Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care
Diagnosis and Treatment of Adults with Osteoporotic Vertebral Fractures
Recommendations:
Natural History
Key Recommendations
- Acute vertebral fracture is defined by the presence of edema on MRI. [“Glossary and Acronyms”]
- Compared to medical treatment, vertebral augmentation is recommended as it provides rapid and sustained clinically and statistically significant improvement in pain and function in patients with acute osteoporotic vertebral compression fractures. [Interventional Treatment Question 3]
There is a paucity of literature reviewed that looked solely at untreated (or conservatively treated) patient cohorts. Therefore, when possible, the work group evaluated the control arm of comparative studies as a natural history cohort. Although some studies may report that there was no difference in a treatment between an intervention group and a “natural history” group, there could still be a decline in baseline within the “natural history” (and perhaps the treatment) group(s). There was no evidence available regarding the natural decline of healthy age-matched patients; however, most of these studies are looking at 6-week or 6- to 12-month follow-up, rather than several years when a more dramatic decline from aging might be expected. When reviewing these studies, the work group solely focused on the untreated group disregarding the authors’ comparisons as they were not relevant to the questions identified.
Natural History Question 1: For patients with osteoporotic vertebral compression fractures managed without augmentation or surgery, what is the risk of development of long-term sequelae of vertebral compression fractures (eg, spinal deformity, respiratory compromise, gastrointestinal tract dysfunction, or physical and/or psychological functional impairment)?
In adults with osteoporotic vertebral compression fractures treated without augmentation or surgery, there is fair evidence to suggest that decline occurs in functional status and activities of daily living.
Grade of Recommendation: B
In a prospective observational study, Matsumoto et al1 aimed to determine the prognostic factors that indicated reduced activities of daily living (ADL) 6-months following an osteoporotic vertebral compression fracture (OVCF). The work group downgraded this potential Level I paper due to less than 80% follow-up. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that 21% of adults with OVCF treated without augmentation or surgery experienced a reduction in ADLs at 6 months. In a retrospective case control study, Hoshino et al2 investigated the effectiveness of balloon kyphoplasty for patients with acute osteoporotic vertebral fractures and poor prognostic factors. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that the medical management approach may result in a decrease in ADLs and be less effective in preventing vertebral deformity. In a prospective observational study, Hoshino et al3 assessed whether initial medical management for patients with osteoporotic vertebral fractures impact patient outcomes. The work group downgraded this potential Level II paper due to less than 80% follow-up. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that, this paper provides Level III evidence that after 6 months of conservative therapy ~1/5 pts had reduced ADLs, 1/4 pts had prolonged back pain, ~1/3 had further vertebral body collapse and 1/20 pts had cognitive decline. In a prospective case control study, Klezl et al4 aimed to determine the functional and social implications of balloon kyphoplasty (BKP) in patients who had OVCF. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that of patients with OVCF managed without augmentation or surgery requiring admission to hospital, 21.6% died and 52.9% experienced decrease in function at one-year follow-up. References 1. Matsumoto T, Hoshino M, Tsujio T, et al. Prognostic factors for reduction of activities of daily living following osteoporotic vertebral fractures. Spine (Phila Pa 1976). 2012;37(13):1115-1121. doi:10.1097/BRS.0b013e3182432823 2. Hoshino M, Takahashi S, Yasuda H, et al. Balloon Kyphoplasty Versus Conservative Treatment for Acute Osteoporotic Vertebral Fractures With Poor Prognostic Factors: Propensity Score Matched Analysis Using Data From Two Prospective Multicenter Studies. Spine (Phila Pa 1976). 2019;44(2):110-117. doi:10.1097/BRS.0000000000002769. 3. Hoshino M, Tsujio T, Terai H, et al. Impact of initial conservative treatment interventions on the outcomes of patients with osteoporotic vertebral fractures. Spine (Phila Pa 1976). 2013;38(11):E641-E648. doi:10.1097/BRS.0b013e31828ced9d 4. Klezl Z, Bhangoo N, Phillips J, Swamy G, Calthorpe D, Bommireddy R. Social implications of balloon kyphoplasty: prospective study from a single UK centre. Eur Spine J. 2012;21(9):1880-1886. doi:10.1007/s00586-012-2262-7
In adults with osteoporotic vertebral compression fractures treated without augmentation or surgery, there is poor quality evidence that there may be progressive kyphosis and loss of vertebral body height.
Grade of Recommendation: C
eIn a retrospective case control study, Park et al1 analyzed the preventative effects of short-term teriparatide on the progression of vertebral body collapse after an OVCF. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that kyphosis and wedge angle increase, while anterior and middle column heights decrease in OVCF long-term. In a retrospective case control study, Colangelo et al2 examined recovery, quality of life, and deformity prevention effectiveness between kyphoplasty and medical management (bracing immobilization) in postmenopausal woman with osteoporotic vertebral compression fractures. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level IV evidence that kyphosis angles increased by 6.7% at 12 months for adults with OVCF treated without augmentation or surgery. References 1. Park JH, Kang KC, Shin DE, Koh YG, Son JS, Kim BH. Preventive effects of conservative treatment with short-term teriparatide on the progression of vertebral body collapse after osteoporotic vertebral compression fracture. Osteoporos Int. 2014;25(2):613-618. doi:10.1007/s00198-013-2458-7 2. 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.
In adults with osteoporotic vertebral compression fractures treated without augmentation or surgery, there is poor quality evidence that there may be significant medical morbidity associated with the fracture.
Grade of Recommendation: C
In a prospective comparative study, Du et al1 evaluated the decision of conservative versus surgical treatment of multisegment thoracolumbar (TL) OCVF based on the assessment system of thoracolumbar osteoporotic fracture (ASTLOF). The medical management group included bedrest, although the duration was unclear. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that 9.2% of adults with OVCF treated without augmentation or surgery developed a bed-related complication and loss of height of 11.4%. In a retrospective case series study, Edidin et al2 compared the mortality and morbidity for patients with vertebral compression fracture (VCF) undergoing BKP, medical management (nonoperative), and vertebroplasty (VP). After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level IV evidence that nonoperative treatment has 55% and 25% higher adjusted risk of mortality than BKP and VP. In a retrospective case series study, McCullough et al3 studied the medical outcomes following spinal augmentation or conservative therapy treatment of osteoporotic vertebral fractures. The work group downgraded this potential Level III paper given the nature of the uncertainties in the diagnostic accuracy of large administrative databases, compared to pure prospectively enrolled studies. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level IV evidence that, through the use of Medicare data, patients with OVCF treated without augmentation or surgery experience a mortality rate of 6.7% and an incidence of major medical complication of 28.9% at one year following OCVF.6 References 1. Du JP, Fan Y, Liu JJ, et al. The analysis of MSTMOVCF (Multi-segment thoracolumbar mild osteoporotic fractures surgery or conservative treatment) based on ASTLOF (the assessment system of thoracolumbar osteoporotic fracture). Sci Rep. 2018;8(1):8185. Published 2018 May 29. doi:10.1038/s41598-018-26562-7 2. Edidin AA, Ong KL, Lau E, Kurtz SM. Morbidity and Mortality After Vertebral Fractures: Comparison of Vertebral Augmentation and Nonoperative Management in the Medicare Population. Spine (Phila Pa 1976). 2015;40(15):1228-1241. doi:10.1097/BRS.0000000000000992 3. McCullough BJ, Comstock BA, Deyo RA, Kreuter W, Jarvik JG. Major medical outcomes with spinal augmentation vs conservative therapy. JAMA Intern Med. 2013;173(16):1514-1521. doi:10.1001/jamainternmed.2013.8725
In adults with osteoporotic vertebral compression fractures treated without augmentation or surgery, there is poor quality evidence that patients are at risk of additional fractures.
Grade of Recommendation: C
In a prospective randomized control trial study, Kato et al1 compared the preventative effects of the different brace treatments on clinical results, such as the deformity of the vertebral body, in patients with VCFs. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that adults with acute OVCF treated without augmentation or surgery have a 5.6% risk of developing new fractures by 48 weeks. In a retrospective case control study, Levy et al2 assessed the effectiveness of medical and surgical therapies on the prevention of recurrent fractures and mortality rates. The work group downgraded this potential Level III paper due to different times of enrollment. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level IV evidence that adults with OVCF treated without augmentation or surgery have a 6% refracture rate and a 24.8% mortality rate. In a retrospective comparative study, Lin et al3 aimed to determine the effects of an early VP intervention on aged patients with painful vertebral compression fractures by comparing the risks that come of mortality and respiratory-related morbidity. The work group downgraded this potential Level III paper due to the possible crossover of patients and an unclear intervention. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level IV evidence that in adults with OVCF treated without augmentation or surgery the risk of mortality was 389 over 61,427 person-months observed.
References 1. Kato T, Inose H, Ichimura S, et al. Comparison of Rigid and Soft-Brace Treatments for Acute Osteoporotic Vertebral Compression Fracture: A Prospective, Randomized, Multicenter Study. J Clin Med. 2019;8(2):198. Published 2019 Feb 6. doi:10.3390/jcm8020198 2. Levy H, Seydafkan S, Rice JD, Easley KA, Tangpricha V. Comparative efficacy of vertebroplasty, kyphoplasty, and medical therapy for vertebral fractures on survival and prevention of recurrent fractures. Endocr Pract. 2012;18(4):499–507. 3. Lin JH, Chien LN, Tsai WL, Chen LY, Chiang YH, Hsieh YC. Early vertebroplasty associated with a lower risk of mortality and respiratory failure in aged patients with painful vertebral compression fractures: a population-based cohort study in Taiwan. Spine J. 2017;17(9):1310–1318.
FLASK Future Directions for Research
The work group recommends high-quality studies to identify and optimize the most effective elements of nonoperative/medical management.
Natural History Question 2: For patients with acute osteoporotic vertebral compression fractures managed without augmentation or surgery, what is the expected time to resolution of pain?
In adults with osteoporotic vertebral compression fractures treated without augmentation or surgery, there is fair evidence to suggest that significant pain improvement will occur. Time course to improvement is variable from 3 months to 1 year. In some studies, the time may be overstated due to the interval of follow-up and the time to improvement may vary due to different medical therapies.
Grade of Recommendation: B
6In a prospective observational study, Andrei et al1 evaluated the effectiveness and safety of VP and the medical management of osteoporotic vertebral fractures. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that adults with OVCF treated without augmentation or surgery improve by 6 months and are off analgesics by 2 weeks. The mean VAS was improved from 6.28 (at onset) to 3.0 at 6 months and 2.36 at 12 months with medical management (starting at 6.28). In a prospective comparative study, Diamond et al2 analyzed whether percutaneous vertebroplasty (PVP) can be an effective treatment for osteoporotic vertebral fractures. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that the pain levels continue to improve to 12 months in adults with OVCF treated without augmentation or surgery. In a prospective observational study, Du et al3 studied the decision of conservative versus surgical treatment of multisegment TL OVCF based on ASTLOF. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that patients treated without augmentation or surgery experience improvement in pain to one year; however, the nature of the study makes it difficult to determine when the improvement plateaus. In a prospective randomized control trial study, Kato et al4 investigated the preventative effects of different brace treatments on clinical results, such as the deformity of the vertebral body, in patients with VCF. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that adults with OVCF treated without augmentation or surgery have significant improvement in pain by 12 weeks. In a prospective observational study, Klazen et al5 examined whether VP has better outcomes compared to medical management in patients with acute vertebral fractures. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that adults with OVCF treated without augmentation or surgery will gradually improve until 3 months and achieve significant improvement on average by 115 days. In a prospective observational study, Klazen et al6 aimed to determine the natural course of pain in patients with conservatively treated acute OCVF, while also assessing the different types of medical management. The work group downgraded this potential Level I paper due to follow-up not being standardized and less than 80% follow-up. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that adults with OVCF treated without augmentation or surgery (mostly without bracing) have improvement of significant back pain at 6 months. In a prospective observational study, Li et al7 compared the therapeutic effectiveness of percutaneous kyphoplasty to medical management in older adults with osteoporotic vertebral compression fractures. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that patients treated with bedrest will have significant improvement in pain by 1 month with continued improvement up to 6 months. In a prospective observational study, Piazzolla et al8 evaluated the evolution of vertebral bone marrow edema (VBME) on conservatively treated vertebral compression fractures, while also evaluating the relationship between VBME reduction, and clinical symptom improvement. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that VAS improved over 90 days but remained above a mean value of 3 in adults with OVCF treated without augmentation or surgery. In a prospective observational study, Venmans et al9 analyzed the conservatively treated patients from the VERTOS II trial, particularly those who developed chronic back pain. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that less than 50% of adults with OVCF treated without augmentation or surgery had a VAS less than 4 at 3 months and this improved to 60% with VAS less than 3 at one year. In a prospective observational study, Blasco et al10 compared the effects of VP and medical management on quality of life and pain relief in patients with osteoporotic vertebral fractures, while also analyzing the secondary adverse effects and development of new fractures in both treatment groups. The work group downgraded this potential Level II paper due to less than 80% follow-up and no values found for 6-month and 12-month data. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that adults with OVCF treated without augmentation or surgery have significant improvement in back pain by 1 year, but 42% still experience moderate or severe pain at 12 months. In a prospective observational study, Boonen et al11 compared the efficacy of kyphoplasty with conservative standard nonsurgical management in the treatment of patients with acute vertebral compression fractures over 2 years. The work group downgraded this potential Level II paper due to less than 80% follow-up and the study being industry funded. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that LBP improves steadily until 12 months after fracture, but a subgroup of treated patients have persistent back pain (VAS > 3.0) at 24 months. In a prospective observational study, Diamond et al12 examined the safety and effectiveness of percutaneous vertebroplasty for the treatment of patients with acute osteoporotic vertebral fractures. The work group downgraded this potential Level II paper due to small sample size, diagnostic methods not described, possible selection bias, and the patients not being enrolled at the same point in their disease. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that adults with OVCF treated without augmentation or surgery experienced an 80% reduction in pain scores at 6-12 months and an 85% reduction at 48 months after fracture. In a prospective observational study, Hoshino et al13 investigated the effectiveness of BKP for patients with acute osteoporotic vertebral fractures and poor prognostic factors. The work group downgraded this potential Level II paper due to less than 80% follow-up. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that pain from OVCF that was treated without augmentation or surgery significantly improves (Mean VAS 36.1 at 6 months). In a prospective observational study, Hoshino et al14 assessed whether initial medical management for patients with osteoporotic vertebral fractures impact patient outcomes. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that by 6 months, 74.3% of adults with OVCF treated without augmentation or surgery have significant improvement in back pain. In a retrospective case series study, Iwata et al15 aimed to determine independent risk factors for residual low back pain following an osteoporotic vertebral fracture. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that improvement plateaus around 3 weeks postfracture in adults with OVCF treated without augmentation or surgery. In a prospective comparative study, Kim et al16 studied the preoperative prognostic factors related to the impact of VP on acute pain using a cohort of patients who were either surgically or non-surgically managed. The work group downgraded this potential Level II paper due to the patients not being enrolled at the same point in their disease and 35% crossover rate. For example, patients who did not improve after 3 weeks were given a choice of the VP treatment. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that pain improvement plateaus between 4-6 weeks after fracture for both groups, and there is a significant difference in VAS at 12 weeks for the two groups. In a prospective comparative study, Ma et al17 examined the 3-month therapeutic effects of teriparatide (TPTD) and percutaneous vertebroplasty (PVP) on patients with acute osteoporotic vertebral compression fractures. The work group downgraded this potential Level II paper due to the data values not being available and nonrandomization. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that patients treated with teriparatide demonstrate a steady improvement in their pain out to 3 months. In a prospective comparative study, Meccariello et al18 compared the effectiveness of a dynamic corset brace and 3-point brace in the treatment of osteoporotic compression fractures. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that patients with acute OCVF treated with bracing have improvement in pain until 3 months after which, it plateaus out to a 6-month measurement, independent of the type of brace worn. In a prospective observational study, Movrin et al19 investigated the incidence and risk factors of adjacent level fractures by comparing BKP and medical management. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that the work group downgraded this potential Level II paper due to selection bias (only patients with a VAS > 5 were enrolled), and indirectness of evidence. This paper provides Level III evidence that pain improves over time with conservative care but does not resolve it. In a prospective observational study, Wardlaw et al20 (1-year follow-up) and Van Meirhaeghe et al21 (2-year follow-up) compared the effectiveness and safety of BKP with nonsurgical management (NSM) in the treatment of patients with painful vertebral compression fractures, during a 24-month duration. In total, 99% of the patients in both groups had osteoporotic etiology and 1% had myeloma. The work group downgraded this potential Level II paper due to less than 80% follow-up. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that pain improves over 24-month periods but the NSM group had a mean VAS of 3.65 (improved from 6.93). References: 1. Andrei D, Popa I, Brad S, et al. The variability of vertebral body volume and pain associated with osteoporotic vertebral fractures: conservative treatment versus percutaneous transpedicular vertebroplasty. Int Orthop. 2017;41(5):963-968. doi:10.1007/s00264-017-3409-2 2. 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 3. Du JP, Fan Y, Liu JJ, et al. The analysis of MSTMOVCF (Multi-segment thoracolumbar mild osteoporotic fractures surgery or conservative treatment) based on ASTLOF (the assessment system of thoracolumbar osteoporotic fracture). Sci Rep. 2018;8(1):8185. Published 2018 May 29. doi:10.1038/s41598-018-26562-7 4. Kato T, Inose H, Ichimura S, et al. Comparison of Rigid and Soft-Brace Treatments for Acute Osteoporotic Vertebral Compression Fracture: A Prospective, Randomized, Multicenter Study. J Clin Med. 2019;8(2):198. Published 2019 Feb 6. doi:10.3390/jcm8020198 5. Klazen CA, Lohle PN, de Vries J, et al. Vertebroplasty 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 6. Klazen CA, Verhaar HJ, Lohle PN, et al. Clinical course of pain in acute osteoporotic vertebral compression fractures. J Vasc Interv Radiol. 2010;21(9):1405-1409. doi:10.1016/j.jvir.2010.05.018 7. 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. 8. Piazzolla A, Solarino G, Lamartina C, et al. Vertebral Bone Marrow Edema (VBME) in Conservatively Treated Acute Vertebral Compression Fractures (VCFs): Evolution and Clinical Correlations. Spine (Phila Pa 1976). 2015;40(14):E842-E848. doi:10.1097/BRS.0000000000000973 9. Venmans A, Klazen CA, Lohle PN, Mali WP, van Rooij WJ. Natural history of pain in patients with conservatively treated osteoporotic vertebral compression fractures: results from VERTOS II. AJNR Am J Neuroradiol. 2012;33(3):519-521. doi:10.3174/ajnr.A2817 10. Blasco J, Garcia A, Manzanera LSR, et al. Randomized trial comparing vertebroplasty and conservative treatment analyzing pain relief and quality of life on the long term basis. Cardiovasc Intervent Radiol. 2010;33:182-183. 11. Boonen S, Van Meirhaeghe J, Bastian L, et al. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. J Bone Miner Res. 2011;26(7):1627-1637. doi:10.1002/jbmr.364 12. 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 13. Hoshino M, Takahashi S, Yasuda H, et al. Balloon Kyphoplasty Versus Conservative Treatment for Acute Osteoporotic Vertebral Fractures With Poor Prognostic Factors: Propensity Score Matched Analysis Using Data From Two Prospective Multicenter Studies. Spine (Phila Pa 1976). 2019;44(2):110-117. doi:10.1097/BRS.0000000000002769. 14. Hoshino M, Tsujio T, Terai H, et al. Impact of initial conservative treatment interventions on the outcomes of patients with osteoporotic vertebral fractures. Spine (Phila Pa 1976). 2013;38(11):E641-E648. doi:10.1097/BRS.0b013e31828ced9d 15. Iwata A, Kanayama M, Oha F, et al. Is Bone Nonunion, Vertebral Deformity, or Spinopelvic Malalignment the Best Therapeutic Target for Amelioration of Low Back Pain After Osteoporotic Vertebral Fracture?. Spine (Phila Pa 1976). 2020;45(13):E760-E767. doi:10.1097/BRS.0000000000003422 16. Kim YC, Bok DH, Chang HG, et al. Increased sagittal vertical axis is associated with less effective control of acute pain following vertebroplasty. Bone Joint Res. 2016;5(11):544-551. doi:10.1302/2046-3758.511.BJR-2016-0135.R1 17. 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 18. Meccariello L, Muzii VF, Falzarano G, et al. Dynamic corset versus three-point brace in the treatment of osteoporotic compression fractures of the thoracic and lumbar spine: a prospective, comparative study. Aging Clin Exp Res. 2017;29(3):443-449. doi:10.1007/s40520-016-0602-x 19. 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 20. 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 21. 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
FLASK Future Directions for Research
The work group recommends high-quality studies to identify and optimize the most effective elements of nonoperative/medical management. The work group also recommends studies to identify the correlation of the patient’s perspective in measuring pain improvement (absolute value, degree of change, rate of change, timing, etc.) and health-related quality of life (HRQOL).
Natural History Question 3: For patients with acute osteoporotic vertebral compression fractures managed without augmentation or surgery, what is the risk of persistent long-term (>6 months) pain?
In adults with osteoporotic vertebral compression fractures treated without augmentation or surgery, there is fair evidence to suggest that a significant percentage of patients will have persistent long-term (greater than 6 months) pain (VAS >3). Most studies suggest approximately a third of patients (ranging from 10-40%).
Grade of Recommendation: B In a prospective observational study, Du et al1 analyzed the usefulness of the multisegment thoracolumbar mild osteoporotic fractures surgery or medical management (MSTMOVCF) system to direct care. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that treatment without augmentation or surgery allows significant improvement in both VAS and ODI.
In a prospective observational study, Hoshino et al2 assessed whether initial medical management for patients with osteoporotic vertebral fractures impact patient outcomes. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that 26% of adults with OVCF treated without augmentation or surgery will have persistent back pain at 6 months.
In a prospective observational study, Klazen et al3 aimed to determine whether VP has better outcomes compared to medical management in patients with acute vertebral fractures. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that a select group of patients with OVCF who underwent vertebroplasty improved more quickly and to a greater magnitude than OVCF patients who did not have this procedure. Some patients in either group continued to have persistent pain, although the VP group had less pain overall.
In a prospective observational study, Klazen et al4 studied the natural course of pain in patients with conservatively treated acute OVCF, while also assessing the different types of medical management. The work group downgraded this potential Level I paper due to follow-up not being standardized and less than 80% follow-up. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that approximately 1/3 of adults with OVCF treated without augmentation or surgery have persistent pain after 6 months and up to 23 months.
In a prospective comparative study, Meccariello et al5 compared the effectiveness of a dynamic corset brace and 3-point brace in the treatment of osteoporotic compression fractures. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that treating OVCF with a dynamic orthosis had a slightly higher VAS improvement compared to a more rigid brace at 3 and 6 months, although both brace groups continued to have some pain.
In a prospective observational study, Venmans et al6 evaluated the conservatively treated patients from the VERTOS II trial, particularly those who developed chronic back pain. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that 40% of adults with OVCF treated without augmentation or surgery still have significant pain (VAS >4) at 1 year.
In a prospective observational study, Boonen et al7 compared the efficacy of kyphoplasty with conservative standard NSM in the treatment of patients with acute vertebral compression fractures over 2 years. The work group downgraded this potential Level II paper due to less than 80% follow-up and the study being industry funded. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that 10% of adults with OVCF treated without augmentation or surgery will still take opioids for pain at 2 years.
In a retrospective observational study, Iwata et al8 aimed to determine independent risk factors for residual low back pain following an osteoporotic vertebral fracture. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that approximately 26% of adults with OVCF treated without augmentation or surgery have persistent pain and 24% of patients had ODI LBP scores > 40% at 6 months.
In a prospective observational study, Yasuda et al9 assessed how delayed union following OVCF influences the condition of patients. The work group downgraded this potential Level II paper due to less than 80% follow-up. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that approximately 10-15% of patients in both groups remained in severe pain at 6 months. References 1. Du JP, Fan Y, Liu JJ, et al. The analysis of MSTMOVCF (Multi-segment thoracolumbar mild osteoporotic fractures surgery or conservative treatment) based on ASTLOF (the assessment system of thoracolumbar osteoporotic fracture). Sci Rep. 2018;8(1):8185. Published 2018 May 29. doi:10.1038/s41598-018-26562-7 2. Hoshino M, Tsujio T, Terai H, et al. Impact of initial conservative treatment interventions on the outcomes of patients with osteoporotic vertebral fractures. Spine (Phila Pa 1976). 2013;38(11):E641-E648. doi:10.1097/BRS.0b013e31828ced9d 3. Klazen CA, Lohle PN, de Vries J, et al. Vertebroplasty 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 4. Klazen CA, Verhaar HJ, Lohle PN, et al. Clinical course of pain in acute osteoporotic vertebral compression fractures. J Vasc Interv Radiol. 2010;21(9):1405-1409. doi:10.1016/j.jvir.2010.05.018 5. Meccariello L, Muzii VF, Falzarano G, et al. Dynamic corset versus three-point brace in the treatment of osteoporotic compression fractures of the thoracic and lumbar spine: a prospective, comparative study. Aging Clin Exp Res. 2017;29(3):443-449. doi:10.1007/s40520-016-0602-x 6. Venmans A, Klazen CA, Lohle PN, Mali WP, van Rooij WJ. Natural history of pain in patients with conservatively treated osteoporotic vertebral compression fractures: results from VERTOS II. AJNR Am J Neuroradiol. 2012;33(3):519-521. doi:10.3174/ajnr.A2817 7. Boonen S, Van Meirhaeghe J, Bastian L, et al. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. J Bone Miner Res. 2011;26(7):1627-1637. doi:10.1002/jbmr.364 8. Iwata A, Kanayama M, Oha F, et al. Is Bone Nonunion, Vertebral Deformity, or Spinopelvic Malalignment the Best Therapeutic Target for Amelioration of Low Back Pain After Osteoporotic Vertebral Fracture?. Spine (Phila Pa 1976). 2020;45(13):E760-E767. doi:10.1097/BRS.0000000000003422 9. Yasuda H, Hoshino M, Tsujio T, et al. Difference of clinical course between cases with bone union and those with delayed union following osteoporotic vertebral fractures. Arch Osteoporos. 2017;13(1):3. doi:10.1007/s11657-017-0411-7
FLASK Future Directions for Research
The work group recommends high-quality studies to identify risk factors that predispose patients to persistent pain.
Natural History Question 4: For patients with osteoporotic vertebral compression fractures, are rates of morbidity and mortality different for those managed with augmentation or surgery versus those managed without?
There is fair evidence to suggest that the new fracture rates are not different in adults with osteoporotic vertebral compression fractures treated with augmentation or surgery as compared to medical treatment.
Grade of Recommendation: B
In a prospective observational study, Du et al1 evaluated the usefulness of the MSTMOVCF system to direct care. After evaluating the results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that the group treated without augmentation or surgery had similar risk of developing new fractures as the operative cohort.
In a prospective observational study, Boonen et al2 compared the efficacy of kyphoplasty with conservative standard NSM in the treatment of patients with acute VCF over 2 years. The work group downgraded this potential Level II paper due to less than 80% follow-up and the study being industry funded. After evaluating the results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that the risk of developing new fractures is comparable between groups at 24 months (47.5% KP vs 44.1% treated without augmentation or surgery).
In a prospective comparative study, Kim et al3 aimed to determine the preoperative prognostic factors related to the impact of VP on acute pain using a cohort of patients who were either surgically or nonsurgically managed. The work group downgraded this potential Level II paper due to the patients not being enrolled at the same point in their disease and selection bias. For example, patients who did not improve after 3 weeks were given a choice of the VP treatment. After evaluating the results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that the risk of developing adjacent level fractures is comparable across groups (5.8% treated without augmentation or surgery vs 10.8% treated operatively). References 1. Du JP, Fan Y, Liu JJ, et al. The analysis of MSTMOVCF (Multi-segment thoracolumbar mild osteoporotic fractures surgery or conservative treatment) based on ASTLOF (the assessment system of thoracolumbar osteoporotic fracture). Sci Rep. 2018;8(1):8185. Published 2018 May 29. doi:10.1038/s41598-018-26562-7 2. Boonen S, Van Meirhaeghe J, Bastian L, et al. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. J Bone Miner Res. 2011;26(7):1627-1637. doi:10.1002/jbmr.364 3. Kim YC, Bok DH, Chang HG, et al. Increased sagittal vertical axis is associated with less effective control of acute pain following vertebroplasty. Bone Joint Res. 2016;5(11):544-551. doi:10.1302/2046-3758.511.BJR-2016-0135.R1
There is conflicting evidence that precludes making a recommendation on rates of morbidity and mortality for adults with osteoporotic vertebral compression fractures managed with augmentation or surgery compared to those managed without.
Grade of Recommendation: I
In a retrospective comparative study, Becker et al1 assessed the hospital treatment costs after BKP versus conservative treatment in patients with an OVCF. The work group noted that this study received industry funding. The work group downgraded this potential Level II paper due to follow-up not being standardized and diagnostic methods not being described. After evaluating the results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that there is no difference in mortality between BKP or treatment without augmentation or surgery. In a prospective observational study, Blasco et al2 investigated the effects of VP or medical management on quality of life and pain relief in patients with osteoporotic vertebral fractures, while also analyzing the secondary adverse effects and development of new fractures in both treatment groups. The work group downgraded this potential Level II paper due to less than 80% follow-up and no values found for 6- and 12-month data. After evaluating the results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that there are more clinical new fractures in the VP group than the group treated without augmentation or surgery, however there is no difference in mortality. In a prospective observational study, Boonen et al3 compared the efficacy of kyphoplasty with conservative standard NSM in the treatment of patients with acute VCFs over 2 years. The work group downgraded this potential Level II paper due to less than 80% follow-up. After evaluating the results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that patients receiving kyphoplasty compared to treatment without augmentation or surgery have small, but statistically significant improvement in EQ5D scores, back pain, SF-36 bodily pain, and patient satisfaction at 2 years postintervention without an increase in mortality, adjacent vertebral fractures or other adverse events. The number of outcome measures showing statistically significant differences decreases with time. In a retrospective comparative study, Chen et al4 analyzed the impact of nonoperative treatment, VP, and kyphoplasty on factors like survival rate, complications, length of hospital stay, hospital charges, discharge locations, readmissions, and repeat procedures in Medicare patients with VCFs. After evaluating the results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that there is a lower 3-year survival rate in the group treated without augmentation or surgery compared to VP or kyphoplasty although this may be due to selection bias. In a prospective observational study, Diamond et al5 examined the safety and effectiveness of percutaneous VP for the treatment of patients with acute osteoporotic vertebral fractures. After evaluating the results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that the mortality rate is the same for OVCF treated with VP compared to treated without augmentation or surgery, although pain and physical function were somewhat improved up to 6 weeks with VP. In a retrospective case control study, Gerling et al6 studied the survivorship rate after cement augmentation of refractory OVCFs with traditional pain management. After evaluating the results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that augmentation had significant improvement in survival compared to controls treated without augmentation or surgery. In a prospective comparative study, Kim et al7 aimed to determine the preoperative prognostic factors related to the impact of VP on acute pain using a cohort of patients who were either surgically or nonsurgically managed. The work group downgraded this potential Level II paper due to the patients not being enrolled at the same point in their disease and odd methodology. For example, patients who did not improve after 3 weeks were given a choice of the VP treatment. After evaluating the results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that for patients undergoing VP for OVCF there was 24% cement leakage, there was no difference in medical complications between groups (5.4% nonoperative vs 5% VP), no statistically significant difference in adjacent fractures (5.8% nonoperative vs 10.8% VP), improved VAS scores out to 6 weeks in the VP group although with SVA > 5cm, there did not appear to be a benefit of VP. In a retrospective case control study, Klezl et al8 investigated the functional and social implications of BKP in patients who have had OVCFs. The work group acknowledges a potential for selection bias. After evaluating the results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that patients who had BKP for OVCF had a lower mortality rate at 3 months compared to a historical control group treated without augmentation or surgery. In a retrospective case control study, Lange et al9 evaluated the survival and treatment costs for patients with osteoporotic VCFs who were treated by vertebral augmentation (VA) or medical management in Germany. After evaluating the results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that patients undergoing vertebral augmentation had a slightly lower death rate compared to a matched control group over 5 years. In a retrospective case control study, Lavelle et al10 assessed the effect of kyphoplasty on survival after a VCF. After evaluating the results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that the treatment of kyphoplasty did not seem to affect the survival rate of patients with osteoporotic VCFs. In a retrospective case control study, Ong et al11 examined the utilization of BKP and VP in the US older adult population. The work group noted that this study received industry funding. After evaluating the results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that augmentation was associated with a lower mortality at 10 years. In a retrospective case series study, McCullough et al12 compared the medical outcomes following spinal augmentation or conservative therapy treatment of osteoporotic vertebral fractures. The work group downgraded this potential Level III paper given the nature of the uncertainties in the diagnostic accuracy of large administrative databases, compared to pure prospectively enrolled studies. After evaluating the results for the purpose of answering this natural history question, the work group determined that this paper provides Level IV evidence that through the use of Medicare data, patients with OVCF treated without augmentation or surgery experience a mortality rate of 6.7% and an incidence of major medical complication of 28.9% at one year following OCVF. In a retrospective comparative study, Lin et al13 aimed to determine the effects of an early VP intervention on aged patients with painful VCFs by comparing the risks that come of mortality and respiratory-related morbidity. The work group downgraded this potential Level III paper due to the possible crossover of patients and an unclear intervention. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level IV evidence that in adults with OVCF treated without augmentation or surgery the risk of mortality was 389 over 61,427 person-months observed. In a retrospective case series study, Edidin et al14 compared the mortality and morbidity for VCF patients undergoing BKP, medical management (nonoperative), and VP. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level IV evidence that nonoperative treatment has 55% and 25% higher adjusted risk of mortality than BKP and VP (only comparative data was available). In a retrospective case control study, Levy et al15 assessed the effectiveness of medical and surgical therapies on the prevention of recurrent fractures and mortality rates. The work group downgraded this potential Level III paper due to different times of enrollment. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level IV evidence that adults with OVCF treated without augmentation or surgery have a 6% refracture rate and a 24.8% mortality rate. Zampini et al16 studied a database of patients 65 years of age or older with VCFs to evaluate complications and mortality. The work group downgraded this potential Level III study due to differences between cohorts of age, gender, and location. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level IV evidence that nonoperative treatment of OCVF was associated with a 1.6% rate of mortality, 1% overall complication risk, and 3.4% risk of pneumonia. 6 References 1. Becker S, Pfeiffer KP, Ogon M. Comparison of inpatient treatment costs after balloon kyphoplasty and non-surgical treatment of vertebral body compression fractures. Eur Spine J. 2011;20(8):1259-1264. doi:10.1007/s00586-011-1692-y 2. Blasco J, Garcia A, Manzanera LSR, et al. Randomized trial comparing vertebroplasty and conservative treatment analyzing pain relief and quality of life on the long term basis. Cardiovasc Intervent Radiol. 2010;33:182-183. 3. Boonen S, Van Meirhaeghe J, Bastian L, et al. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. J Bone Miner Res. 2011;26(7):1627-1637. doi:10.1002/jbmr.364 4. Chen AT, Cohen DB, Skolasky RL. Impact of nonoperative treatment, vertebroplasty, and kyphoplasty on survival and morbidity after vertebral compression fracture in the medicare population. J Bone Joint Surg Am. 2013;95(19):1729–1736. 5. 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 6. Gerling MC, Eubanks JD, Patel R, Whang PG, Bohlman HH, Ahn NU. Cement augmentation of refractory osteoporotic vertebral compression fractures: survivorship analysis. Spine (Phila Pa 1976). 2011;36(19):E1266-E1269. doi:10.1097/BRS.0b013e31820a0b3f 7. Kim YC, Bok DH, Chang HG, et al. Increased sagittal vertical axis is associated with less effective control of acute pain following vertebroplasty. Bone Joint Res. 2016;5(11):544-551. doi:10.1302/2046-3758.511.BJR-2016-0135.R1 8. Klezl Z, Bhangoo N, Phillips J, Swamy G, Calthorpe D, Bommireddy R. Social implications of balloon kyphoplasty: prospective study from a single UK centre. Eur Spine J. 2012;21(9):1880-1886. doi:10.1007/s00586-012-2262-7 9. Lange A, Kasperk C, Alvares L, Sauermann S, Braun S. Survival and cost comparison of kyphoplasty and percutaneous vertebroplasty using German claims data. Spine (Phila Pa 1976). 2014;39(4):318-326. doi:10.1097/BRS.0000000000000135 10. Lavelle WF, Khaleel MA, Cheney R, Demers E, Carl AL. Effect of kyphoplasty on survival after vertebral compression fractures. Spine J. 2008;8(5):763-769. doi:10.1016/j.spinee.2007.05.013 11. Ong KL, Beall DP, Frohbergh M, Lau E, Hirsch JA. Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty “sham” trials?. Osteoporos Int. 2018;29(2):375-383. doi:10.1007/s00198-017-4281-z 12. McCullough BJ, Comstock BA, Deyo RA, Kreuter W, Jarvik JG. Major medical outcomes with spinal augmentation vs conservative therapy. JAMA Intern Med. 2013;173(16):1514-1521. doi:10.1001/jamainternmed.2013.8725 13. Lin JH, Chien LN, Tsai WL, Chen LY, Chiang YH, Hsieh YC. Early vertebroplasty associated with a lower risk of mortality and respiratory failure in aged patients with painful vertebral compression fractures: a population-based cohort study in Taiwan. Spine J. 2017;17(9):1310–1318 14. Edidin AA, Ong KL, Lau E, Kurtz SM. Morbidity and mortality after vertebral fractures: Comparison of vertebral augmentation and nonoperative management in the medicare population. Spine. 2015;40(15):1228–1241. 15. Levy H, Seydafkan S, Rice JD, Easley KA, Tangpricha V. Comparative efficacy of vertebroplasty, kyphoplasty, and medical therapy for vertebral fractures on survival and prevention of recurrent fractures. Endocr Pract. 2012;18(4):499–507. 16. Zampini JM, White AP, McGuire KJ. Comparison of 5766 vertebral compression fractures treated with or without kyphoplasty. Clin Orthop Relat Res. 2010;468(7):1773–1780.
There is conflicting evidence that precludes making a recommendation for or against the impact of augmentation or surgery versus medical treatment on rate of medical complications in adults with osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a prospective observational study, Du et al1 analyzed the usefulness of the MSTMOVCF system to direct care. After evaluating the results for the purpose of answering this natural history question, the work group determined that this paper provides Level II evidence that the nonoperative group had 9.2% complications (pneumonia, UTI, bedsores, PE) vs 10.9% cement leak in the operative group. Both groups had similar adjacent fracture rates. This paper provides Level II evidence that morbidity was comparable between treatment without augmentation or surgery and interventional groups.
In a retrospective comparative study, Chen et al2 compared the impact of nonoperative treatment, VP, and kyphoplasty on factors like survival rate, complications, length of hospital stay, hospital charges, discharge locations, readmissions, and repeat procedures in Medicare patients with vertebral compression fractures. After evaluating the results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that medical complications generally appear to occur less in patients with OVCF treated with kyphoplasty compared to VP or treatment without augmentation or surgery, although selection bias may have a factor in these differences.
In a prospective comparative study, Kim et al3 studied the preoperative prognostic factors related to the impact of VP on acute pain using a cohort of patients who were either surgically or nonsurgically managed. The work group downgraded this potential Level II paper due to the patients not being enrolled at the same point in their disease and selection bias. For example, patients who did not improve after 3 weeks were given a choice of the VP treatment. After evaluating the results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that the interventional group had a 24.2% risk of cement leakage. No difference in medical complications occurred between groups (5.4% non-operative vs 5% intervention. References 1. Du JP, Fan Y, Liu JJ, et al. The analysis of MSTMOVCF (Multi-segment thoracolumbar mild osteoporotic fractures surgery or conservative treatment) based on ASTLOF (the assessment system of thoracolumbar osteoporotic fracture). Sci Rep. 2018;8(1):8185. Published 2018 May 29. doi:10.1038/s41598-018-26562-7 2. Chen AT, Cohen DB, Skolasky RL. Impact of nonoperative treatment, vertebroplasty, and kyphoplasty on survival and morbidity after vertebral compression fracture in the medicare population. J Bone Joint Surg Am. 2013;95(19):1729–1736. 3. Kim YC, Bok DH, Chang HG, et al. Increased sagittal vertical axis is associated with less effective control of acute pain following vertebroplasty. Bone Joint Res. 2016;5(11):544-551. doi:10.1302/2046-3758.511.BJR-2016-0135.R1
FLASK Future Directions for Research
The work group recommends high-quality studies to investigate the impact of augmentation or surgery as compared to medical treatment on mortality and medical complications in patients with osteoporotic vertebral compression fractures.
Natural History Question 5: For patients with osteoporotic vertebral compression fractures managed without augmentation or surgery, are there specific variables that increase the risk for refracture of the same or other vertebral levels?
There is insufficient evidence to make a recommendation for or against the impact of diabetes, smoking, NSAIDS, low FIM score, presentation of multiple fractures, or low segmental cobb angle on risk for refracture of the same or other vertebral level in adults with osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a prospective observational study, Diamond et al1 analyzed the safety and effectiveness of PVP for the treatment of patients with acute osteoporotic vertebral fractures. The work group downgraded this potential Level II paper due to small sample size, diagnostic methods not described, possible selection bias, and the patients not being enrolled at the same point in their disease. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that new fractures were found in 24% of patients for both VP and nonoperative groups with no specific risk factors identified. In a retrospective case control study, Faloon et al2 compared the rates of adjacent and remote-level VCFs in osteoporotic patients who were treated with either kyphoplasty or conservative care. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that the refracture rate was approximately 50%; diabetes mellitus (DM), smoking, and NSAIDS all increased secondary fracture risk; and there were no risk factors in the multivariate analysis in adults treated without augmentation or surgery. In a retrospective case control study, Yamauchi et al3 aimed to determine the factors associated with subsequent VCFs after conservative therapy treatment in patients with new fragility vertebral compression fractures, while also evaluating the parameters related with functional recovery in the acute period. The work group downgraded this potential Level II paper due to less than 80% follow-up. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that low lumbar BMD, low FIM score, and low segmental Cobb angle demonstrated an increased risk of subsequent fractures in adults treated without augmentation or surgery. Lindsay et al4 retrospectively analyzed the pooled data from 4 multicenter prospective studies to determine the incidence of a future vertebral fracture within one year of an existing vertebral fracture. After evaluating the control group results for the purpose of answering this natural history question, the work group determined that this paper provides Level III evidence that there is a 19.2% risk of developing new fractures after OVCF. References 1. 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 2. 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 3. Yamauchi K, Adachi A, Kameyama M, et al. A risk factor associated with subsequent new vertebral compression fracture after conservative therapy for patients with vertebral compression fracture: a retrospective observational study. Arch Osteoporos. 2020;15(1):9. Published 2020 Jan 3. doi:10.1007/s11657-019-0679-x 4. Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following a fracture. JAMA. 2001;285(3):320-323. doi:10.1001/jama.285.3.320
FLASK Future Directions for Research
The work group recommends high-quality studies to evaluate the risk factors for re-fracture rate in patients with osteoporotic vertebral compression fractures.