Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care
Diagnosis and Treatment of Adults with Osteoporotic Vertebral Fractures
Recommendations:
Surgical Treatment
Surgical Question 1: Does instrumented fusion improve outcomes in patients with acute osteoporotic vertebral compression fractures compared to nonoperative care or interventional procedures?
In adults with osteoporotic vertebral compression fractures with burst morphology, both vertebral augmentation and instrumented fusion may be considered as treatment options as they appear to provide similar clinical outcomes.
Grade of Recommendation: C
In a retrospective comparative study, An et al1 compared the clinical and radiological outcomes in patients undergoing PKP as a treatment for osteoporotic burst fractures refractory to conservative treatment of a 4-week duration. The authors concluded that “PKP is safe and useful for treating osteoporotic burst fractures.” The work group downgraded this potential Level III paper due to nonrandomized, nonmasked, and nonconsecutive patients, small sample size, selection bias, and the method of the assignment of patients to treatment groups not being described. This paper provides Level IV evidence that in female patients with OVCF with burst morphology, kyphoplasty, and instrumented fusion are equally effective in improving kyphosis, VAS, and mobility and both management approaches provide more improvement than medical treatment. In a retrospective comparative study, Kim et al2 compared the radiologic and clinical outcomes of patients with OVCF and intravertebral pseudarthrosis who underwent short segment percutaneous pedicle screw fixation (PPF) with PMMA augmentation to patients who were treated by percutaneous vertebroplasty. The authors concluded that “short-segment PPF with PMMA augmentation may be an effective minimally invasive treatment for cases of osteoporotic vertebral compression fractures with Kummell’s osteonecrosis.” The work group downgraded this potential Level III paper due to nonconsecutive patients, small sample size, and the method of treatment allocation not being described. This paper provides Level IV evidence that in patients with OVCF and nonhealing intravertebral cleft, PPF with PMMA versus PVP provides similar clinical outcomes but PPF with PMMA provides better radiological outcomes at 2-year post-treatment compared to PVP. References 1. An KC, Kang S, Choi JS, Seo JH. The clinical and radiological availability of percutaneous balloon kyphoplasty as a treatment for osteoporotic burst fractures. Asian Spine J. 2008;2(1):9-14. doi:10.4184/asj.2008.2.1.9 2. Kim HS, Heo DH. Percutaneous Pedicle Screw Fixation with Polymethylmethacrylate Augmentation for the Treatment of Thoracolumbar Intravertebral Pseudoarthrosis Associated with Kummell’s Osteonecrosis. BioMed Research International. 2016;2016:3878063.
There is conflicting evidence to make a recommendation for or against instrumented fusion in adults with acute osteoporotic vertebral compression fractures compared to interventional procedures with respect to radiological outcomes.
Grade of Recommendation: I
In a retrospective comparative study, An et al1 investigated the clinical and radiological outcomes in patients undergoing PKP as a treatment for osteoporotic burst fractures refractory compared to conservative treatment of a 4-week duration. The authors concluded that “PKP is safe and useful for treating osteoporotic burst fractures.” The work group downgraded this potential Level III paper due to nonrandomized, nonmasked, and nonconsecutive patients, small sample size, selection bias, and the method of the assignment of patients to treatment groups not being described. This paper provides Level IV evidence that in female patients with OVCF with burst morphology, kyphoplasty, and instrumented fusion are equally effective in improving kyphosis, VAS, and mobility and both management approaches provide more improvement than medical treatment. In a retrospective comparative study, Kim et al2 compared the radiologic and clinical outcomes of patients with OVCF and intravertebral pseudarthrosis who underwent short segment percutaneous PPF with PMMA augmentation to patients who were treated by percutaneous vertebroplasty. The authors concluded that “short-segment PPF with PMMA augmentation may be an effective minimally invasive treatment for cases of osteoporotic vertebral compression fractures with Kummell’s osteonecrosis.” The work group downgraded this potential Level III paper due to nonconsecutive patients, small sample size, and the method of treatment allocation not being described. This paper provides Level IV evidence that in patients with OVCF and nonhealing intravertebral cleft, PPF with PMMA versus PVP provides similar clinical outcomes but PPF with PMMA provides better radiological outcomes at 2 years post-treatment compared to PVP. References 1. An KC, Kang S, Choi JS, Seo JH. The clinical and radiological availability of percutaneous balloon kyphoplasty as a treatment for osteoporotic burst fractures. Asian Spine J. 2008;2(1):9-14. doi:10.4184/asj.2008.2.1.9 2. Kim HS, Heo DH. Percutaneous Pedicle Screw Fixation with Polymethylmethacrylate Augmentation for the Treatment of Thoracolumbar Intravertebral Pseudoarthrosis Associated with Kummell’s Osteonecrosis. BioMed Research International. 2016;2016:3878063. Doi: 10.1155/2016/3878063
FLASK Future Directions for Research
The work group recommends high-quality prospective studies identifying subgroups of patients with osteoporotic vertebral compression fractures that would benefit from surgical intervention more than interventional or nonoperative treatments.
Surgical Treatment Question 2: What are the clinical or radiological indications for recommending open surgical procedures in patients with acute osteoporotic vertebral compression fractures?
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 prospective studies identifying clinical or radiological characteristics in patients with osteoporotic vertebral compression fractures that would predict superior outcomes from open surgical treatment compared to medical or interventional treatments.
Surgical Question 3: Does the use of minimally invasive surgical approaches (eg, percutaneous pedicle screws, muscle-sparing decompression/arthrodesis techniques) improve outcomes compared to open surgical approaches in patients undergoing surgery for acute osteoporotic vertebral
There is insufficient evidence to make a recommendation for or against minimally invasive surgical approaches compared to open surgical approaches in adults undergoing surgery for acute osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a retrospective comparative study, Liu et al1 evaluated the efficacy of minimally invasive PPF compared to open pedicle screw fixation for osteoporotic vertebral fractures. The authors concluded that “both minimally invasive percutaneous pedicle screw and open pedicle screw fixation can achieve satisfactory internal fixation, while the former has less trauma, shorter operative time, fast recovery, few postoperative complications and lighter [sic] postoperative pain.” The work group downgraded this potential Level III paper due to nonconsecutive enrollment of patients, uncertainty of acute fracture, and inability to determine clinical significance. This paper provides Level IV evidence that in patients with OVCF undergoing surgical fixation, the use of minimally invasive percutaneous pedicle screws (compared to open pedicle screw placement) provides a greater magnitude of VAS improvement and ODI scores at 6 months and reduces operative time, intraoperative blood loss, hospital length of stay, and incision size. References 1. Liu G, Liu B, Yang Y, Tian L, Liu Y, Wang J. Minimally invasive percutaneous pedicle screw fixation versus open pedicle screw fixation for senile osteoporotic vertebral fracture. Int J Clin Exp Med. 2020;13(3):1816-1822.
FLASK Future Directions for Research
The work group recommends high quality comparative effectiveness trials examining minimally invasive vs open surgical procedures in patients undergoing surgery for osteoporotic vertebral compression fractures.
Surgical Treatment Question 4: What are the risk factors for adjacent vertebral body fractures after surgical intervention in patients with osteoporotic vertebral compression fractures?
There is insufficient evidence to identify risk factors for adjacent vertebral body fractures after surgical intervention in adults with osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a retrospective observational study, Tamai et al1 aimed to identify the independent risk factors and incidence of proximal junctional fractures (PJFr) in patients, following surgical treatment for osteoporotic vertebral collapse. The authors concluded that “PJFr was found in 16% [of] cases within 4 years after surgery; independent risk factors were severe osteoporosis and extended fusion to the sacrum. The lumbar BMD with cut-off value 0.61 g/cm2 may potentially predict PJFr. Our findings can help surgeons select perioperative adjuvant therapy, as well as a surgical strategy to prevent PJFr following surgery.” The work group downgraded this potential Level III paper due to inconsistent indications and applications of surgical and medical treatments across centers. This paper provides Level IV evidence that in patients undergoing instrumented fusion for osteoporotic fracture with a neurologic deficit, the following characteristics are associated with PJFr: severe baseline osteoporosis (based on a qualitative radiographic assessment) and when the lowest instrumented vertebrae (LIV) of the fusion construct is the sacrum. In addition, lumbar BMD rather than hip BMD is predictive of PJFr. References 1. Tamai K, Terai H, Suzuki A, et al. Risk Factors for Proximal Junctional Fracture Following Fusion Surgery for Osteoporotic Vertebral Collapse with Delayed Neurological Deficits: A Retrospective Cohort Study of 403 Patients. Spine Surgery & Related Research.3(2):171-177.
FLASK Future Directions for Research
The work group recommends prognostic studies evaluating risk factors for adjacent vertebral body fractures after surgical intervention in patients with osteoporotic vertebral compression fractures, possibly through a prospective multicenter registry.
Surgical Question 5: Are there specific characteristics of the fracture or the patient that influence outcomes in patients with osteoporotic vertebral compression fractures undergoing surgical treatment?
Spine care providers may consider preoperative hypoalbuminemia* as associated with an increased risk of post-operative mortality in adults undergoing surgical treatment for osteoporotic vertebral compression fractures. Grade of Recommendation: C *Work Group Narrative: The work group emphasizes that hypoalbuminemia, as it relates to the recommendation above, can be interpreted as a sign of physiologic stress, potentially resulting from disease or trauma‐related inflammation, rather than solely a reflection of nutrition status. The work group cautions providers to assess the underlying cause of hypoalbuminemia while applying this recommendation.
In a retrospective comparative study, Gupta et al1 aimed to determine the association between lower albumin levels and higher incidence of mortality, complications, 30-day readmission (postsurgical treatment for an OVCF). The authors concluded that “Preoperative albumin has the potential to serve as a prognostic indicator of adverse outcomes for patients undergoing surgery for OVCF.” This paper provides Level III evidence that preoperative hypoalbuminemia is associated with increased rates of postoperative complications in the surgical treatment of OVCF. In a retrospective case control study, Obha et al2 evaluated the preoperative factors that affected the postoperative mortality of patients who had undergone spinal surgery for an insufficient bone union following an osteoporotic vertebral fracture. The authors concluded that “preoperative hypoalbuminemia was associated with postoperative mortality following surgery for OVF.” The work group downgraded this potential Level III paper due to unclear diagnostic methods and the fact that timing of outcome measure was not clearly described. This paper provides Level IV evidence that in patients undergoing surgery for OVCF, preoperative hypoalbuminemia is associated with increased mortality at 2-years postoperatively. References 1. Gupta A, Upadhyaya S, Cha T, Schwab J, Bono C, Hershman S. Serum albumin levels predict which patients are at increased risk for complications following surgical management of acute osteoporotic vertebral compression fractures. Spine J. 2019;19(11):1796-1802. doi:10.1016/j.spinee.2019.06.023 2. Ohba T, Yokomichi H, Koyama K, Tanaka N, Oda K, Haro H. Factors affecting postoperative mortality of patients with insufficient union following osteoporotic vertebral fractures and impact of preoperative serum albumin on mortality. BMC Musculoskelet Disord. 2020;21(1):528. doi:10.1186/s12891-020-03564-z
There is insufficient evidence to make a recommendation regarding other patient or fracture characteristics affecting outcomes after surgical intervention for osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a retrospective comparative study, Isogai et al1 investigated the postoperative complications, and postoperative functional and radiographic outcomes, in patients who had fusion surgery for lower lumbar OVF with neurological deficits. The authors concluded that “surgical intervention for OVF is effective in patients with myelopathy or radiculopathy regardless of the surgical level.” The work group downgraded this potential Level III paper due to the diagnostic methods not being described. This paper provides Level IV evidence that in patients undergoing surgical treatment of OVCF, those with lower lumbar fractures compared to thoracolumbar junction fractures have higher rates of postoperative mechanical failure (instrumentation failure, cage subsidence or fracture at upper instrumented vertebrae (UIV)/lowest instrumented vertebrae (LIV). In a retrospective comparative study, Maruo et al2 evaluated the prevalence and effect of TPTD on consecutive VFs after long-instrumented fusion surgery for OVFs. The authors concluded that “pre- and postoperative TPTD treatment significantly reduced the incidence of subsequent VFs after instrumented fusion surgery for OVFs.” The work group downgraded this potential Level III paper due to small sample size and diagnostic methods not being described. This paper provides Level IV evidence that for patients undergoing surgery for OVCF, the use of teriparatide in the perioperative setting reduces the incidence of subsequent OVCFs compared to bisphosphonate treatment. In a retrospective case control study, Murata et al3 aimed to determine the prognostic factors for postoperative function in ADL despite differences seen between bedridden/chair bound patients and walkers. The authors concluded that “preoperative neurological deficit, perioperative complication, and absence of postoperative rPTH administration were considered as predictors for postoperative poor ADL in patients with OVF. Neurological deficits and complications are often inevitable factors; therefore, rPTH is an important option for postoperative treatment for OVF.” The work group downgraded this potential Level III paper due to unclear methodological concerns regarding rPTH administration. This paper provides Level IV evidence that for patients undergoing surgery for OVCF, the presence of a preoperative neurological deficit (Level III) or perioperative complication (Level III) or the absence of postoperative rPTH administration (Level IV) is associated with chair bound or bedridden functional status postoperatively.
In a retrospective observational study, Tamai et al4 studied independent risk factors and incidence of PJFr in patients following surgical treatment for osteoporotic vertebral collapse. The authors concluded that “PJFr was found in 16% [of] cases within 4 years after surgery; independent risk factors were severe osteoporosis and extended fusion to the sacrum. The lumbar BMD with cut-off value 0.61 g/cm2 may potentially predict PJFr. Our findings can help surgeons select perioperative adjuvant therapy, as well as a surgical strategy to prevent PJFr following surgery.” The work group downgraded this potential Level III paper due to the diagnostic methods not being described. This paper provides Level IV evidence that for patients undergoing instrumented fusion for osteoporotic fracture with a neurologic deficit, the following characteristic is associated with PJFr: severe baseline osteoporosis (based on a qualitative radiographic assessment). In addition, lumbar BMD rather than hip BMD is predictive of PJFr. References 1. Isogai N, Hosogane N, Funao H, et al. The Surgical Outcomes of Spinal Fusion for Osteoporotic Vertebral Fractures in the Lower Lumbar Spine with a Neurological Deficit. Spine Surg Relat Res. 2020;4(3):199-207. Published 2020 Jan 29. doi:10.22603/ssrr.2019-0079 2. Maruo K, Tachibana T, Arizumi F, Kusuyama K, Kishima K, Yoshiya S. Effect of Teriparatide on Subsequent Vertebral Fractures after Instrumented Fusion Surgery for Osteoporotic Vertebral Fractures with Neurological Deficits. Asian Spine J. 2019;13(2):283-289. doi:10.31616/asj.2018.0098 3. Murata K, Matsuoka Y, Nishimura H, et al. The factors related to the poor ADL in the patients with osteoporotic vertebral fracture after instrumentation surgery. Eur Spine J. 2020;29(7):1597-1605. doi:10.1007/s00586-019-06092-0. 4. Tamai K, Terai H, Suzuki A, et al. Risk Factors for Proximal Junctional Fracture Following Fusion Surgery for Osteoporotic Vertebral Collapse with Delayed Neurological Deficits: A Retrospective Cohort Study of 403 Patients. Spine Surg Relat Res. 2018;3(2):171-177. Published 2018 Oct 19. doi:10.22603/ssrr.2018-0068
FLASK Future Directions for Research
The work group recommends prognostic studies evaluating how specific clinical and fracture characteristics affect outcomes in patients with osteoporotic vertebral compression fractures undergoing surgical treatment, possibly through a prospective multicenter registry.
Surgical Treatment Question 6: In patients undergoing surgery for symptomatic osteoporotic vertebral compression fractures, are clinical and radiological outcomes affected by the types of implants used?
MMA screw augmentation may be considered as an option to reduce the risk of postoperative screw loosening in adults undergoing surgery for osteoporotic vertebral compression fractures.
Grade of Recommendation: C
In a retrospective comparative study, Girardo et al1 described the outcomes and complications of older adults with thoracolumbar vertebral fractures treated with 3 different types of screws: solid screws, cannulated screws and cannulated screws with PMMA augmentation. The authors concluded that “All stabilization methods showed good clinical results, but cannulated screws augmented with PMMA seem to provide better implant stability with the lowest rate of loosening. However, it must be considered that PMMA augmentation may cause severe complications such as death by embolism and adjacent level fractures.” This paper provides Level III evidence that in patients undergoing surgery for OVCF, the use of screw augmentation with PMMA results in lower rates of screw loosening with similar clinical outcomes compared to pedicle screw fixation without PMMA. The use of screw augmentation with PMMA is associated with the attendant risks of possible embolization and adjacent level fracture. In a retrospective comparative study, El Saman et al2 evaluated the postoperative loss of correction and loosening of pedicle screws in osteoporotic vertebral fractures found in older adults. The authors concluded that “The reinforcement of pedicle screws using PMMA augmentation may be a viable option in the surgical treatment of spinal fractures” in older adults. The work group downgraded this potential Level III paper due to nonconsecutive patients, small sample size, no validated outcome measures used, and a diagnostic method not stated. This paper provides Level IV evidence that in patients undergoing surgery for osteoporotic vertebral fractures, the use of PMMA screw augmentation reduces rates of screw loosening and provides a 3.8° reduction in loss of sagittal correction compared to pedicle screw fixation without PMMA. References 1. Girardo M, Rava A, Fusini F, Gargiulo G, Coniglio A, Cinnella P. Different pedicle osteosynthesis for thoracolumbar vertebral fractures in elderly patients. Eur Spine J. 2018;27(Suppl 2):198-205. doi:10.1007/s00586-018-5624-y 2. El Saman A, Meier S, Sander A, Kelm A, Marzi I, Laurer H. Reduced loosening rate and loss of correction following posterior stabilization with or without PMMA augmentation of pedicle screws in vertebral fractures in the elderly. Eur J Trauma Emerg Surg. 2013;39(5):455-460. doi:10.1007/s00068-013-0310-6
There is insufficient evidence to make a recommendation for or against the use of anterior vs posterior vs anterior plus posterior techniques in adults with neurological deficits undergoing surgery for osteoporotic vertebral compression fractures.
Grade of Recommendation: I
In a retrospective comparative study, Kashii et al1 compared the neurological recovery among 3 procedures for OVCF with neurological deficits: (1) anterior direct neural decompression and reconstruction (AR), (2) posterior spinal shorting osteotomy with direct neural decompression (PS), (3) posterior indirect neural decompression and short-segment spinal fusion combined with VP. The authors concluded that “Direct neural decompression is not always necessary, and the majority of patients can be treated with a less-invasive procedure such as short-segment posterior spinal fusion with indirect decompression combined with vertebroplasty. The high-priority issue is careful evaluation of patients’ general health and osteoporosis severity, so that the surgeon can choose the procedure best suited for each patient.” The work group downgraded this potential Level III paper due to the inconsistent application of treatments and significant differences in baseline characteristics between the treatment groups. This paper provides Level IV evidence that in patients with OVCF with neurological deficits undergoing surgical decompression and fixation, the use of anterior vs. posterior surgical approaches selected based on presenting characteristics results in similar clinical outcomes. Due to selection bias, the radiological differences between groups should be interpreted with caution. In a retrospective comparative study, Nakashima et al2 compared the surgical outcomes of anterior and posterior combined surgery (AP) versus posterior fixation with VP, for treating osteoporotic delayed vertebral collapse. The authors concluded “AP surgery provides stable spinal fixation and reduces implant failure particularly at the thoracolumbar junction because of load bearing of anterior spinal elements. Surgery-related complications in AP surgery were as few in number as with the VP group, and AP surgery is useful for osteoporotic delayed vertebral fracture.” The work group downgraded this potential Level III paper due to treatment allocation decisions not being specified and selection bias. This paper provides Level IV evidence that in patients undergoing surgery for progressive osteoporotic vertebral fractures, the use of anterior column reconstruction plus posterior fixation results in similar neurological outcomes with increased operative times and estimated blood loss (EBL) but reduced rates of pedicle screw loosening, pseudarthrosis and loss of correction compared to posterior fixation with VP. In a retrospective comparative study, Sudo et al3 examined the outcomes of anterior and posterior surgical procedures done for treating osteoporotic thoracolumbar vertebral collapse with neurological deficits. The authors concluded that “Anterior reconstruction for osteoporotic vertebral collapse is significant because anterior elements, particularly those at the thoracolumbar junction, play a major role in load bearing. However, difficulties arise when anterior reconstruction is performed in cases with very low bone density and in those with multiple vertebral collapse.” The work group downgraded this potential Level III paper due to small sample size and experience bias. This paper includes Level IV evidence that in patients undergoing surgery for progressive osteoporotic vertebral fractures, the use of anterior column reconstruction plus posterior fixation results in similar neurological outcomes with increased operative times and EBL but reduced rates of pedicle screw loosening, pseudarthrosis and loss of correction compared to posterior fixation with vertebroplasty. In a retrospective comparative study, Uchida et al4 evaluated 3 surgical procedures for osteoporotic vertebral collapse associated with neurological deficits in the thoracolumbar spine: (1) posterior surgery combined with vertebroplasty, (2) posterior surgery without vertebroplasty, (3) anterior surgery. The authors concluded that “Vertebroplasty using (calcium phosphate cement) CPC or (hydroxyapatite) HA materials supports and maintains kyphosis correction, and also increases and maintains anterior vertebral height in short-segment PS fixation performed in patients with thoracolumbar osteoporotic vertebral collapse.” The work group downgraded this potential Level III paper due to inconsistent application of treatment across groups. This paper includes Level IV evidence that in patients with neurological deficits undergoing posterior short segment fixation for OVCF, the addition of vertebral augmentation to the fractured level reduces rates of postoperative loss of correction as well as instrumentation failure. References 1. Kashii M, Yamazaki R, Yamashita T, et al. Surgical treatment for osteoporotic vertebral collapse with neurological deficits: retrospective comparative study of three procedures—anterior surgery versus posterior spinal shorting osteotomy versus posterior spinal fusion using vertebroplasty. Eur Spine J. 2013;22:1633-1642. 2. Nakashima H, Imagama S, Yukawa Y, et al. Comparative study of 2 surgical procedures for osteoporotic delayed vertebral collapse: anterior and posterior combined surgery versus posterior spinal fusion with vertebroplasty. Spine (Phila Pa 1976). 2015;40(2):E120-E126. doi:10.1097/BRS.0000000000000661 3. Sudo H, Ito M, Kaneda K, et al. Anterior decompression and strut graft versus posterior decompression and pedicle screw fixation with vertebroplasty for osteoporotic thoracolumbar vertebral collapse with neurologic deficits. Spine J. 2013;13(12):1726-1732. doi:10.1016/j.spinee.2013.05.041 4. Uchida K, Nakajima H, Yayama T, et al. Vertebroplastyaugmented short-segment posterior fixation of osteoporotic vertebral collapse with neurological deficit in the thoracolumbar spine: comparisons with posterior surgery without vertebroplasty and anterior surgery. J Neurosurg Spine. 2010;13: 612-6
FLASK Future Directions for Research
The work group recommends prognostic studies evaluating how specific surgical implant type and surgical approaches affect outcomes in patients with osteoporotic vertebral compression fractures undergoing surgical treatment, possibly through a prospective multicenter registry.