteristics and risk factors of new-onset VCF following VP. The authors concluded that “older patient age, lower baseline BMD, and more pre-existing vertebral fractures were found to be risk factors for multiple vertebral compression fractures.” This paper provides Level III evidence that patients experiencing 2 or more VCFs after initial PVP for OVCF tend to be relatively older, with lower baseline BMD, and have more preexisting VCFs. In a retrospective comparative study, Wang et al7 examined the incidence, risk factors, and possible causative mechanism of symptomatic AVF. Another aim of the study was to assess the intrinsic relationship between cement leakage into the disc and AVF. The authors concluded that “Older age, lower BMD, and intravertebral clefts are the main risk factors for symptomatic AVF after vertebral augmentation, but intradiscal cement leakage does not increase the risk of AVF. AVF occurs because of the natural progression of osteoporosis. Even distribution of bone cement in the vertebral body is important in OVCF patients with intravertebral clefts.” This paper provides Level III evidence that advancing age, lower BMD, and the presence of IVC is associated with the risk of AVF after PV in patients with OVCF. In a retrospective comparative study, Lee et al8 analyzed the factors that affected new compression fractures in vertebral bodies that were adjacent to or remote from those who were previously treated with PVP. The authors concluded that “PVP done on multiple levels and older age patients increases the risk of developing new symptomatic vertebral compression fracture after PVP.” The work group downgraded this potential Level III paper due to nonrandomization, and less than 80% follow-up. This paper provides Level IV paper that when PVP is done on multiple levels on older patients, the risk of new symptomatic VCF is increased. FEMALE:
In a retrospective comparative study, Civelek et al9 evaluated the risk factors for new symptomatic VCF after having undergone BKP. The authors concluded that “If the patients experience severe or mild back pain with higher preoperative KA, especially in the first 2 months, then they deserve detailed radiologic examination. To avoid subsequent fracture in the same or adjacent level, vertebral body should be filled adequately and sagittal balance should be obtained with KA correction. BK alone did not influence the incidence of subsequent VCF.” This paper provides Level III evidence that female sex and higher preop KA have higher new symptomatic VCF after BK. In a retrospective case-control study, Hu et al10 assessed the factors that caused vertebral fractures after VP, as well as calculate the appropriate amount of bone cement to inject. The authors concluded that “Bone cement injection volume, BMD values, and sex were statistically significantly related to adjacent vertebral fractures after vertebroplasty, and cement injection volumes exceeding 40.5% caused adjacent vertebral fractures.” This paper provides Level III evidence that refractures after VP tend to occur more in females and those with lower BMD. In a retrospective comparative study, Moon et al11 investigated the incidence and influential factors of new VCF in women after having undergone kyphoplasty. The authors concluded that “When kyphoplasty is planned for the management of patients with osteoporotic VCFs, the application of a small amount of PMMA can be considered in order to lower the risk of new fractures in adjacent vertebrae. The post-operative use of anti-osteoporotic medication is recommended for the prevention of new VCFs.” This paper provides Level III evidence that female patients incurring new VCF after index kyphoplasty for OVCF have lower BMI and longer duration of symptoms compared to those not incurring new VCFs. References: 1. Zhang SB, Chen H, Xu HW, Yi YY, Wang SJ, Wu DS. Association between handgrip strength and subsequent vertebral-fracture risk following percutaneous vertebral augmentation. J Bone Miner Metab. 2021;39(2):186-192. doi:10.1007/s00774-020-01131-z 2. Bayram S, Akgul T, Adiyaman AE, Karalar S, Dolen D, Aydoseli A. Effect of Sarcopenia on Mortality after Percutaneous Vertebral Augmentation Treatment for Osteoporotic Vertebral Compression Fractures in Elderly Patients: A Retrospective Cohort Study. World Neurosurgery.138:e354-e360. 3. Chen Z, Chen Z, Wu Y, et al. Risk Factors of Secondary Vertebral Compression Fracture After Percutaneous Vertebroplasty or Kyphoplasty: A Retrospective Study of 650 Patients. Med Sci Monit. 2019;25:9255-9261. doi:10.12659/MSM.915312 4. Hey HW, Tan JH, Tan CS, Tan HM, Lau PH, Hee HT. Subsequent Vertebral Fractures Post Cement Augmentation of the Thoracolumbar Spine: Does it Correlate With Level-specific Bone Mineral Density Scores? [published correction appears in Spine (Phila Pa 1976). 2016 Feb;41(4):368. Hwee Weng, Dennis Hey [corrected to Hey, Hwee Weng Dennis]; Jun, Hao Tan [corrected to Tan, Jun Hao]; Chuen, Seng Tan [corrected to Tan, Chuen Seng]; Ming, Bryan Tan Hsi [corrected to Tan, Hsi Ming Bryan]; Huh, Bernard Lau Puang [corrected to Lau, Puang Hu]. Spine (Phila Pa 1976). 2015;40(24):1903-1909. doi:10.1097/BRS.0000000000001066 5. Takahara K, Kamimura M, Moriya H, et al. Risk factors of adjacent vertebral collapse after percutaneous vertebroplasty for osteoporotic vertebral fracture in postmenopausal women. BMC Musculoskelet Disord. 2016;17:12. doi:10.1186/s12891-016-0887-0 6. Tseng YY, Yang TC, Tu PH, Lo YL, Yang ST. Repeated and multiple new vertebral compression fractures after percutaneous transpedicular vertebroplasty. Spine (Phila Pa 1976). 2009;34(18):1917-1922. doi:10.1097/BRS.0b013e3181ac8f07 7. Wang YT, Wu XT, Chen H, Wang C, Mao ZB. Adjacent-level symptomatic fracture after percutaneous vertebral augmentation of osteoporotic vertebral compression fracture: a retrospective analysis. J Orthop Sci. 2014;19(6):868-876. doi:10.1007/s00776-014-0610-7. 8. Lee WS, Sung KH, Jeong HT, et al. Risk factors of developing new symptomatic vertebral compression fractures after percutaneous vertebroplasty in osteoporotic patients. Eur Spine J. 2006;15(12):1777-1783. doi:10.1007/s00586-006-0151-7 9. Civelek E, Cansever T, Yilmaz C, et al. The retrospective analysis of the effect of balloon kyphoplasty to the adjacent-segment fracture in 171 patients. J Spinal Disord Tech. 2014;27(2):98-104. doi:10.1097/bsd.0b013e31824e9b98 10. Hu L, Sun H, Wang H, et al. Cement injection and postoperative vertebral fractures during vertebroplasty. J Orthop Surg Res. 2019;14(1):228. doi:10.1186/s13018-019-1273-z 11. Moon ES, Kim HS, Park JO, et al. The incidence of new vertebral compression fractures in women after kyphoplasty and factors involved. Yonsei Med J. 2007;48(4):645-652. doi:10.3349/ymj.2007.48.4.645
It is suggested that multiple preexisting vertebral fractures are associated with increased risk of further fractures after vertebral augmentation of osteoporotic vertebral compression fractures.
Grade of Recommendation: B
In a prospective randomized control trial study, Alhashash et al1 studied the effect of bone cement viscosity and bone porosity on cement leakage during VP. Another purpose of this study was to analyze the occurrence of new vertebral fractures after VP. The authors concluded that “The clinical outcome of vertebroplasty was not influenced by cement viscosity. However, lower cement viscosity and higher degree of osteoporosis were found to be significant risk factors for cement leakage. Furthermore, the number of vertebral body fractures on presentation was a predictor for the occurrence of new fractures postoperatively.” The work group downgraded this potential Level I paper due to nonconsecutive patients and a lack of robust applications, including adjusted regression analysis. This paper provides Level II evidence that the proportion of patients incurring cement leakage post-VP is higher in those with lower T-score and those injected with low-viscous cement and patients with multiple fractures at presentation (preop) were noted to have higher rates of new fractures postoperatively. In a prospective comparative study, Liu et al2 evaluated the risk factors of new VCF following a PVP in patients who had osteoporosis. The authors concluded that “The incidence of new VCFs after PV is relatively high and affected by several risk factors that are related to both the PV procedure and the natural course of osteoporosis.” This paper provides Level II evidence that the number of VCFs initially, CT value of nonfractured vertebrae, and activity level following discharge is strongly associated with the risk of new VCFs after PV. In a prospective comparative study, Voormolen et al3 investigated the incidence, location, and potential causative mechanisms of new VCF in patients with OVCF treated with PVP. The authors concluded that “New VCFs occurred after PV in 24% of patients. Half of new VCFs occurred in levels adjacent to treated levels and half were symptomatic. The presence of more than two preexisting VCFs was the only independent risk factor for the development of a new VCF.” The work group downgraded this potential Level I paper due to less than 80% follow-up. This paper provides Level II evidence that the presence of multiple preexisting VCFs (3 or more) is a risk-factor for new VCF after PV. In a retrospective comparative study, Lee et al4 assessed the risk factors, prevention, and incidence of new vertebral compression fractures having undergoing percutaneous vertebroplasty. The authors concluded that “The most important elements related to reducing NVCF were treating osteoporosis and improving BMD and BMI. More aggressive BMD and BMI correction is more important than the vertebroplasty technique.” This paper provides Level III evidence that lower BMI and higher number of compression fractures are associated with a high risk of new VCF after vertebroplasty. In a retrospective comparative study, Ren et al5 aimed to determine the risk factors of new VCF in osteoporotic patients after undergoing PVP. The authors concluded that “The incidence of new symptomatic VCFs after PVP was higher in osteoporotic patients with initial multiple-level fractures.” This paper provides Level III evidence that a higher BMI and increase in number of initial VCFs are associated with increased risk of new VCFs after PVP. In a retrospective comparative study, Tseng et al6 examined the characteristics and risk factors of new-onset VCF following VP. The authors concluded that “older patient age, lower baseline BMD, and more pre-existing vertebral fractures were found to be risk factors for multiple vertebral compression fractures.” This paper provides Level III evidence that patients experiencing 2 or more VCFs after initial PVP for OVCF tend to be relatively older, with lower baseline BMD, and have more preexisting VCFs. In a retrospective comparative study, Li et al7 analyzed the risk factors for adjacent VCF following PVP in patients with OVCF after going through menopause. The authors concluded that “A long duration of menopause and preoperative multi-level vertebral fractures were the risk factors for AVCF in patients following PVP after menopause, while a high-level BMD acted in a protective role for AVCF development.” The work group downgraded this potential Level III paper due to information that was lacking on the experimental study. This paper provides Level IV evidence that the duration of menopause and number of preop vertebral fractures are associated with an increased risk of AVCF after PVP. On the contrary, BMD was associated with lower risk of AVCF after PVP. References: 1. Alhashash M, Shousha M, Barakat AS, Boehm H. Effects of Polymethylmethacrylate Cement Viscosity and Bone Porosity on Cement Leakage and New Vertebral Fractures After Percutaneous Vertebroplasty: A Prospective Study. Global Spine J. 2019;9(7):754-760. 2. Liu WG, He SC, Deng G, et al. Risk factors for new vertebral fractures after percutaneous vertebroplasty in patients with osteoporosis: a prospective study. J Vasc Interv Radiol. 2012;23(9):1143-1149. doi:10.1016/j.jvir.2012.06.019 3. Voormolen MH, Lohle PN, Juttmann JR, van der Graaf Y, Fransen H, Lampmann LE. The risk of new osteoporotic vertebral compression fractures in the year after percutaneous vertebroplasty. J Vasc Interv Radiol. 2006;17(1):71-76. 4. Lee DG, Park CK, Park CJ, Lee DC, Hwang JH. Analysis of Risk Factors Causing New Symptomatic Vertebral Compression Fractures After Percutaneous Vertebroplasty for Painful Osteoporotic Vertebral Compression Fractures: A 4-year Follow-up. J Spinal Disord Tech. 2015;28(10):E578-583. 5. Ren HL, Jiang JM, Chen JT, Wang JX. Risk factors of new symptomatic vertebral compression fractures in osteoporotic patients undergone percutaneous vertebroplasty. Eur Spine J. 2015;24(4):750-758. 6. Tseng YY, Yang TC, Tu PH, Lo YL, Yang ST. Repeated and multiple new vertebral compression fractures after percutaneous transpedicular vertebroplasty. Spine (Phila Pa 1976). 2009;34(18):1917-1922. doi:10.1097/BRS.0b013e3181ac8f07 7. Li H, Yang DL, Ma L, Wang H, Ding WY, Yang SD. Risk Factors Associated with Adjacent Vertebral Compression Fracture Following Percutaneous Vertebroplasty After Menopause: A Retrospective Study. Med Sci Monit. 2017; 23:5271-5276.
It is suggested that lower serum 25(OH)D levels are associated with increased risk of further fractures after vertebral augmentation of osteoporotic vertebral compression fractures.
Grade of Recommendation: B In a prospective randomized control trial study, Martinez-Ferrer et al1 aimed to describe the risk factors (clinical and radiological factors/densitometric and biochemical parameters) that were related to the development of vertebral fractures after undergoing percutaneous vertebroplasty. The authors concluded that “nearly 30% of patients with osteoporotic VF treated with VP presented a new VF after the procedure. Age, especially >80 years, and low vitamin D serum levels were related to the development of new VF in these patients, as were the number of vertebrae treated per patient and the presence of inferior disk cement leakage after the procedure.” The work group downgraded this potential Level I paper due to nonconsecutive patients and less than 80% follow-up. This paper provides Level II evidence that lower (deficient) 25 (OH)D levels is associated with increased risk of VCF after VP. In a prospective comparative study, Zafeiris et al2 evaluated the incidence of recurrent fractures after undergoing kyphoplasty, and determine whether the status of bone metabolism and 25-hydroxybitamin D (25(OH)D) levels would affect the occurrence of these fractures. The authors concluded that “Bone metabolism and 25(OH)D levels seem to play a role in the occurrence of postkyphoplasty recurrent vertebral compression fractures.” The work group downgraded this potential Level II paper due to nonconsecutive patients, nonmasked reviewers, nonmasked patients, nonrandomization, and small sample size. This paper provides Level III evidence that patients incurring new VCFs after maiden KP tend to have a lower vit D level compared to those not incurring fractures. References: 1. Martinez-Ferrer A, Blasco J, Carrasco JL, et al. Risk factors for the development of vertebral fractures after percutaneous vertebroplasty. J Bone Miner Res. 2013;28(8):1821-1829. doi:10.1002/jbmr.1899 2. Zafeiris CP, Lyritis GP, Papaioannou NA, et al. Hypovitaminosis D as a risk factor of subsequent vertebral fractures after kyphoplasty. Spine J. 2012;12(4):304-312. doi:10.1016/j.spinee.2012.02.016
It is suggested that lower BMI is associated with increased risk of further fractures after vertebral augmentation of osteoporotic vertebral compression fractures.
Grade of Recommendation: B In a prospective comparative study, Zhang et al1 aimed to find the relationship between handgrip strength (HGS) and the risk of a subsequent vertebral fracture (SVF) after percutaneous vertebral augmentation (PVA). The authors concluded that “Low HGS was significantly associated with lower SVF-free survival among elderly patients who underwent single-level PVA for osteoporotic vertebral fracture.” This paper provides Level II evidence that in both men and women, hand grip strength, older age, and lower BMI associated with higher risk of subsequent VF. In a retrospective comparative study, Lee et al2 assessed the risk factors, prevention, and incidence of new VCF undergoing PVP. The authors concluded that “The most important elements related to reducing NVCF were treating osteoporosis and improving BMD and BMI. More aggressive BMD and BMI correction is more important than the vertebroplasty technique.” This paper provides Level III evidence that lower BMI and higher number of compression fractures are associated with a high risk of new VCF after vertebroplasty. In a retrospective comparative study, Lin et al3 investigated the risk factors for new VCF following VP. The authors concluded that “New VCFs are common in patients with a low BMI, which suggests osteoporosis as a mechanism of fracture.” This paper provides Level III evidence that lower BMI (less than 22kg/m2) and greater kyphosis correction are associated with increased hazards of developing a new VCF in patients undergoing PV for single-level OVCF. In a retrospective comparative study, Moon et al4 evaluated the incidence and influential factors of new VCF in women after having undergone kyphoplasty. The authors concluded that “When kyphoplasty is planned for the management of patients with osteoporotic VCFs, the application of a small amount of PMMA can be considered in order to lower the risk of new fractures in adjacent vertebrae. The post-operative use of anti-osteoporotic medication is recommended for the prevention of new VCFs.” This paper provides Level III evidence that female patients incurring new VCF after index kyphoplasty for OVCF have lower BMI and longer duration of symptoms compared to those not incurring new VCFs. In a retrospective comparative study, Lin et al5 examined the characteristics of a recurrent fracture of a new vertebral body in patients with osteoporosis after having undergone PVP. The authors concluded that “A substantial number of patients with osteoporosis develop new fractures after vertebroplasty; two-thirds of these new fractures occur in vertebrae adjacent to those previously treated. The following variables influence the outcome: BMI, history of fractures, history of metabolic diseases and medications, BMD of lumbar spine and hip, anti-osteoporosis therapy, and use of back brace.” The work group downgraded this potential Level III paper due to low sample size and nonconsecutive patients. This paper provides Level IV evidence that patients developing new fractures after PV for OVCF differ significantly from those not developing new fractures in terms of BMI (low BMI vs controls), lower BMD and lower serum PTH levels. A retrospective comparative study, Ren et al6 analyzed the risk factors of new VCF in osteoporotic patients after undergoing percutaneous vertebroplasty. The authors concluded that “The incidence of new symptomatic VCFs after PVP was higher in osteoporotic patients with initial multiple-level fractures.” This paper provides Level III evidence that a higher BMI and increase in number of initial VCFs are associated with increased risk of new VCFs after PVP. Work Group Narrative: The majority of the evidence supports this recommendation, but considering that one article6 showed the opposite (higher BMI with increased initial OCVFs), more research is needed.
References: 1. Zhang SB, Chen H, Xu HW, Yi YY, Wang SJ, Wu DS. Association between handgrip strength and subsequent vertebral-fracture risk following percutaneous vertebral augmentation. J Bone Miner Metab. 2021;39(2):186-192. doi:10.1007/s00774-020-01131-z 2. Lee DG, Park CK, Park CJ, Lee DC, Hwang JH. Analysis of Risk Factors Causing New Symptomatic Vertebral Compression Fractures After Percutaneous Vertebroplasty for Painful Osteoporotic Vertebral Compression Fractures: A 4-year Follow-up. J Spinal Disord Tech. 2015;28(10):E578-583. 3. Lin WC, Cheng TT, Lee YC, et al. New vertebral osteoporotic compression fractures after percutaneous vertebroplasty: retrospective analysis of risk factors. J Vasc Interv Radiol. 2008;19(2 Pt 1):225-231. doi:10.1016/j.jvir.2007.09.008 4. Moon ES, Kim HS, Park JO, et al. The incidence of new vertebral compression fractures in women after kyphoplasty and factors involved. Yonsei Med J. 2007;48(4):645-652. doi:10.3349/ymj.2007.48.4.645 5. Lin H, Bao LH, Zhu XF, Qian C, Chen X, Han ZB. Analysis of recurrent fracture of a new vertebral body after percutaneous vertebroplasty in patients with osteoporosis. Orthop Surg. 2010;2(2):119-123. doi:10.1111/j.1757-7861.2010.00074.x 6. Ren HL, Jiang JM, Chen JT, Wang JX. Risk factors of new symptomatic vertebral compression fractures in osteoporotic patients undergone percutaneous vertebroplasty. Eur Spine J. 24(4):750-758.
Comorbidities may be considered as a factor in increased risk of further fractures after vertebral augmentation of osteoporotic vertebral compression fractures.
Grade of Recommendation: C Work Group Narrative: This is a grade C recommendation because there are not enough specific comorbidities identified in the papers available.
In a prospective comparative study, Deen et al1 analyzed the results of BKP in a group of organ transplant recipients, while also comparing VCF in transplant patients and patients with primary osteoporosis. The authors concluded that “balloon kyphoplasty can be performed safely in organ transplant recipients with VCFs. The degree of pain relief is equivalent to that seen in patients with primary osteoporosis. Results are durable at 12-month follow-up. Transplant patients developed earlier and more severe bony disease, with more severe baseline pain, a higher incidence of multiple fractures at the time of diagnosis, and a greater risk of new fracture development posttreatment, as compared with the primary osteoporosis group.” This paper provides Level II evidence that transplant patients have more severe bony disease, more severe baseline pain with higher incidence of multiple fractures at diagnosis. Although postop VAS, sagittal alignment improvement and narcotic analgesic usage may not differ across transplant and nontransplant patients, the former has higher risk of new fracture development post BKP. In a retrospective comparative study, Chen et al2 assessed the risk factors for cement leak and adjacent vertebral fracture in and after kyphoplasty for osteoporotic vertebral fractures. The authors concluded that “Diabetes and the alteration of the Cobb angle following PKP are factors positively related to the occurrence of postoperative adjacent vertebral fractures. It is also demonstrated that the integrity of vertebral walls and average volumes of injected cement are the possible risk factors of cement leakage while performing the PKP.” This paper provides Level III evidence that the incidence of postoperative adjacent vertebral fractures is higher in diabetics and altered Cobb angle (postsurgery). In a retrospective comparative study, Spross et al3 examined the incidence and possible risk factors of adjacent vertebral fractures with the SWISSpine (SSR) registry dataset. The authors concluded that “patients with a preoperative segmental kyphosis >30 degrees or patients with comorbidities like rheumatoid arthritis and a cardiovascular disease are at high risk of ASF within 6 months after the index surgery. In case of an ASF event, back pain levels are significantly increased.” This paper provides Level III evidence that a preop kyphotic angle of over 30°, and patient-specific comorbidities (such as RA, cardiovascular disease) are significantly associated with the risk of new adjacent segment fracture (ASF) after BKP. References: 1. Deen HG, Aranda-Michel J, Reimer R, Miller DA, Putzke JD. Balloon kyphoplasty for vertebral compression fractures in solid organ transplant recipients: results of treatment and comparison with primary osteoporotic vertebral compression fractures. Spine J. 2006;6(5):494-499. doi:10.1016/j.spinee.2006.01.011 2. Chen C, Fan P, Xie X, Wang Y. Risk Factors for Cement Leakage and Adjacent Vertebral Fractures in Kyphoplasty for Osteoporotic Vertebral Fractures. Clin Spine Surg. 2020;33(6):E251-E255. doi:10.1097/BSD.0000000000000928 3. Spross C, Aghayev E, Kocher R, Röder C, Forster T, Kuelling FA. Incidence and risk factors for early adjacent vertebral fractures after balloon kyphoplasty for osteoporotic fractures: analysis of the SWISSspine registry. Eur Spine J. 2014;23(6):1332-1338. doi:10.1007/s00586-013-3052-6.
There is insufficient evidence to make a recommendation for or against the use of various biomedical markers as risk factors for further fractures after vertebral augmentation of osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a prospective comparative study, Komemushi et al1 assessed the relationship between biochemical marks of bone turnover, BMD, and new compression fractures following PVP. The authors concluded that “A combination of high levels of bone resorption markers and normal levels of bone formation markers may be associated with increased risk of new recurrent fractures after percutaneous vertebroplasty.” The work group downgraded this potential Level II paper due to small sample size, less than 80% follow-up, validated outcome measures not being used, and nonrandomization. This paper provides Level III evidence that high fracture risk patients (based on biochemical markers) have higher proportional of new fractures. References: 1. Komemushi A, Tanigawa N, Kariya S, et al. Biochemical markers of bone turnover in percutaneous vertebroplasty for osteoporotic compression fracture. Cardiovasc Intervent Radiol. 2008;31(2):332-335. doi:10.1007/s00270-007-9246-8.
There is insufficient evidence to make a recommendation for or against the effect of long-term steroid use on the outcome of vertebral augmentation for osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a retrospective comparative study, Hiwatashi et al1 aimed to determine the characteristics of patients with new fractures following VP. The authors concluded that “Patients who are on long-term steroid medication have an elevated risk of developing new fractures after vertebroplasty.” This paper provides Level III evidence that in patients with osteoporotic compression fractures, a higher proportion of patients developing new fractures after PVP are those on long-term steroid medications. In a prospective comparative study, Hiwatashi et al2 evaluated preoperative multidetector row CT (MDCT) in the prediction of subsequent fractures after PVP. The authors concluded that “The small size of the treated vertebrae may relate to subsequent fractures in adjacent vertebrae. Steroid use and low CT value of nonfractured vertebrae on preoperative MDCT can be associated with subsequent fractures in remote vertebrae.” The work group downgraded this potential Level II paper due to small sample size. This paper provides Level III evidence that steroid use and low CT value are risk factors for new fractures in remote vertebrae while small vertebral size may be a risk for adjacent vertebral fractures. In a retrospective case control study, Koch et al3 compared the effectiveness and complication rate in patients undergoing PVP to treat VCF as a result of secondary osteoporosis, in relation to patients with primary osteoporosis who were treated with PVP. The authors concluded that “Percutaneous vertebroplasty performed for vertebral compression fractures as a result of long-term corticosteroid therapy is as safe and effective in relieving pain as PVP performed in patients with vertebral compression fractures as a result of primary osteoporosis.” This paper provides Level III evidence that steroid use is not a significant predictor of poor outcomes, specific to complication rates and development of new fractures. References: 1. Hiwatashi A, Westesson PL. Patients with osteoporosis on steroid medication tend to sustain subsequent fractures. Am J Neuroradiol. 2007;28:1055–1057 2. Hiwatashi A, Yoshiura T, Yamashita K, Kamano H, Dashjamts T, Honda H. Subsequent fracture after percutaneous vertebroplasty can be predicted on preoperative multidetector row CT. AJNR Am J Neuroradiol. 2009;30(10):1830-1834. doi:10.3174/ajnr.A1722 3. Koch CA, Layton KF, Kallmes DF. Outcomes of patients receiving long-term corticosteroid therapy who undergo percutaneous vertebroplasty. AJNR Am J Neuroradiol. 2007;28(3):563-566.
There is insufficient evidence to make a recommendation for or against the impact of high preop sacral inclination and high spinal deformity Index in evaluating risk of further fractures after vertebral augmentation of osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a prospective comparative study, Nieuwenhujse et al1 investigated the risk factors for new vertebral fractures, as well as estimate the fracture-free probabilities of multiple intact nontreated vertebrae given the patient- and vertebra-specific covariate status. The authors concluded that “New vertebral fractures after PVP were clustered within patients and depended heavily on the presence or absence of both patient- and vertebra-specific risk factors. Intradiskal cement leakage was a pronounced augmentation-related risk factor, for which a volumetric association was found.” This paper provides Level II evidence that patient level (low BMD, high spine deformity index, short-time since fracture onset) and vertebral-specific (thoracolumbar junction, close vicinity to the treated level) factors are associated with the development of new VCFs within one-year after PVP. In a retrospective comparative study, Lee et al2 studied the risk factors for a SNVCF after a PVP is done to treat an OVCF. The authors concluded that “Low BMD, high preoperative compression ratio, and high preoperative SI may be predictive factors for SNVCFs. In particular, to prevent AVCF, the injected bone cement should be distributed both evenly and symmetrically along the inferior-to-superior axis and the relative bone cement volume should not be excessive. Bone cement should be injected carefully to avoid upper adjacent intradiscal leakage. Prompt BMD correction is important to prevent SNVCF.” This paper provides Level III evidence that in patients with single-level OVCF, a low BMD and high preop SI are associated with the risk of developing secondary NVCFs following PVP. References: 1. Nieuwenhuijse MJ, Putter H, van Erkel AR, Dijkstra PD. New vertebral fractures after percutaneous vertebroplasty for painful osteoporotic vertebral compression fractures: a clustered analysis and the relevance of intradiskal cement leakage. Radiology. 2013;266(3):862-870. 2. Lee HJ, Park J, Lee IW, Yi JS, Kim T. Clinical, Radiographic, and Morphometric Risk Factors for Adjacent and Remote Vertebral Compression Fractures Over a Minimum Follow-up of 4 Years After Percutaneous Vertebroplasty for Osteoporotic Vertebral Compression Fractures: Novel Three-dimensional Voxel-Based Morphometric Analysis. World Neurosurg. 2019;125:e146-e157. doi:10.1016/j.wneu.2019.01.020
There is insufficient evidence to make a recommendation for or against the impact of activity level in evaluating risk of further fractures after vertebral augmentation of osteoporotic vertebral compression fractures.
Grade of Recommendation: I
n a prospective comparative study, Liu et al1 examined the risk factors of new VCF following a PVP in patients who had osteoporosis. The authors concluded that “The incidence of new VCFs after PV is relatively high and affected by several risk factors that are related to both the PV procedure and the natural course of osteoporosis.” This paper provides Level II evidence that the number of VCFs initially, CT value of nonfractured vertebrae, and activity level following discharge is strongly associated with the risk of new VCFs after PV. In a retrospective comparative study, Chen et al2 analyzed the risk factors that contributed to SVCF in patients who had undergone PVP or PKP due to an OVCF. The authors concluded that “older age and lower BMD were identified as risk factors of SVCF for OVCF patients following PVP/PKP surgery, whereas more ODA played a protective role in SVCF development.” This paper provides Level III evidence that increasing age is associated with higher likelihood of developing SVCF after PKP/PVP whereas higher BMD and higher outdoor activity is associated with decreased risk of developing fractures. References: 1. Liu WG, He SC, Deng G, et al. Risk factors for new vertebral fractures after percutaneous vertebroplasty in patients with osteoporosis: a prospective study. J Vasc Interv Radiol. 2012;23(9):1143-1149. doi:10.1016/j.jvir.2012.06.019 2. Chen Z, Chen Z, Wu Y, et al. Risk Factors of Secondary Vertebral Compression Fracture After Percutaneous Vertebroplasty or Kyphoplasty: A Retrospective Study of 650 Patients. Med Sci Monit. 2019;25:9255-9261. doi:10.12659/MSM.915312
There is insufficient evidence to make a recommendation for or against the impact of ASA score in predicting VAS scores after vertebral augmentation of osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a retrospective comparative study, Bayram et al1 assessed whether central sarcopenia is associated with outcomes in patients with VCF, who were managed with percutaneous vertebral augmentation treatment. The authors concluded that “There is a significant correlation between sarcopenia and postoperative mortality after vertebral augmentation procedure in patients with VCFs.” This paper provides Level III evidence that increasing age, ASA score and sarcopenia (PLVI value) are associated with increased risk of mortality in patients with OVCF undergoing vertebral augmentation. References: 1. Bayram S, Akgul T, Adiyaman AE, Karalar S, Dolen D, Aydoseli A. Effect of Sarcopenia on Mortality after Percutaneous Vertebral Augmentation Treatment for Osteoporotic Vertebral Compression Fractures in Elderly Patients: A Retrospective Cohort Study. World Neurosurgery. 2020;138:e354-e360.
FRACTURE FACTORS
It is suggested that intravertebral cleft (IVC) is associated with poor outcomes after vertebral augmentation of osteoporotic vertebral compression fractures.
Grade of Recommendation: B
In a retrospective comparative study, Denoix et al1 aimed to determine the predictive factors for mid-term outcome following VP for osteoporotic fractures with persistent pain. The authors concluded that “In patients with persistent and intense pain after an osteoporotic vertebral fracture, early intervention and absence of intravertebral cleft were predictors of favourable outcome at 1 month after vertebroplasty.” This paper provides Level III evidence that early intervention (within 2-months after fracture) and absent IVC on preop imaging increases the likelihood of a favorable outcome as assessed within one-month postop.
In a retrospective comparative study, Gao et al2 assessed the pre- and postoperative risk factors of the occurrence of short-term cement leakages, as well as long-term complications after percutaneous kyphoplasty for OVCF. The authors concluded that “The presence of cortical disruption, large volume of cement, and low BMD of treated level are general but strong predictors for cement leakage. The presence of intravertebral cleft and Schmorl nodes are additional risk factors for cortical leakage. During follow-up, the occurrence of C-type leakage is a strong risk factor, for both new VCFs and recompression.” This paper provides Level III evidence that low BMD and cortical disruption are factors of cement leakage. Low BMD also associated with new VCF. IVC and Schmorl nodes are respective risk factors for paravertebral type and c-type CL.
In a retrospective comparative study, Ha et al3 aimed to differentiate the clinical and radiological outcomes of PVP in patients with OVCF with or without intravertebral cleft. The authors concluded that “percutaneous vertebroplasty can be used to treat osteoporotic vertebral compression fractures with or without an intravertebral cleft. However, there is a greater likelihood of complications if an intravertebral cleft is present.” This paper provides Level III evidence that The presence of intravertebral cleft is associated with higher ODI, VAS scores, and higher rates of complications compared to those without clefts.
In a retrospective comparative study, Kim et al4 described the factors that affect recompression of operated vertebrae following BKP for OVCF. The authors concluded that “IVC and NPEC may be important factors related to inducing recompression of previously treated vertebrae after PKP. This recompression may cause operated vertebrae to return to their preoperative condition and may worsen clinical symptoms due to pain or the development of spinal deformities.” This paper provides Level III evidence that patients incurring recompression after PKP have high proportion of IVC (100% VS 10%; P<0.05) and non-PMMA-endplate-contact (NPEC). In a retrospective comparative study, Nakamae et al5 evaluated the outcomes of PVP in patients who had single-level osteoporotic vertebral fractures with intravertebral cleft, as well as identify the risk factors for cement loosing from the treatment. The authors concluded that “Patients with cement loosening experienced worse back pain than those without cement loosening. The important risk factors that influenced cement loosening after PVP were high intravertebral instability, Parkinson’s disease, spinous process fracture, and split vertebrae.” This paper provides Level III evidence that patients with single-level OVCF with IVC incurring cement loosening after PVP have significantly higher mean VAS scores compared to those without cement loosening. In a retrospective comparative study, Trout et al6 investigated the possible adverse consequences of VP in the setting of intraosseous clefts, specifically with an incidence of subsequent vertebral fractures. The authors concluded that “Patients with osteoporotic vertebral fractures containing clefts are at increased risk for subsequent fractures and treatment of these clefts is associated with increased rates of adjacent fracture. There is no significant difference in the timing of subsequent fractures based on the presence of a cleft.” This paper provides Level III evidence that the presence of IVC is associated with the increased risk of subsequent fractures in OVCF patients after VP. In a retrospective comparative study, Wang et al7 studied the incidence, risk factors, and possible causative mechanism of symptomatic AVF. Another aim of the study was to assess the intrinsic relationship between cement leakage into the disc and AVF. The authors concluded that “Older age, lower BMD, and intravertebral clefts are the main risk factors for symptomatic AVF after vertebral augmentation, but intradiscal cement leakage does not increase the risk of AVF. AVF occurs because of the natural progression of osteoporosis. Even distribution of bone cement in the vertebral body is important in OVCF patients with intravertebral clefts.” This paper provides Level III evidence that advancing age, lower BMD, and the presence of IVC is associated with the risk of AVF after PV in patients with OVCF. In a retrospective comparative study, Li et al8 examined the risk factors and incidence of residual back pain in patients with OVCF after having undergone PKP treatment. The authors concluded that “The incidence of postoperative residual back pain was 7.8% among 809 OVCF patients following PKP. The presence of an intravertebral vacuum cleft, posterior fascia oedema, facet joint violations and a separated cement distribution were identified as independent risk factors for residual back pain.” The work group downgraded this potential Level III paper due to nonrandomization. This paper provides Level IV evidence that IVC and posterior fascia edema are fracture-specific risk factors associated with increased likelihood of residual back pain after PKP. References: 1. Denoix E, Viry F, Ostertag A, et al. What are the predictors of clinical success after percutaneous vertebroplasty for osteoporotic vertebral fractures? Eur Radiol. 2018;28(7):2735-2742. doi:10.1007/s00330-017-5274-1 2. Gao C, Zong M, Wang WT, Xu L, Cao D, Zou YF. Analysis of risk factors causing short-term cement leakages and long-term complications after percutaneous kyphoplasty for osteoporotic vertebral compression fractures. Acta Radiol. 2018;59(5):577-585. doi:10.1177/0284185117725368 3. Ha KY, Lee JS, Kim KW, Chon JS. Percutaneous vertebroplasty for vertebral compression fractures with and without intravertebral clefts. J Bone Joint Surg Br. 2006;88:629-633. 4. Kim YY, Rhyu KW. Recompression of vertebral body after balloon kyphoplasty for osteoporotic vertebral compression fracture. Eur Spine J. 2010;19(11):1907-1912. doi:10.1007/s00586-010-1479-6 5. Nakamae T, Yamada K, Tsuchida Y, Osti OL, Adachi N, Fujimoto Y. Risk Factors for Cement Loosening after Vertebroplasty for Osteoporotic Vertebral Fracture with Intravertebral Cleft: A Retrospective Analysis. Asian Spine J. 2018;12(5):935-942. doi:10.31616/asj.2018.12.5.935 6. Trout AT, Kallmes DF, Lane JI, Layton KF, Marx WF. Subsequent vertebral fractures after vertebroplasty: association with intraosseous clefts. AJNR Am J Neuroradiol. 2006;27(7):1586-1591. 7. Wang YT, Wu XT, Chen H, Wang C, Mao ZB. Adjacent-level symptomatic fracture after percutaneous vertebral augmentation of osteoporotic vertebral compression fracture: a retrospective analysis. J Orthop Sci. 2014;19(6):868-876. doi:10.1007/s00776-014-0610-7. 8. Li Y, Yue J, Huang M, et al. Risk factors for postoperative residual back pain after percutaneous kyphoplasty for osteoporotic vertebral compression fractures. Eur Spine J. 2020;29(10):2568-2575. doi:10.1007/s00586-020-06493-6
It is suggested that higher preoperative kyphotic angle is associated with inferior/poor outcomes, such as new vertebral compression fractures and VAS/RMDQ scores, after vertebral augmentation of osteoporotic vertebral compression fractures.
Grade of Recommendation: B
In a retrospective case control study, Borensztein et al1 compared the technical and epidemiological variables in patients who had new VCF following PVP in relation to a control group. The authors concluded that “increased cement percentage injected and a higher kyphosis were associated with new vertebral compression fractures.” This paper provides Level III evidence that higher segmental kyphotic angle and cement volume are associated with development of new VCFs within 1-year after index VP. In a retrospective comparative study, Civelek et al2 analyzed the risk factors for new symptomatic VCF after having undergone BKP. The authors concluded that “If the patients experience severe or mild back pain with higher preoperative KA, especially in the first 2 months, then they deserve detailed radiologic examination. To avoid subsequent fracture in the same or adjacent level, vertebral body should be filled adequately and sagittal balance should be obtained with KA correction. BK alone did not influence the incidence of subsequent VCF.” This paper provides Level III evidence that female sex and higher preop KA have higher new symptomatic VCF after BK. In a retrospective comparative study, Kang et al3 aimed to determine the risk factors for the development of a vertebral refracture following a PVP. The authors concluded that “Patients who had a high preoperative local kyphotic angle and a high sagittal index required a close follow-up and attention.” This paper provides Level III evidence that in patients with osteoporotic compression fractures, differences in local KA and sagittal index are statistically significant factors for the risk of refracture in patients undergoing percutaneous vertebroplasty. In a prospective comparative study, Khurjekar et al4 assessed the relationship between kyphosis and wedge angles with pain relief and functional outcomes following PVP. The authors concluded that “PV is a viable treatment for vertebral compression fractures with regard to pain relief and improvement of function. Preoperative kyphosis and wedge angles were predictive of post-PV outcomes in terms of VAS and RMDQ scores.” The work group downgraded this potential Level II paper due to nonconsecutive patients, nonrandomization, and small sample size. This paper provides Level III evidence that preop kyphosis and wedge angles correlate with postop outcomes (better VAS and RMDQ scores). In a retrospective comparative study, Spross et al5 aimed to identify the incidence and possible risk factors of adjacent vertebral fractures with the SWISSpine (SSR) registry dataset. The authors concluded that “patients with a preoperative segmental kyphosis >30 degrees or patients with comorbidities like rheumatoid arthritis and a cardiovascular disease are at high risk of ASF within 6 months after the index surgery. In case of an ASF event, back pain levels are significantly increased.” This paper provides Level III evidence that a preop kyphotic angle of over 30°, and patient-specific comorbidities (such as RA, cardiovascular disease) are significantly associated with the risk of new adjacent segment fracture (ASF) after BKP.
References: 1. Borensztein M, Camino Willhuber GO, Posadas Martinez ML, Gruenberg M, Sola CA, Velan O. Analysis of Risk Factors for New Vertebral Fracture After Percutaneous Vertebroplasty. Global Spine J. 2018;8(5):446-452. doi:10.1177/2192568217732988 2. Civelek E, Cansever T, Yilmaz C, et al. The retrospective analysis of the effect of balloon kyphoplasty to the adjacent-segment fracture in 171 patients. J Spinal Disord Tech. 2014;27(2):98-104. doi:10.1097/bsd.0b013e31824e9b98 3. Kang S, Lee CW, Park NK, Kang T, Lim J, Cha KY, Kim JH (2011) Predictive risk factors for refracture after percutaneous vertebroplasty. Ann Rehabil Med 35:844–851 4. Khurjekar K, Shyam AK, Sancheti PK, Sonawane D. Correlation of kyphosis and wedge angles with outcome after percutaneous vertebroplasty: a prospective cohort study. J Orthop Surg (Hong Kong). 2011;19(1):35-40. doi:10.1177/230949901101900108 5. Spross C, Aghayev E, Kocher R, Röder C, Forster T, Kuelling FA. Incidence and risk factors for early adjacent vertebral fractures after balloon kyphoplasty for osteoporotic fractures: analysis of the SWISSspine registry. Eur Spine J. 2014;23(6):1332-1338. doi:10.1007/s00586-013-3052-6.
It is suggested that vertebral compression fractures located in the thoracolumbar junction are associated with a higher risk of new vertebral compression fractures, and also have progressive kyphosis and neurological complications after vertebral augmentation of osteoporotic vertebral compression fractures.
Grade of Recommendation: B
In a prospective comparative study, Nieuwenhujse et al1 evaluated the risk factors for new vertebral fractures, as well as estimate the fracture-free probabilities of multiple intact nontreated vertebrae given the patient- and vertebra-specific covariate status. The authors concluded that “New vertebral fractures after PVP were clustered within patients and depended heavily on the presence or absence of both patient- and vertebra-specific risk factors. Intradiscal cement leakage was a pronounced augmentation-related risk factor, for which a volumetric association was found.” This paper provides Level II evidence that patient level (low BMD, high spine deformity index, short-time since fracture onset) and vertebral-specific (thoracolumbar junction, close vicinity to the treated level) factors are associated with the development of new VCFs within 1-year after PVP. In a retrospective comparative study, Chou et al2 investigated the relevant incidence and risk factors of delayed vertebral collapse and progressive kyphosis with spinal canal encroachment following vertebroplasty for the treatment of a vertebral compression fracture. The authors concluded that “Conservative treatment and minimal invasive vertebral augmentation surgery can be selected from patients with stable VCFs.” This paper provides Level III evidence that fracture location (TL junction) and type (IVC or wedge) and material injected (nonintegration properties) are risk factors for development of progressive kyphosis and neurological complications post-VP. In a retrospective comparative study, Lee et al3 described the risk factors and incidence in relation to adjacent vertebral fractures following PVP to treat OVCF. The authors concluded that “Intradiscal cement leakage does not seem to be related to subsequent adjacent vertebral compression fracture in patients who underwent PVP for treatment of an osteoporotic compression fracture. The thoracolumbar location of the initial compression fracture is the only factor correlated with an adjacent vertebral fracture after PVP.” This paper provides Level III evidence that initial fracture location in the thoracolumbar region is associated with the development of adjacent vertebral fracture after PVP.
In a retrospective comparative study, Sun et al4 examined the risk factors that are related to the development of subsequent fractures following vertebroplasty. The authors concluded that “The most important risk factors affecting subsequent fractures after vertebroplasty were osteoporosis and treated level at the thoracolumbar junction.” This paper provides Level III evidence that low BMD and thoracolumbar location is associated with the development of subsequent new fractures in OVCF patients after VP. References: 1. Nieuwenhuijse MJ, Putter H, van Erkel AR, Dijkstra PD. New vertebral fractures after percutaneous vertebroplasty for painful osteoporotic vertebral compression fractures: a clustered analysis and the relevance of intradiskal cement leakage. Radiology. 2013;266(3):862-870. 2. Chou KN, Lin BJ, Wu YC, Liu MY, Hueng DY. Progressive kyphosis after vertebroplasty in osteoporotic vertebral compression fracture. Spine (Phila Pa 1976). 2014;39(1):68-73. doi:10.1097/BRS.0000000000000042 3. Lee KA, Hong SJ, Lee S, Cha IH, Kim BH, Kang EY. Analysis of adjacent fracture after percutaneous vertebroplasty: does intradiscal cement leakage really increase the risk of adjacent vertebral fracture?. Skeletal Radiol. 2011;40(12):1537-1542. doi:10.1007/s00256-011-1139-x 4. Sun G, Tang H, Li M, Liu X, Jin P, Li L. Analysis of risk factors of subsequent fractures after vertebroplasty. Eur Spine J. 2014;23(6):1339-1345. doi:10.1007/s00586-013-3110-0
It is suggested that a greater degree of vertebral body edema on preoperative MRI is associated with better outcomes in patients treated with vertebral augmentation for osteoporotic vertebral compression fractures.
Grade of Recommendation: B
In a retrospective comparative study, Grafe et al1 studied the clinical and radiomorphological outcomes following kyphoplasty to treat OVCF with and without preoperative MR-detectable bone marrow edema. The authors concluded that “A preoperative MR-detectable vertebral bone marrow edema predicts a better short-term outcome after kyphoplasty, but is not a prerequisite for long-term pain reduction in patients with old, chronically painful osteoporotic vertebral fractures.” This paper provides Level III evidence that patients with preop vertebral body edema had relatively better pain control in the immediate postop (along with greater VH restoration and KA correction) compared to those without edema. In a prospective observational study, Lin Xu et al2 analyzed the MRI to predict further collapse and vertebral height loss following VP. The authors concluded that “Although vertebroplasty can initially stabilize injured vertebrae, further collapse of the cemented vertebrae occurred rapidly during follow-up. In this study, significant pre-procedure MRI-based predictors of increased risk for cemented vertebral refracture have been identified.” This paper provides Level III evidence that in patients with OVCF undergoing vertebral augmentation, higher signal intensity on T2 MRI-weighted images are associated with less refractures. In a prospective observational study, Xu et al3 aimed to determine the correlation between MRI characteristics of OVCF and the effectiveness of PVP. The authors concluded “PVP is an effective treatment for OVCFs. Better outcomes were observed among patients with severe or moderate bone marrow edema rather than those with mild bone marrow edema. A greater degree of pain relief after PVP was correlated with faster recovery of the postoperative function. However, this correlation gradually became weak over time and disappeared 6 months after surgery. Therefore, PVP should be an option for early stage OVCFs, especially among patients with bone marrow edema signs on MRI.” This paper provides Level III evidence that in patients with OVCF, patients with moderate or severe edema in the MRI pre op have better outcomes compares to patients with mild edema undergoing percutaneous vertebroplasty. References: 1. Grafe IA, Nöldge G, Weiss C, et al. Prediction of immediate and long-term benefit after kyphoplasty of painful osteoporotic vertebral fractures by preoperative MRI. Eur J Trauma Emerg Surg. 2011;37(4):379-386. doi:10.1007/s00068-010-0050-9. 2. Lin WC, Lu CH, Chen HL, Wang HC, Yu CY, Wu RW, et al. The impact of preoperative magnetic resonance images on outcome of cemented vertebrae. Eur Spine J. 2010;19:1899-1906. 3. Xu W, Wang S, Chen C, et al. Correlation analysis between the magnetic resonance imaging characteristics of osteoporotic vertebral compression fractures and the efficacy of percutaneous vertebroplasty: a prospective cohort study. BMC Musculoskeletal Disorders. 2018;19(1):114
There is insufficient evidence to make a recommendation for or against type of fracture or shape as a risk factor for progressive kyphosis and secondary AVF in patients with osteoporotic vertebral compression fractures underdoing vertebral augmentation.
Grade of Recommendation: I
In a retrospective comparative study, Chou et al1 evaluated the relevant incidence and risk factors of delayed vertebral collapse and progressive kyphosis with spinal canal encroachment following VP for the treatment of a VCF. The authors concluded that “Conservative treatment and minimal invasive vertebral augmentation surgery can be selected from patients with stable VCFs.” This paper provides Level III evidence that fracture location (TL junction) and TYPE (IVC or wedge) and material injected (nonintegration properties) are risk factors for development of progressive kyphosis and neurological complications post-VP. In a retrospective comparative study, De Kong et al2 assessed the impact of shape and severity of osteoporotic vertebral fractures on the surgical and clinical outcomes of kyphoplasty treatment. The authors concluded that “assessing the shape and severity of fractured osteoporotic vertebrae gives an idea of the potential correction of body height and kyphosis, and of the risk of cement leakage.” This paper provides Level III evidence that postop VAS and proportion of new fractures does not significantly differ based upon fracture shape (wedge or biconcave), ie, equivocal rates of fracture and similar VAS scores based on shape. However, greater correction is noted in the KA in wedge fractures compared to biconcave type.
In a retrospective comparative study, Wu et al3 investigated the possible risk factors of secondary adjacent vertebral fractures after PKP in the treatment of OVCF. The authors concluded that “Fissure fracture, absence of systemic anti-osteoporosis therapy, leakage of bone cement into intervertebral disc, topical anesthesia and loss in bone density are high-risk factors of secondary adjacent vertebral fracture after PKP.” This paper provides Level III evidence that fracture type, use of anti-osteoporotic treatment, and bone density are factors associated with the development of secondary AVF after PKP in OVCF patients. References: 1. Chou KN, Lin BJ, Wu YC, Liu MY, Hueng DY. Progressive kyphosis after vertebroplasty in osteoporotic vertebral compression fracture. Spine (Phila Pa 1976). 2014;39(1):68-73. doi:10.1097/BRS.0000000000000042 2. De Kong L, Meng LC, Shen Y, Wang LF, Wang P, Shang ZK. Effect of shape and severity of vertebral fractures on the outcomes of kyphoplasty. Acta Orthop Belg. 2013;79(5):565-571. 3. Wu J, Guan Y, Fan S. Analysis of risk factors of secondary adjacent vertebral fracture after percutaneous kyphoplasty. Biomedical Research (India). 2017;28(5):1956-1961.
Work Group Narrative: The following Grade I recommendations (insufficient evidence) are separate as each convey a different focus and do not fit with other recommendations: There is insufficient evidence to make a recommendation for or against the presence of osteonecrosis being predisposing factors for recollapse in adults undergoing vertebroplasty for osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a retrospective comparative study, Heo et al1 examined the incidence rate and risk factors associated with recollapse of the same vertebrae in patients after having undergone PVP. The authors concluded that “The most important predisposing factor for recollapse was pre-operative osteonecrosis. Recollapse was not related to trauma. Osteoporotic vertebral compression fracture with osteonecrosis or pseudoarthrosis has been regarded as a relative indication for PVP; however, the findings of this study suggest that this disease category may be a relative contraindication for PVP.” This paper provides Level III evidence that the presence of osteonecrosis and the degree of free expansion of vertebral compression fracture are predisposing factors for recollapse in patients undergoing vertebroplasty for OVCF. References: 1. Heo DH, Chin DK, Yoon YS, Kuh SU. Recollapse of previous vertebral compression fracture after percutaneous vertebroplasty. Osteoporos Int. 2009;20:473–480.
There is insufficient evidence for or against the occurrence of intradiscal cement leakage in the presence of high signal T2 intensity in the adjacent disc in the absence of endplate cortical disruption.
Grade of Recommendation: I
In a retrospective comparative study, Hong et al1 analyzed clinical and preoperative MRI risk factors of intradiscal cement leakage. The authors concluded that “There was no adjacent intradiscal cement leakage without endplate cortical disruption. Abnormal T2 hyperintensity in adjacent discs may be related to intradiscal cement leakage, but only in the presence of endplate cortical disruption. Also, not having Kümmell’s disease did not prevent intradiscal cement leakage. Thus, given these circumstances, careful cement injection is needed to reduce intradiscal cement leakage.” This paper provides Level III evidence that intradiscal cement leakage occurs in the presence of high signal T2 intensity in the adjacent disc. References: 1. Hong SJ, Lee S, Yoon JS, Kim JH, Park YK. Analysis of intradiscal cement leakage during percutaneous vertebroplasty: multivariate study of risk factors emphasizing preoperative MR findings. J Neuroradiol. 2014;41(3):195-201. doi:10.1016/j.neurad.2013.07.004
There is insufficient evidence for or against IVC and posterior fascia edema being associated with residual backpain after vertebral augmentation in adults with osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a retrospective comparative study, Li et al1 described the incidence of and risk factors for residual back pain due to OVCF in patients following PKP treatment. The authors concluded that “The incidence of postoperative residual back pain was 7.8% among 809 OVCF patients following PKP. The presence of an intravertebral vacuum cleft, posterior fascia oedema, facet joint violations and a separated cement distribution were identified as independent risk factors for residual back pain.” The work group downgraded this potential Level III paper due to nonrandomization. This paper provides Level IV evidence that IVC and posterior fascia edema are fracture-specific risk factors associated with increased likelihood of residual back pain after PKP. References: 1. Li Y, Yue J, Huang M, et al. Risk factors for postoperative residual back pain after percutaneous kyphoplasty for osteoporotic vertebral compression fractures. Eur Spine J. 2020;29(10):2568-2575. doi:10.1007/s00586-020-06493-6
There is insufficient evidence for or against adjacent segment alignment and thoracolumbar alignment being associated with adjacent level fractures after vertebral augmentation in adults with osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a retrospective comparative study, Liang et al1 assessed the radiographic and MRI findings that could possibly predict the risk of adjacent segmental fractures when PVP is used to treat osteoporotic thoracolumbar fractures. The authors concluded that “the preoperative ASA and TLA on MRI were risk factors associated with ASFs in OTFs treated with PV.” The work group downgraded this potential Level III paper due to nonconsecutive patients and nonrandomization. This paper provides Level IV evidence that preoperative fracture specific radiographic metrics such as adjacent segment alignment (ASA) and thoracolumbar alignment (TLA) are factors associated with adjacent segment fractures after PV for osteoporotic thoracolumbar fractures (OTF). Instead, the authors used correlation analysis, which is sort of a crude/unadjusted analysis. References: 1. Liang X, Zhong W, Luo X, Quan Z. Risk factors of adjacent segmental fractures when percutaneous vertebroplasty is performed for the treatment of osteoporotic thoracolumbar fractures. Sci Rep. 2020;10(1):399. Published 2020 Jan 15. doi:10.1038/s41598-019-57355-1
FLASK Future Directions for Research
The work group recommends high-quality prospective studies with documentation of fracture-specific data to identify factors related with clinical and radiological outcomes after vertebral augmentation for osteoporotic vertebral compression fractures.