| Coverage Policy Manual | |
| Policy #: | 1999012 |
| Category: | Medicine |
| Initiated: | June 1999 |
| Last Review: | May 2024 |
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| Minimally Invasive Approaches to Vertebral Fractures and Osteolytic Lesions of the Spine (Vertebroplasty, Sacroplasty, Kyphoplasty, and Mechanical Vertebral Augmentation) | |
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| Description: |
Percutaneous vertebroplasty, percutaneous balloon kyphoplasty, radiofrequency kyphoplasty, and mechanical vertebral augmentation are interventional techniques involving the fluoroscopically guided injection of polymethylmethacrylate (PMMA) into a weakened vertebral body or a cavity created in the vertebral body with a balloon or mechanical device. The techniques have been investigated to provide mechanical support and symptomatic relief in patients with osteoporotic vertebral compression fractures or those with osteolytic lesions of the spine (e.g., multiple myeloma, metastatic malignancies); as a treatment for sacral insufficiency fractures; and as a technique to limit blood loss related to surgery.
Treatment of Vertebral Compression Fracture
Chronic symptoms do not tend to respond to the management strategies for acute pain such as bed rest, immobilization/bracing device, and analgesic medication, sometimes including narcotic analgesics. The source of chronic pain after vertebral compression fracture may not be from the vertebra itself but may be predominantly related to strain on muscles and ligaments secondary to kyphosis. This type of pain frequently does not improve with analgesics and may be better addressed through exercise or physical therapy. Improvements in pain and ability to function are the principal outcomes of interest for the treatment of osteoporotic fracture.
Treatment of Sacral Insufficiency Fractures
Similar interventions are used for sacral fractures and include bed rest, bracing, and analgesics. Initial clinical improvements may occur quickly; however, resolution of all symptoms may not occur for 9 to 12 months (Gotis-Graham, 1994; Lin, 2001).,
Vertebral and Sacral Body Metastasis
Metastatic malignant disease of the spine generally involves the vertebrae/sacrum, with pain being the most frequent complaint.
Vertebral and Sacral Body Metastasis
While radiation and chemotherapy are frequently effective in reducing tumor burden and associated symptoms, pain relief may be delayed days to weeks, depending on tumor response. Further, these approaches rely on bone remodeling to regain strength in the vertebrae/sacrum which may necessitate supportive bracing to minimize the risk of vertebral/sacral collapse during healing. Improvements in pain and function are the primary outcomes of interest for treatment of bone malignancy with percutaneous vertebroplasty or sacroplasty.
Treatment of Vertebral and Sacral Body Metastasis
While radiotherapy and chemotherapy are frequently effective in reducing tumor burden and associated symptoms, pain relief may be delayed days to weeks, depending on tumor response. Further, these approaches rely on bone remodeling to regain strength in the vertebrae/sacrum, which may necessitate supportive bracing to minimize the risk of vertebral/sacral collapse during healing. Improvements in pain and function are the primary outcomes of interest for treatment of bone malignancy with percutaneous vertebroplasty or sacroplasty.
Surgical Treatment Options
Percutaneous Vertebroplasty
Vertebroplasty is a surgical procedure that involves the injection of synthetic cement (e.g., polymethylmethacrylate, bis-glycidal dimethacrylate [Cortoss]) into a fractured vertebra (Bae, 2012). It has been suggested that vertebroplasty may provide an analgesic effect through mechanical stabilization of a fractured or otherwise weakened vertebral body. However, other mechanisms of effect have been postulated, including thermal damage to intraosseous nerve fibers.
Balloon kyphoplasty is a variant of vertebroplasty and uses a specialized bone tamp with an inflatable balloon to expand a collapsed vertebral body as close as possible to its natural height before injection of polymethyl methacrylate. Radiofrequency kyphoplasty (also known as radiofrequency targeted vertebral augmentation) is a modification of balloon kyphoplasty. In this procedure, a small diameter articulating osteotome creates paths across the vertebra. An ultra-high viscosity cement is injected into the fractured vertebral body, and radiofrequency is used to achieve the desired consistency of the cement. The ultra-high viscosity cement is designed to restore height and alignment to the fractured vertebra, along with stabilizing the fracture.
Percutaneous Sacroplasty
Sacroplasty evolved from the treatment of insufficiency fractures in the thoracic and lumbar vertebrae with vertebroplasty. The procedure, essentially identical to vertebroplasty, entails guided injection of polymethylmethacrylate through a needle inserted into the fracture zone. Although first described in 2000 as a treatment for symptomatic sacral metastatic lesions, it is most often described as a minimally invasive alternative to conservative management, for sacral insufficiency fractures (Dehdashti, 2000; Marcy, 2000; Aretxabala, 2000; Leroux, 1993; Newhouse, 1992).
Mechanical Vertebral Augmentation
Kiva is a mechanical vertebral augmentation technique that uses an implant for structural support of the vertebral body to provide a reservoir for bone cement. The Kiva vertebral compression fractures treatment system consists of a shaped memory coil and an implant, which is filled with bone cement. The coil is inserted into the vertebral body over a removable guide wire. The coil reconfigures itself into a stack of loops within the vertebral body and can be customized by changing the number of loops of the coil. The implant, made from PEEK-OPTIMA, a biocompatible polymer, is deployed over the coil. The coil is then retracted, and polymethyl methacrylate is injected through the lumen of the implant. The polymethyl methacrylate cement flows through small slots in the center of the implant, which fixes the implant to the vertebral body and contains the polymethyl methacrylate in a cylindrical column. The proposed advantage of the Kiva system is a reduction in cement leakage.
SpineJack is a mechanical vertebral augmentation technique that utilizes bipedicular 4.2 mm to 5.0 mm self-expanding jacks to restore vertebral height. Placement of the titanium devices are verified in anteroposterior and lateral view prior to expansion. Once the devices are expanded, a proprietary bone cement is injected. The proposed benefit is greater control over expansion and greater restoration of vertebral height compared to balloon kyphoplasty. The procedure requires good bone quality.
Pain and function are subjective outcomes and, thus, may be susceptible to placebo effects. Furthermore, the natural history of pain and disability associated with these conditions may vary. Therefore, controlled comparison studies would be valuable to demonstrate the clinical effectiveness of vertebroplasty and sacroplasty over any associated nonspecific or placebo effects and to demonstrate the effect of treatment compared with alternatives such as continued medical management.
In all clinical situations, adverse events related to complications from vertebroplasty, kyphoplasty, sacroplasty, and mechanical vertebral augmentation are the primary harms to be considered. Principal safety concerns relate to the incidence and consequences of leakage of the injected polymethyl methacrylate or another injectate.
Regulatory Status
Vertebroplasty is a surgical procedure and, as such, is not subject to U.S. Food and Drug Administration (FDA) approval.
Polymethylmethacrylate bone cement was available as a drug product before enactment of the FDA's device regulation and was at first considered what the FDA terms a "transitional device." It was transitioned to a class III device requiring premarketing applications. Several orthopedic companies have received approval of their bone cement products since 1976. In 1999, polymethylmethacrylate was reclassified from class III to class II, which requires future 510(k) submissions to meet "special controls" instead of "general controls" to assure safety and effectiveness. Thus, use of polymethylmethacrylate in vertebroplasty represented an off-label use of an FDA-regulated product before 2005. In 2005, polymethylmethacrylate bone cements such as Spine-Fix® Biomimetic Bone Cement and Osteopal® V were cleared for marketing by the FDA through the 510(k) process for the fixation of pathologic fractures of the vertebral body using vertebroplasty procedures.
The use of polymethylmethacrylate in sacroplasty is an off-label use of an FDA-regulated product (bone cements such as Spine-Fix Biomimetic Bone Cement [Teknimed] and Osteopal V [Heraeus]) because the 510(k) approval was for the fixation of pathologic fractures of the vertebral body using vertebroplasty procedures. Sacroplasty was not included. FDA product code: NDN.
In 2009, Cortoss (Stryker) Bone Augmentation Material was cleared for marketing by the FDA through the 510(k) process. Cortoss is a nonresorbable synthetic material that is a composite resin-based, bis-glycidyl dimethacrylate. The FDA classifies this product as a polymethylmethacrylate bone cement.
In 2010, the Parallax Contour Vertebral Augmentation Device (ArthroCare) was cleared for marketing by FDA through the 510(k) process. There have been several other augmentation and bone expander devices (e.g., Balex Bone Expander System, Arcadia Ballon Catheter, Kyphon Element Inflatable Bone Tamp) that were also cleared for marketing by FDA through the 510(k) process. These devices create a void in cancellous bone that can then be filled with bone cement. FDA product code: HXG.
Kyphoplasty is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration (FDA). Polymethyl methacrylate bone cement was available as a drug product before enactment of the FDA's device regulation and was at first considered what the FDA termed a "transitional device." It was transitioned to a class III device and then to a class II device, which required future 510(k) submissions to meet "special controls" instead of "general controls" to assure safety and effectiveness. In July 2004, KyphX HV-RTM bone cement was cleared for marketing by the FDA through the 510(k) process for the treatment of pathologic fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty procedure. Subsequently, other products such as Spine-Fix Biomimetic Bone Cement, KYPHON HV-R Bone Cement, KYPHON VuE Bone Cement, and Osteopal V (Heraeus) have received 510(k) marketing clearance for the fixation of pathologic fractures of the vertebral body using vertebroplasty or kyphoplasty procedures.
Balloon kyphoplasty requires the use of an inflatable bone tamp. In July 1998, one such tamp, the KyphX inflatable bone tamp (Medtronic), was cleared for marketing by the FDA through the 510(k) process. Additional devices for balloon kyphoplasty are listed below.
There are several mechanical vertebral augmentation devices that have received marketing clearance by the FDA through the 510(k) process; these are listed in below.
StabiliT Vertebral Augmentation System (Merit Medical) for radiofrequency vertebral augmentation was cleared for marketing in 2009.
FDA product code: NDN.
Kyphoplasty and Mechanical Vertebral Augmentation Devices Cleared by the U.S. Food and Drug Administration:
Balloon Kyphoplasty
Mechanical Vertebral Augmentation
Coding
Effective in 2015, there are new CPT codes that combine the vertebroplasty procedure with all of the necessary imaging guidance:
22510: Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; cervicothoracic
22511: lumbosacral
22512: each additional cervicothoracic or lumbosacral vertebral body (List separately in addition to code for primary procedure
There are CPT category III codes for sacroplasty:
0200T: Percutaneous sacral augmentation (sacroplasty), unilateral injection(s), including the use of a balloon or mechanical device, when used, 1 or more needles
0201T: Percutaneous sacral augmentation (sacroplasty), bilateral injections, including the use of a balloon or mechanical device, when used, 2 or more needles
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Policy/ Coverage: |
Effective June 2024, coverage policies 1999012 (Vertebroplasty, Percutaneous), 2005031 (Sacroplasty), and 2003024 (Kyphoplasty, Percutaneous, Radiofrequency, and Mechanical Vertebral Augmentation) were combined into one policy. Policies 2005031 and 2003024 are archived effective June 2024.
Effective June 2024
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Percutaneous Vertebroplasty
Percutaneous vertebroplasty meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
Balloon Kyphoplasty
Balloon kyphoplasty meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
Mechanical Vertebral Augmentation
Mechanical vertebral augmentation with an FDA-cleared device meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
*Conservative treatment includes but is not limited to, initial bed rest with progressive activity, analgesics, physical therapy, bracing and exercises to correct postural deformity and increase muscle tone, bisphosphonates, and calcium supplementation.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Percutaneous Vertebroplasty
Percutaneous vertebroplasty for any other indications not listed above, including use in acute vertebral fractures due to osteoporosis or trauma, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, percutaneous vertebroplasty for any other indication not listed above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Percutaneous Sacroplasty
Percutaneous sacroplasty does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, percutaneous sacroplasty is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Kyphoplasty/Mechanical Vertebral Augmentation
Balloon kyphoplasty or mechanical vertebral augmentation with an FDA-cleared device for any other indication, including use in acute vertebral fractures due to osteoporosis or trauma, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, balloon kyphoplasty or mechanical vertebral augmentation with an FDA-cleared device for any other indication, including use in acute vertebral fractures due to osteoporosis or trauma, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Radiofrequency kyphoplasty does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency kyphoplasty is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Mechanical vertebral augmentation using any other device does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, mechanical vertebral augmentation using any other device is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective August 2019 to May 2024
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Primary coverage criteria is met for vertebroplasty for the following indications:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Vertebroplasty for any other condition not noted above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes:
For contracts without Primary Coverage Criteria, vertebroplasty for patients for any other condition not noted above as meeting Primary Coverage Criteria is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
Effective Prior to August 2019
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Primary coverage criteria is met for vertebroplasty for the following indications:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Vertebroplasty for any other condition not noted above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes:
For contracts without Primary Coverage Criteria, vertebroplasty for patients for any other condition not noted above as meeting Primary Coverage Criteria is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
Effective Prior to May 2017
Primary coverage criteria is met for vertebroplasty for the following indications:
Vertebroplasty for any other condition not noted above does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness.
For contracts without Primary Coverage Criteria, vertebroplasty for patients for any other condition not noted above as meeting Primary Coverage Criteria is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
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| Rationale: |
This evidence review is regularly updated with searches of the PubMed database. The most recent literature update was performed through February 16, 2024.
Percutaneous Vertebroplasty for Vertebral Compression Fractures of Between 6 Weeks and 1 Year Old
Osteoporotic compression fractures are common. It is estimated that up to one-half of women and approximately one-quarter of men will have a vertebral fracture at some point in their lives. However, only about one-third of vertebral fractures reach clinical diagnosis, and most symptomatic fractures will heal within a few weeks or 1 month with medical management. Nonetheless, some individuals with acute fractures will have severe pain and decreased function that interferes with the ability to ambulate and is not responsive to usual medical management. Also, a minority of patients will exhibit chronic pain following osteoporotic compression fracture that presents challenges for medical management.
The purpose of vertebroplasty is to provide a treatment option that is an alternative to or an improvement on existing therapies in individuals with symptomatic osteoporotic or osteolytic vertebral fractures between 6 weeks and 1 year old.
Systematic Reviews
Buchbinder et al published a Cochrane review of the literature up to November 2014 (Buchbinder, 2018). Studies compared vertebroplasty versus placebo (2 studies with 209 randomized participants), usual care (6 studies with 566 randomized participants), and kyphoplasty (4 studies with 545 randomized participants). The majority of participants were female, between 63.3 and 80 years of age, with symptom duration ranging from 1 week to more than 6 months. At 1 month, disease-specific quality of life measured by the QUALEFFO (a quality of life questionnaire in patients with vertebral fractures; scale 0 to 100, higher scores indicating worse quality of life) was 0.40 points worse in the vertebroplasty group. Based upon moderate quality evidence from 3 trials (1 placebo, 2 usual care, 281 participants) with up to 12 months follow-up, it is unclear if vertebroplasty increases the risk of new symptomatic vertebral fractures. Similarly, based upon moderate quality evidence from 2 placebo-controlled trials, it is unclear to what extent risk of other adverse events exists. There were 3/106 adverse events observed in the vertebroplasty group compared with 3/103 in the placebo group (risk ratio[RR], 1.01; 95% confidence interval [CI]: 0.21 to 4.85). Serious adverse events that have been reported with vertebroplasty included osteomyelitis, cord compression, thecal sac injury, and respiratory failure.
Staples et al conducted a patient-level meta-analysis of the 2 sham-controlled trials to determine whether vertebroplasty is more effective than sham in specific subsets of patients (Staples, 2011). This subset analysis focused on duration of pain (6 weeks or less vs. more than 6 weeks) and severity of pain (score less than 8 or 8 or more on an 11-point numeric rating scale). The analysis included 209 participants (78 from the Australian trial, 131 from the U.S. trial); 27% had pain of recent onset and 47% had severe pain at baseline. The primary outcome measures (pain scores and function on the RMDQ at 1 month) did not differ significantly between groups. Responder analyses were also conducted based on a 3-unit improvement in pain scores, a 3-unit improvement in RMDQ scores, and a 30% improvement in each of the pain and disability outcomes. The only difference observed between groups was a trend in the vertebroplasty group to achieve at least 30% improvement in pain scores (RR, 1.32; 95% CI, 0.98 to 1.76; p=.07), a result that may have been confounded by the greater use of opioid medications in that group.
Xie et al, in a meta-analysis of RCTs, evaluated the efficacy and safety in percutaneous vertebroplasty and conservative treatment for patients with osteoporotic vertebral compression fractures (Xie, 2017). Thirteen studies were selected (N=1231 patients; 623 to vertebroplasty, 608 to conservative treatment). Outcomes included pain relief (from 1 week to 6 months), quality of life assessments, and the rate of adjacent-level vertebral fracture. Vertebroplasty was superior for pain relief at 1 week and at 1 month. It was inferior to conservative treatment for pain relief at 6 months. Vertebroplasty showed improvement over conservative treatment for quality of life, as measured using QUALEFFO. No statistically significant differences were found between treatments for the rate of adjacent-level vertebral fractures. Limitations included the inclusion of several studies with inadequate blinding and heterogenous reporting of patient characteristics outcomes.
Hinde et al, in a meta-analysis of retrospective and prospective cohort studies, assessed the mortality outcomes of vertebral augmentation versus nonsurgical management in patients with osteoporotic vertebral compression fractures (Hinde, 2020). The meta-analysis included 7 studies (N=2,089,944; 382,070 treated with vertebral augmentation and 1,707,874 treated with nonsurgical management). Vertebral augmentation improved mortality compared with nonsurgical management at both 2- and 5-year follow-up. Limitations included heterogeneity in the number of enrolled patients in included studies as well as differences in health status.
Zhang et al, in a meta-analysis of RCTs, assessed the efficacy of percutaneous vertebroplasty versus conservative treatment for patients with osteoporotic vertebral compression fractures (Zhang, 2020). Ten studies were included, and outcomes consisted of pain relief at 1 week, 1 month, and 6 months; quality of life assessments; and the rate of new vertebral fractures. Compared with conservative treatment, percutaneous vertebroplasty was superior for pain relief at 1 week and 1 month, but not at 3 months. Results varied for quality of life assessments with similar outcomes between percutaneous vertebroplasty and conservative treatments on the RMDQ. Limitations included an imbalance in baseline demographics and the clinical characteristics of patients in included studies.
Chang et al, in a meta-analysis of RCTs and cohort studies, evaluated the effectiveness and safety of various interventions, including vertebroplasty versus kyphoplasty or conservative treatment, for treating osteoporotic vertebral compression fractures (Chang, 2021). Thirty-nine studies included vertebroplasty as a comparative arm. Outcomes included scores based on the VAS and Oswestry Disability Index (ODI). Vertebroplasty decreased scores on the VAS and ODI compared with conservative treatment, but had similar outcomes compared with kyphoplasty. The rate of new fractures was similar for vertebroplasty versus conservative treatment and vertebroplasty versus kyphoplasty. Limitations consisted of the differences in indications, data types, follow-up times, and variables in included studies.
A network meta-analysis of RCTs conducted by Liu et al assessed the safety and efficacy of 12 interventions, including vertebroplasty, compared to conventional and sham treatments for osteoporotic vertebral compression fractures (Liu, 2023). The analysis included 34 RCTs, encompassing a total of 4383 participants with an average age of 73.4 years. Each study required a control group and an intervention group and reported on outcomes measured by the VAS pain scale or the ODI. The authors included several subgroups of vertebroplasty (vertebroplasty with facet joint injection, unilateral vertebroplasty, and curved vertebroplasty), which are not discussed here. Improvements compared to conservative treatment were observed in both short-term and long-term VAS and ODI scores. Compared to sham treatment, no significant difference was noted in short-term VAS scores; however, a notable improvement favoring the vertebroplasty group was observed in long-term VAS outcomes, as well as in both short-term and long-term ODI outcomes. No significant differences were observed in the relative risk of new fractures between vertebroplasty and the sham or conservative control groups. Limitations consisted of differences in indications and follow-up times, significant heterogeneity across study findings, and more than 50% of included studies having been assessed with a moderate or high risk of bias.
Randomized Controlled Trials
Vertebroplasty Versus Medical Management With Sham Controls
Three sham-controlled trials compared vertebroplasty with medical management using a sham control (that included local anesthetic), which mimicked the vertebroplasty procedure up to the point of cement injection (Buchbinder, 2009; Kallmes, 2009). Buchbinder et al reported on results for a 4-center, randomized, double-blind, sham-controlled trial with 78 patients with 1 or 2 painful osteoporotic vertebral fractures with a duration of less than 1 year (Buchbinder, 2009). Patients were assigned to vertebroplasty or sham procedure (i.e., injection of local anesthetic into the facet capsule and/or periosteum). Ninety-one percent of participants completed 6 months of follow-up. The participants, investigators (other than the radiologists performing the procedure), and outcome assessors were blinded to the treatment assignment. Kroon et al reported results of the same trial at 12 and 24 months, maintaining blinding throughout the follow-up period (Kroon, 2014). The primary outcome was overall pain measured on a VAS from 0 to 10, with 1.5 points representing the minimal clinically important difference. For the primary outcome, reviewers reported no significant differences in VAS pain score at 3, 12, or 24 months. With reductions in pain and improvements in quality of life observed in both groups, the authors concluded routine use of vertebroplasty provided no benefit.
Kallmes et al conducted a multicenter, randomized, double-blind, sham-controlled, investigational vertebroplasty safety and efficacy trial in which 131 participants with 1 to 3 painful osteoporotic vertebral fractures were assigned to vertebroplasty or sham procedure (injection of local anesthetic into the facet capsule and/or periosteum) (Kallmes, 2009). Participants had back pain for no more than 12 months and had a current pain rating of at least 3 on VAS at baseline. Participants were evaluated at various time points to 1 year postprocedure. Ninety-seven percent completed a 1-month follow-up; 95% completed 3 months. The primary outcomes were RMDQ scores and average back pain intensity during the preceding 24 hours at 1 month, with a reduction of 30% in RMDQ and VAS pain scores considered a clinically meaningful difference (Ostelo, 2008).
For the primary endpoints at 1 month, there were no significant between-group differences. There was a trend toward a higher clinically meaningful improvement in pain at 1 month (30% reduction from baseline) in the vertebroplasty group (64% vs. 48%, respectively; p=.06). At 3 months, 51% from the control group and 13% in the vertebroplasty group crossed over (p<.001). Comstock et al reported on patient outcomes at 1 year, at which point 16% of patients who underwent vertebroplasty and 60% of control subjects had crossed over to the alternative procedure (p<.001) (Comstock, 2013). The as-treated analysis found no significant difference in RMDQ or pain scores between the 2 groups. Intention-to-treat analysis found a modest 1-point difference in pain rating and no significant difference in RMDQ score. There was a significant difference in the percentage of patients showing a 30% or greater improvement in pain (70% of patients randomized to vertebroplasty vs. 45% of patients randomized to the control group). One limitation of this study is that at 14 days, 63% of patients in the control group correctly guessed they had the control intervention, and 51% of patients in the vertebroplasty group correctly guessed they had the vertebroplasty.
Firanescu et al published the results of a randomized, double-blind, sham-controlled clinical trial performed in 4 community hospitals in the Netherlands from 2011 to 2015 (Firanescu, 2018). The main outcome measured was mean reduction in VAS scores at 1 day, 1 week, and 1, 3, 6, and 12 months. The mean reduction in VAS score was statistically significant in the vertebroplasty and sham procedure groups at all follow-up points after the procedure compared with baseline. These changes in VAS scores were not statistically significant between the groups during 12 months of follow-up.
Vertebroplasty Versus Medical Management Without Sham Controls
Chen et al reported on a nonblinded RCT comparing vertebroplasty with conservative management (Chen, 2014). The trial included 89 patients with chronic compression fractures confirmed by magnetic resonance imaging and persistent severe pain for 3 months or longer. The evaluation was performed at 1 week and 1, 3, 6, and 12 months. Over the course of 1 year, pain scores decreased from 6.5 to 2.5 in the vertebroplasty group and from 6.4 to 4.1 in the control group (p<.001). Complete pain relief was reported by 84.8% of patients in the vertebroplasty group and 34.9% of controls. The final ODI score was 15.0 in the vertebroplasty group and 32.1 in the conservative management group (p<.001), and the final RMDQ score was 8.1 for vertebroplasty and 10.7 for controls (p<.001).
Farrokhi et al reported on a blinded RCT that compared vertebroplasty with optimal medical management in 82 patients (Farrokhi, 2011). Patients had painful osteoporotic vertebral compression fractures that were refractory to analgesic therapy for at least 4 weeks and less than 1 year. Control of pain and improvement in quality of life were measured by independent raters before treatment and at 1 week and 2, 6, 12, 24, and 36 months after treatment began. Radiologic evaluation to measure vertebral body height and correction of deformity was performed before and after treatment and after 36 months of follow-up. Adverse events include new symptomatic adjacent fractures in 1 patient in the treatment group and 6 in the control group. Additionally, 1 patient experienced epidural cement leakage, which caused severe lower extremity pain and weakness, and had to be treated with bilateral laminectomy and evacuation of the bone cement.
Nonrandomized Comparative Studies
Edidin et al reported on mortality risk rates in Medicare patients who had vertebral compression fractures and were treated with vertebroplasty, kyphoplasty, or nonoperatively (Edidin, 2011; Edidin, 2015). These studies were industry funded. In the 2015 report, they identified 1,038,956 patients who had vertebral compression fractures between 2005 and 2009. The dataset included 141,343 kyphoplasty patients and 75,364 vertebroplasty patients. The matched cohort included 100,649 nonoperated patients, 36,657 kyphoplasty patients, and 24,313 vertebroplasty patients. Survival was calculated from the index diagnosis date until death or the end of follow-up (up to 4 years). Analysis of the whole data set before matching indicated that patients in the nonoperated cohort had a 55% (95% CI, 53% to 56%; p<.001) higher risk of mortality than the kyphoplasty cohort and a 25% (95% CI, 23% to 26%; p<.001) higher mortality risk than the vertebroplasty cohort. After propensity matching, the risk of mortality at 4 years was 47.2% in the nonoperated group compared with 42.3% in the kyphoplasty group (p<.001) and 46.2% in the vertebroplasty group (p<.001).
Lin et al reported on mortality risk in elderly patients (older than 70 years old) who had vertebral compression fractures and were treated with early vertebroplasty (within 3 months) or conservative therapy (Lin, 2017). The data set consisted of 10,785 Taiwanese patients who were selected through the National Health Insurance Research Database, of whom 1773 patients received vertebroplasty, and 5324 did not; a minority of these patients had osteoarthritis. The authors found that a "significant difference in survival curves of mortality and respiratory failure" existed between both groups of patients (p<.05). The incidence of death at 1 year in the vertebroplasty group was 0.46 per 100 person-months (95% CI, 0.38 to 0.56). The incidence of death at 1 year in the nonvertebroplasty group was 0.63 per 100 person-months (95% CI, 0.57 to 0.70). With regard to respiratory failure, hazard ratio (HR) between groups was 1.46 (95% CI, 1.04 to 2.05; p=.028). Limitations of this study included the broad selection of the population, which was not restricted only to patients with osteoporotic lesions. Also, authors were limited by the database, which did not report on pain or functional outcomes.
Percutaneous Vertebroplasty for Vertebral Compression Fractures of Less Than 6 Weeks Old
Randomized Controlled Trials
Vertebroplasty Versus Medical Management With Sham Controls
Clark et al reported on results from the Safety and Efficacy of Vertebroplasty of Acute Painful Osteoporotic Fractures (VAPOUR) trial (Clark, 2016). VAPOUR was a multicenter, double-blind trial of vertebroplasty in 120 patients with vertebral fractures of less than 6 weeks in duration and back pain of at least 7 out of 10 on a numeric rating scale. This trial followed a similar protocol as that used in the 2009 Kallmes et al trial (discussed above). The primary outcome (the percentage of patients with a numeric rating scale score less than 4 out of 10 at 14 days postprocedure) was met in a greater percentage of patients in the vertebroplasty group (44%) than in the sham control group (21%). This between-group difference was maintained through 6 months.
Other outcome measures were significantly improved in the vertebroplasty group at 1 or both of the time points. The benefit of vertebroplasty was found predominantly in the thoracolumbar subgroup, with 48% (95% CI, 27% to 68%) more patients meeting the primary endpoint (61% in the vertebroplasty group vs. 13% in the control group). The investigators commented that the thoracolumbar junction is subject to increased dynamic load, and fractures at this junction have the highest incidence of mobility. No benefit from vertebroplasty was found in the non-thoracolumbar subgroup. Postprocedural hospital stay was reduced from a mean of 14 days in the control group to 8.5 days after vertebroplasty, even though physicians who determined the discharge date remained blinded to treatment. In the vertebroplasty group, there were 2 serious adverse events due to sedation and transfer to the radiology table. In the control group, 2 patients developed spinal cord compression; 1 underwent decompressive surgery and the other, not a surgical candidate, became paraplegic.
Vertebroplasty Versus Medical Management Without Sham Controls
Klazen et al reported on the vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures, an open-label randomized trial of 202 patients at 6 hospitals in the Netherlands and Belgium (Klazen, 2010). Of 431 patients eligible for randomization, 229 (53%) had spontaneous pain relief during assessment. Participants with at least 1 painful osteoporotic vertebral fracture of 6 weeks or less in duration were assigned to vertebroplasty or conservative management. The primary outcome was pain relief of 3 points measured on a 10-point VAS at 1 month and 1 year.
A total of 101 subjects were enrolled in the treatment group and the control arm; 81% completed 12-month follow-up. There were no significant differences in the primary outcome (pain relief of 3 points) measured at 1 month and 1 year. Vertebroplasty resulted in greater pain relief than did medical management through 12 months (p<.001); there were significant between-group differences in mean VAS scores at 1 month or at 1 year. Survival analysis showed significant pain relief was quicker (29.7 days vs. 115.6 days) and was achieved by more patients after vertebroplasty than after conservative management.
Yi et al assessed the occurrence of new vertebral compression fractures after treatment with cement augmenting procedures (vertebroplasty or kyphoplasty) versus conservative treatment in an RCT with 290 patients (363 affected vertebrae) (Yi, 2014). Patients treated conservatively had a mean length of stay of 13.7 days. Return to usual activity occurred at 1 week for 87.6% of operatively treated patients and 2 months for 59.2% of conservatively treated patients. All patients were evaluated with radiographs and magnetic resonance imaging at 6 months and then at yearly intervals until the last follow-up session. At a mean follow-up of 49.4 months (range, 36-80 months), 10.7% of patients had experienced 42 new symptomatic vertebral compression fractures. There was no significant difference in the incidence of new vertebral fractures between the operative (18 total; 9 adjacent, 9 nonadjacent) and conservative (24 total; 5 adjacent, 16 nonadjacent, 3 same level) groups but the mean time to a new fracture was significantly shorter in the operative group (9.7 months) than in the nonoperative group (22.4 months).
Leali et al published a brief report on a multicenter RCT enrolling 400 patients with osteoporotic thoracic or lumbar vertebral compression fractures who were treated with vertebroplasty or conservative therapy (Leali, 2016). Fractures were treated within 2 weeks of pain onset. Details of randomization and rates of follow-up were not reported. At 1 day after treatment, the vertebroplasty group had a reduction in pain scores and improvement in physical function, with VAS pain scores decreasing from 4.8 (maximum, 5.0) to 2.3 (p=.023) and ODI scores improving from 53.6% to 31.7% (p=.012). Sixty-five percent of patients treated with vertebroplasty had stopped all analgesic use within 48 hours. The conservatively managed group showed no benefit in the first 48 hours, but by 6 weeks VAS and ODI scores were described as similar in both groups (specific data not reported). Evaluation of this trial was limited by incomplete reporting.
Yang et al compared vertebroplasty with conservative therapy in 135 patients over 70 years of age with severe back pain due to an osteoporotic vertebral fracture after minor or mild trauma (Yang, 2016). Vertebroplasty was performed at a mean of 8.4 days after pain onset. Patients in the conservative therapy group were placed on bed rest and analgesics for at least 2 weeks after diagnosis, followed by bracing and assistive devices. All patients receiving vertebroplasty could stand and walk with a brace at 1 day posttreatment, while only 12 (23.5%) patients in the control group could stand up and walk after 2 weeks of bed rest. The average duration of bed rest from pain onset was 7.8 days (range, 2-15 days) in the vertebroplasty group compared with 32.5 days (range, 14-60 days) in the conservative therapy group. At 1-year follow-up, there was a similar percentage of additional compression fractures but a significantly higher complication rate in the conservative therapy group (35.3%) than in the vertebroplasty group (16.1%; p<.001). Complications included pneumonia, urinary tract infection, deep vein thrombosis, depression, and sleep disorders.
Percutaneous Sacroplasty
Observational Studies
Sacroplasty is an evolving technique achieved using numerous methods (short-axis, long-axis, balloon-assisted short-axis, iliosacral screws). No randomized trials of sacroplasty were identified. Frey et al conducted the largest prospective observational cohort study, assessing 52 consecutive patients undergoing sacroplasty for sacral insufficiency fractures using the short-axis technique (Frey, 2008). Patients had a mean age of 75.9 years, mean duration of symptoms of 34.5 days (range, 4-89 days), and mean VAS score of 8.1 at baseline. Improvements in VAS scores were measured at 30 minutes and 2, 4, 12, 24, and 52 weeks postprocedure. At each interval, statistically significant improvements over baseline were observed and maintained through 52 weeks.
Kortman et al reported on the largest series, a retrospective multicenter analysis (Kortman, 2013). They evaluated 204 patients with painful sacral insufficiency fractures and 39 patients with symptomatic sacral lesions treated with the short-axis or long-axis technique. One hundred sixty-nine patients had bilateral sacral insufficiency fractures, and 65 patients had additional fractures of the axial skeleton. VAS scores improved from 9.2 before treatment to 1.9 after treatment in patients with sacral insufficiency fractures and from 9.0 to 2.6 in patients with sacral lesions. There was 1 case of radicular pain due to extravasation of cement requiring surgical decompression.
Frey et al reported on patients treated with percutaneous sacroplasty, particularly the long-term efficacy of sacroplasty versus nonsurgical management (Frey, 2017). This prospective, observational cohort study spanned 10 years and comprised 240 patients with sacral insufficiency fractures. Thirty-four patients were treated with nonsurgical methods, and 210 patients were treated with sacroplasty. Pain, as measured by VAS, was recorded before treatment and at several follow-ups. Mean pretreatment VAS for the sacroplasty group was 8.29; for the nonsurgical treatment group, it was 7.47. Both forms of treatment resulted in significant VAS improvement from pretreatment to the 2-year follow-up (p<.001). However, the sacroplasty treatment group experienced significant VAS score improvement consistently at many of the follow-up points (pretreatment to post [p<.001]; posttreatment through 2 weeks [p>.001]; 12 weeks through 24 weeks [p=.014]; 24 weeks through 1 year [p=.002]). Meanwhile, the group with nonsurgical treatment only experienced 1 significant pain improvement score, which was at the 2-week follow-up posttreatment (p=.002). One major limitation of this study was that the nonsurgical treatment group was not followed up at the 10-year mark whereas the sacroplasty group did receive follow-up.
Beall and colleagues published interim findings on patients who underwent percutaneous sacroplasty (Beall, 2023). These patients were part of a prospective registry study conducted across multiple centers, which aimed to assess the effectiveness of sacroplasty in treating sacral insufficiency fractures. Pain improvement according to the numeric rating scale (NRS) showed a significant reduction from a mean of 7.8 (standard deviation [SD], 2.4) at baseline to 0.9 (SD, 2.2; p<.001) with 92% showing a clinically meaningful reduction in pain at 6 months follow-up. Rolland-Morris Disability Questionnaire (RMDQ) scores also significantly decreased from baseline levels from a mean of 17.7 (SD 6.4) to 5.2 (SD, 5.2; p<.001) at 6 months follow-up, with 84% achieving a clinically meaningful reduction. One patient had a new neurologic deficit due to cement extravasation, but no other adverse events were reported. A major limitation of this study is an imbalance in baseline characteristic and at the time of publication only 48% of patients have 6-month follow-up data.
Sarigul et al retrospectively described a single-center's experience with treating sacral insufficiency fractures with sacroplasty (n=83) or conservative treatment (n=102) (Sarigul, 2024). Participants had a mean age of 69.2 years and required 5 years of follow-up to be included in the study (mean follow-up time was 7.2 years). At baseline, both VAS (8.82 vs. 4.18) and ODI (68.6 vs. 51.8) were significantly higher in the sacroplasty group than those conservatively treated. By 1 year follow-up, mean VAS scores had significantly decreased in the sarcoplasty group to 1.5 and was favored over conservative treatment, which had a reduction to 2.82 (p<.001); a similar trend was observed for ODI, which showed a decrease to 8.4 in the sarcoplasty group compared to 21.2 in the conservative treatment group (p<.001). Cement leaks were identified in 2 patients, but no postoperative radiculopathy or pulmonary embolism were reported. Despite requiring 5-year data for all participants, only 1-year outcomes were reported by the authors.
There are several retrospective reviews with roughly 50 patients per publication. One reported by Dougherty et al described a series of 57 patients treated with sacroplasty for sacral insufficiency fractures (Dougherty, 2014). The short- or the long-axis approach was dictated by the length and type of the fracture and patient anatomy. Follow-up data at 2.5 weeks were available for 45 (79%) patients, and the outcome measures were inconsistent. For example, activity pain scores were collected from 13 patients, and rest pain scores were collected from 29 patients. Of the 45 patients with outcomes data, 37 (82%) had experienced a numeric or descriptive decrease from initial pain of at least 30%.
Adverse Events
There are complications related to cement leakage with sacroplasty that are not observed with vertebroplasty. Leakage of polymethylmethacrylate into the presacral space, spinal canal, sacral foramen, or sacroiliac joint may result in pelvic injection of polymethylmethacrylate, sacral nerve root or sacral spinal canal compromise, or sacroiliac joint dysfunction (Zaman, 2006). Performing sacroplasty only on zone 1 fractures can minimize these risks (Denis, 1988).
Kyphoplasty or Mechanical Vertebral Augmentation for Osteoporotic Vertebral Compression Fractures
Review of Evidence
The Agency for Healthcare Research and Quality (AHRQ) published a comparative effectiveness review on selected interventional treatments for acute and chronic pain in September 2021 (Chou, 2021). The review included 37 RCTs for 10 interventional procedures and conditions that evaluated pain, function, health status, quality of life, medication use, and harm. Results of the review concluded that vertebroplasty (13 trials) was probably more effective at reducing pain and improving function in patients over 65 years of age, but benefits were small (less than 1 point on a 10 point pain scale). Benefits of vertebroplasty appeared smaller in sham-controlled trials compared with trials involving usual care as a control and larger in trials involving patients with more acute symptoms. Vertebroplasty was also found to be probably not associated with an increased risk of incident vertebral fracture. Kyphoplasty (2 trials) was concluded to probably be more effective than usual care for pain and function in older patients with vertebral compression fracture at up to 1 month and may be more effective at greater than 1 month to 1 year or more but has not been compared against sham therapy. The evidence regarding the risk of incident fracture with kyphoplasty was conflicting. The overall evidence base for vertebroplasty had several limitations including variations in patient selection criteria, technical factors such as volume of polymethyl methacrylate, and sham interventions. Usual care interventions were also not well standardized or defined, and the majority of results were based on mean differences in outcomes. Few trials reported the likelihood of achieving a clinically relevant response and data on long-term outcomes were limited. For kyphoplasty, a major limitation is the absence of sham-controlled trials.
Kyphoplasty or Vertebroplasty versus Conservative Treatment
Meta-analyses
In a Bayesian network meta-analysis, Zhao et al examined the efficacy and safety of vertebroplasty, kyphoplasty, and conservative treatment for the treatment of osteoporotic vertebral compression fracture (Zhao, 2017). Sixteen RCTs were identified (N=2046 participants: vertebroplasty, n=816; kyphoplasty, n=478; conservative treatment, n=752). Eleven of the RCTs compared vertebroplasty with conservative treatment; 2 RCTs compared kyphoplasty with conservative treatment, and 3 RCTs compared kyphoplasty with vertebroplasty. Each trial assessed at least 1 of the following: VAS, the RMDQ, the European Quality of Life-5 Dimensions, and the observance of any new fractures. No significant difference was found between kyphoplasty and vertebroplasty for pain relief, daily function, and quality of life. Network meta-analysis demonstrated that kyphoplasty was superior to conservative therapy as assessed by VAS (mean difference, 0.94; 95% confidence interval [CI], -0.40 to 2.39), European Quality of Life-5 Dimensions (mean difference -0.10; 95% CI, -0.17 to -0.01), and RMDQ (mean difference, 5.72; 95% CI, 1.05 to 10.60). Insufficient data were present to complete pairwise comparison of kyphoplasty with conservative treatment for some metrics. Kyphoplasty was associated with the lowest risk of new fractures. This review was limited by significant heterogeneity across measured outcomes and length of follow-up in studies; the presence of performing and reporting bias in studies was also a concern.
Hinde et al performed a meta-analysis of 7 studies on the effect of vertebral augmentation (either vertebroplasty and/or balloon kyphoplasty) compared with nonsurgical management in over 1.5 million patients with osteoporotic vertebral compression fractures (Hinde, 2020). Compared with nonsurgical management, vertebral augmentation reduced risk of mortality (hazard ratio [HR], 0.78; 95% CI, 0.66 to 0.92). These benefits remained significant in stratified analyses of mortality over periods of 2 years (HR, 0.70; 95% CI, 0.69 to 0.71) and 5 years (HR, 0.79; 95% CI, 0.62 to 1.00). Most studies were rated with scores of 7 to 9 on the Newcastle-Ottawa rating scale.
Sun et al performed a meta-analysis of 32 studies (N=945) in patients with osteoporotic vertebral compression fracture treated with vertebral augmentation or conservative treatment (Sun, 2020). No significant differences were observed in the risk of clinical fracture (RR, 1.22; 95% CI, 0.70 to 2.12) or radiological fracture (RR, 0.91; 95% CI, 0.71 to 2.12). Overall, 10 studies were rated as high quality, and the remainder were rated as low quality. Results remained consistent when stratified by RCTs and non-RCTs.
Halvachizadeh et al conducted a systematic review and meta-analysis comparing vertebroplasty, kyphoplasty, and nonoperative management in patients with osteoporotic vertebral compression fractures (Halvachizadeh, 2021). A total of 16 RCTs (N=2731 patients) were included with 11 trials comparing vertebroplasty to nonoperative management, 1 trial comparing kyphoplasty to nonoperative management, and 4 comparing kyphoplasty and vertebroplasty. Surgical intervention was associated with greater improvement of pain as compared to nonoperative management and was unrelated to the development of adjacent level fractures or quality of life. Of the trials comparing kyphoplasty and vertebroplasty, no significant differences in outcome measures were observed. Fourteen of the 16 trials provided some concern for bias, and the remaining 2 trials provided a high concern for bias. The authors noted the heterogeneity of the included studies as a limitation. Nonoperative management was not standardized and the majority of studies failed to provide evidence of osteoporosis despite indicating that the treated fractures were osteoporotic vertebral fractures.
A network meta-analysis of RCTs conducted by Liu et al assessed the safety and efficacy of 12 interventions, including kyphoplasty, compared to conventional and sham treatments for osteoporotic vertebral compression fractures (Liu, 2023). The analysis included 34 RCTs, encompassing 4383 participants with an average age of 73.4 years. Each study required a control group and reported on outcomes measured by the VAS pain scale or the ODI. The authors included several subgroups of kyphoplasty (kyphoplasty with facet joint injection and curved kyphoplasty), which are not discussed further here. Improvements compared to conservative treatment were observed in both short-term and long-term VAS and ODI scores. Compared to sham treatment, no significant difference was noted in short-term VAS scores. However, a notable improvement favoring the kyphoplasty group was observed in long-term VAS outcomes, as well as in both short-term and long-term ODI outcomes. No significant differences were observed in the relative risk of new fractures between kyphoplasty and the sham or conservative control groups. Limitations consisted of differences in indications and follow-up times, significant heterogeneity across study findings, and more than 50% of included studies having been assessed with a moderate or high risk of bias.
Observational Studies
Edidin et al reported on mortality risk in Medicare patients who had osteoporotic vertebral compression fractures and had been treated with vertebroplasty, kyphoplasty, or nonoperatively (Edidin, 2011). Using the U.S. Medicare dataset, the authors identified 858,978 patients who had vertebral compression fractures between 2005 and 2008. The dataset included 119,253 kyphoplasty patients and 63,693 vertebroplasty patients. Survival was calculated from the index diagnosis date until death or the end of follow-up (up to 4 years). Cox regression analysis was used to evaluate the joint effect of multiple covariates, which included sex, age, race/ethnicity, patient health status, type of diagnosed fracture, site of service, physician specialty, socioeconomic status, year of diagnosis, and census region. After adjusting for covariates, patients in the surgical cohorts (vertebroplasty or kyphoplasty) had a higher adjusted survival rate (60.8%) than patients in the nonsurgical cohort (50.0%) and were 37% less likely to die. The adjusted survival rates for vertebroplasty or kyphoplasty were 57.3% and 62.8%, respectively, a 23% lower relative risk for kyphoplasty. As noted by the authors, a causal relationship could not be determined from this study.
An industry-sponsored analysis by Ong et al evaluated the effect of the sham-controlled vertebroplasty trials on utilization of kyphoplasty/vertebroplasty, morbidity, and mortality in the Medicare population (Ong, 2018; Kallmes, 2009; Buchbinder, 2009). Using the complete inpatient/outpatient U.S. Medicare data set from 2005 to 2014, the investigators evaluated utilization of vertebral augmentation procedures in patients with osteoporotic vertebral compression fractures who were treated in the 5 year period before 2009 and those who were treated in the 5 years after the sham-controlled trials were published. Use of the 2 procedures peaked at 24% of the osteoporotic vertebral compression fracture population in 2007 to 2008, then declined to 14% of osteoporotic vertebral compression fracture patients in 2014. Compared to patients with osteoporotic vertebral compression fractures treated non-surgically, the kyphoplasty cohort (n=261,756) had a 19% (95% CI, 19 to 19) lower propensity-adjusted 10-year mortality risk. Compared to patients with osteoporotic vertebral compression fracture treated with vertebroplasty (n=117,232), the kyphoplasty cohort had a 13% (95% CI, 12 to 13) lower propensity-adjusted 10-year mortality risk. The study also found that patients treated with non-surgical management were more likely to be discharged to nursing facilities. Although the analysis did adjust for possible confounding factors, the observational nature of the study precludes any inference of causality.
Balloon Kyphoplasty Versus Conservative Care
The largest trial of kyphoplasty versus conservative care is by Wardlaw et al, who reported the Fracture Reduction Evaluation (FREE) trial, a nonblinded, industry-sponsored, multisite RCT involving 300 adults with 1 to 3 painful osteoporotic vertebral compression fractures of less than 3 months in duration (Wardlaw, 2009). Twenty-four-month results were reported by Boonen et al and by Van Meirhaeghe et al (Boonen, 2011; Van Meirhaeghe, 2013). Scores for the primary outcome, 1-month change in the 36-Item Short-Form Health Survey Physical Component Summary score, were significantly higher for those in the kyphoplasty group. The difference between groups was 5.2 points (95% CI, 2.9 to 7.4 ; p<.001). Kyphoplasty was associated with greater improvements in the 36-Item Short-Form Health Survey Physical Component Summary scores at 6-month follow-up (3.39 points), but not at 12- or 24-month follow-ups. Greater improvement in back pain was observed over 24 months for kyphoplasty (-1.49 points) and remained statistically significant at 24 months. Participants in the kyphoplasty group also reported greater improvements in quality of life and RMDQ scores at short-term follow-up. At 12 months, fewer kyphoplasty patients (26.4% vs. 42.1%) had received physical therapy or walking aids, back braces, wheelchairs, miscellaneous aids, or other therapy. Fewer kyphoplasty patients used opioid medications through 6 months (29.8% vs. 42.9%) and fewer pain medications through 12 months (51.7% vs. 68.3%). Other differences between groups were no longer apparent at 12 months, possibly due to natural healing of fractures.
Mechanical Vertebral Augmentation (eg, Kiva or SpineJack) versus Balloon Kyphoplasty
Vertebral augmentation with the Kiva vertebral compression fractures system was compared with balloon kyphoplasty in a pivotal noninferiority RCT reported by Tutton et al (Tutton, 2015). This industry-sponsored, multicenter, open-label, Kiva safety and effectiveness trial was conducted in 300 patients with 1 or 2 osteoporotic vertebral compression fractures. Included were patients with VAS scores for back pain of at least 70 mm (/100 mm) after 2 to 6 weeks of conservative care or VAS scores of at least 50 mm after 6 weeks of conservative care, and ODI scores of at least 30%. The primary composite endpoint at 12 months was a reduction in fracture pain by at least 15 mm on the VAS, maintenance or improvement in function on the ODI, and absence of device-related serious adverse events. The primary endpoint was met by 94.5% of patients treated with Kiva and 97.6% of patients treated with kyphoplasty (Bayesian posterior probability of 99.92% for noninferiority, using as-treated analysis). In the 285 treated patients, Kiva resulted in a mean improvement of 70.8 points in VAS scores, compared with a 71.8 point improvement for kyphoplasty. There was a 38.1 point improvement in ODI score for the Kiva group compared with a 42.2 point improvement for the kyphoplasty group. There were no device-related serious adverse events. The total volume of cement was 50% less with Kiva, and there was less cement extravasation (16.9%) compared with kyphoplasty (25.8%).
Korovessis et al reported on a randomized trial of 180 patients with osteoporotic vertebral compression fractures that compared mechanical vertebral augmentation with the Kiva device with balloon kyphoplasty in 180 patients with osteoporotic vertebral compression fractures (Korovessis, 2013). The groups showed similar improvements in VAS scores for back pain, 36-Item Short-Form Health Survey scores, and ODI scores. For example, there was a more than 5.5 point improvement in VAS scores in 54% of patients in the Kiva group and 43% of patients in the balloon kyphoplasty group. Radiologic measures of vertebral height were similar in both groups. Kiva reduced the Gardner kyphotic angle, while residual kyphosis of more than 5 was more frequently observed in the balloon kyphoplasty group. Patients and outcome assessors were reported to be unaware of group assignments, although it is not clear if the Kiva device was visible on radiographs. Cement leakage into the canal only occurred in 2 patients treated with balloon kyphoplasty, necessitating decompression, compared with none following the Kiva procedure.
Noriega et al reported the pivotal multicenter non-inferiority trial of the SpineJack vertebral augmentation system (Noriega, 2019). Patients (N=152) with osteoporotic vertebral compression fractures less than 3 months old were randomized to treatment with SpineJack or balloon kyphoplasty. The primary outcome was a composite measure that included improvement in VAS for pain of greater than 20 mm, maintenance or improvement in ODI, and lack of adverse events. Vertebral height was prespecified to be included if the primary outcome was achieved. Non-inferiority was achieved with 89.8% of SpineJack patients achieving the composite of clinical success compared to 87.3% for balloon kyphoplasty. When including the restoration of vertebral body height, the SpineJack procedure was found to be superior to balloon kyphoplasty at 6 months (88.1% vs. 60.9%) and 12 months (79.7% vs. 59.3%, p<.001). There was also a reduction in adjacent vertebral fractures with the mechanical augmentation system (12.9% vs. 27.3%; p=.043). Interpretation of this study is limited by the lack of a sham control group.
Osteolytic Vertebral Compression Fractures
Review of Evidence
Systematic Reviews
In a systematic review, Health Quality Ontario assessed vertebral augmentation for cancer-related vertebral compression fractures (Pron, 2016). The assessment identified 33 reports with 1690 patients who were treated with kyphoplasty for spinal metastatic cancers, multiple myeloma, or hemangiomas. For cancer-related vertebral compression fractures, there were 5 case series (110 patients) on multiple myeloma and 6 reports (2 RCTs, 4 case series; 308 patients) on mixed cancers with spinal metastases. Vertebral augmentation resulted in reductions in pain intensity scores, opioid or other analgesic use, and disability scores. One RCT (N=129) compared kyphoplasty with nonsurgical management for cancer-related vertebral compression fractures, reporting that pain scores, pain-related disability, and health-related quality of life were significantly improved in the kyphoplasty group than in the usual care group. The second RCT compared the Kiva device with kyphoplasty in 47 patients with cancer-related compression fractures, finding no significant differences between groups for improvements in VAS pain and ODI scores.
Mattie et al conducted a systematic review and meta-analysis of 7 RCTs (N=476) that compared the magnitude and duration of pain relief with vertebral augmentation (i.e., balloon kyphoplasty or percutaneous vertebroplasty), with or without additional therapy, to any other intervention or placebo/sham for the treatment of cancer-related vertebral compression fractures (Mattie, 2021). In 5 of the 7 studies, vertebral augmentation alone comprised 1 group; comparative treatments included nonsurgical management, Kiva implantation, and combinations of percutaneous vertebroplasty and radiofrequency therapy, chemotherapy, instrasomatic steroid injection, or 125I seeds. Results revealed an overall positive and statistically significant effect of vertebral augmentation for the management of cancer-related vertebral compression fractures. This effect was particularly pronounced when comparing vertebral augmentation to nonsurgical management, radiofrequency ablation, or chemotherapy alone. The authors noted that there was much heterogeneity among the included studies regarding the treatment methods in the control groups, and 1 study allowed patients to crossover to the intervention group, potentially leading to biased results.
Randomized Controlled Trials
The only RCT to compare kyphoplasty to non-surgical management was an international multicenter study reported by Berenson et al (Berenson, 2011). The trial enrolled 134 patients with cancer who had at least 1 and not more than 3 painful osteolytic vertebral compression fractures. The primary outcome was change in functional status from baseline at 1 month as measured by the RMDQ. Treatment allocation was not blinded, and the primary outcome at 1 month was analyzed using all participants with data both at baseline and at 1 month. Participants needed to have a pain score of at least 4, on a 0-to-10 scale. Crossover to the balloon kyphoplasty arm was allowed after 1 month. Reviewers reported scores for the kyphoplasty and nonsurgical groups of 17.6 and 18.2 at baseline, respectively, and 9.1 and 18.0 at 1-month follow-up (between-group difference in scores, p<.001).
Korovessis et al compared the efficacy of Kiva and kyphoplasty in an RCT with 47 participants with osteolytic vertebral compression fractures (Korovessis, 2014). Oswestry Disability Index scores improved by 42 and 43 points in the kyphoplasty and Kiva groups, respectively. Pain scores improved by 5.1 points in both groups, from baseline mean scores of 8.1 (kyphoplasty) and 8.3 (Kiva).
Radiofrequency Kyphoplasty
Review of Evidence
Meta-analysis
Feng et al performed a meta-analysis comparing radiofrequency kyphoplasty with balloon kyphoplasty in patients with vertebral compression fractures (Feng, 2017). Six studies (N=833 patients) evaluating vertebral compression fractures were identified. The main outcomes were pain relief (VAS), functionality improvement (ODI), operation time, reduction of deformity (i.e., the restoration of vertebral height and kyphosis angle), and incidence of cement leakage. Visual analogue scale score improved for both groups after the respective procedure; however, VAS score dropped 3.96 points more in the radiofrequency kyphoplasty group (95% CI, 1.67 to 6.24; p=.001), with improvement persisting until the 12-month mark. While functionality improvement was initially improved more after radiofrequency kyphoplasty than balloon kyphoplasty (p=.04), the difference between the 2 groups was not significant after a year (p=.6). No significant difference in cement leakage between groups was observed. This review was limited by the small number of studies included as well as the presence of significant bias within these studies.
Randomized Controlled Trials
Petersen et al reported on an RCT with 80 patients that compared radiofrequency kyphoplasty with balloon kyphoplasty (Petersen, 2016). Patients had been admitted to the hospital for severe back pain and met the criteria for surgery after failed conservative treatment. All had osteoporotic compression fractures. Before treatment, VAS pain scores on movement were similar in both groups (8.4 in the balloon kyphoplasty group vs. 8.0 in the radiofrequency kyphoplasty group). Postoperatively, VAS improved by 4.6 after balloon kyphoplasty and 4.4 after radiofrequency kyphoplasty (p=not significant). Pain at 12 months also did not differ significantly between both groups, with 58% of patients in the balloon kyphoplasty group and 66% of patients in the radiofrequency kyphoplasty group reporting no to mild pain on movement (p=not significant). There was a trend for greater restoration of the kyphosis angle.
Adverse Events
Yi et al assessed the occurrence of new vertebral compression fractures after treatment with cement augmenting procedures (vertebroplasty or kyphoplasty) versus conservative treatment in an RCT with 290 patients (363 affected vertebrae) (Yi, 2014). Surgically treated patients were discharged the next day. Patients treated conservatively (pain medication, bed rest, a body brace, physical therapy) had a mean length of stay of 13.7 days. Return to usual activity occurred at 1 week for 87.6% of surgically treated patients and 2 months for 59.2% of conservatively treated patients. All patients were evaluated with radiographs and magnetic resonance imaging at 6 months and then at yearly intervals until the last follow-up session. At a mean follow-up of 49.4 months (range, 36 to 80), 10.7% of patients had experienced 42 new symptomatic vertebral compression fractures. There was no significant difference in the incidence of new vertebral fractures between the operative (n=18; 9 adjacent, 9 nonadjacent) and conservative (n=24; 5 adjacent, 16 nonadjacent, 3 same level) groups, but the mean time to a new fracture was significantly shorter in the surgical group (9.7 months) compared with the nonoperative group (22.4 months).
Supplemental Information
American College of Radiology
The American College of Radiology and 7 other surgical and radiologic specialty associations published a joint position statement on percutaneous vertebral augmentation (Baerlocher, 2014). This document stated that percutaneous vertebral augmentation, using vertebroplasty or kyphoplasty and performed in a manner consistent with public standards, is a safe, efficacious, and durable procedure in appropriate patients with symptomatic osteoporotic and neoplastic fractures. The statement also indicated that these procedures be offered only when nonoperative medical therapy has not provided adequate pain relief, or pain is significantly altering the patient's quality of life.
A joint practice parameter for the performance of vertebral augmentation was updated in 2017 (ACR, 2014).
In 2022, the American College of Radiology (ACR) revised its Appropriateness Criteria for the use of percutaneous vertebral augmentation in the management of vertebral compression fractures (ACR, 2024). Below shows the appropriateness categories for each variant.
ACR Appropriateness Criteria for the Use of Percutaneous Vertebral Augmentation for the Management of Vertebral Compression Fractures:
Society of Interventional Radiology
In a 2014 quality improvement guideline for percutaneous vertebroplasty from the Society of Interventional Radiology, failure of medical therapy was defined as follows (Baerlocher, 2014):
American Academy of Orthopaedic Surgeons
In 2011, the American Academy of Orthopaedic Surgeons (AAOS) published practice guidelines on the treatment of osteoporotic spinal compression fractures (McGuire, 2011). The AAOS approved "a strong recommendation against the use of vertebroplasty for patients who present with an acute osteoporotic spinal compression fracture and are neurologically intact."
National Institute for Health and Care Excellence
In 2003, NICE concluded in its guidance on percutaneous vertebroplasty that the current evidence on the safety and efficacy of vertebroplasty for vertebral compression fractures appeared "adequate to support the use of this procedure" to "provide pain relief for people with severe painful osteoporosis with loss of height and/or compression fractures of the vertebral body…." The guidance also recommended that the procedure be limited to patients whose pain is refractory to more conservative treatment. A 2013 NICE guidance, which was reaffirmed in 2016, indicated that percutaneous vertebroplasty and percutaneous balloon kyphoplasty "are recommended as options for treating osteoporotic vertebral compression fractures" in persons having "severe, ongoing pain after a recent, unhealed vertebral fracture despite optimal pain management" and whose "pain has been confirmed to be at the level of the fracture by physical examination and imaging." In 2008, NICE issued guidance on the diagnosis and management of adults with metastatic spinal cord compression (NICE, 2008). This guidance indicated that vertebroplasty or kyphoplasty should be considered for "patients who have vertebral metastases and no evidence of metastatic spinal cord compression or spinal instability if they have: mechanical pain resistant to conventional pain management, or vertebral body collapse." It was last reviewed in 2019, and a decision was made that the guideline required updating as "since its publication, there have been advances in the diagnosis and management of metastatic spinal cord compression " (NICE, 2013). The guidance currently still states that vertebroplasty or kyphoplasty should be considered for patients who have vertebral metastases, and no evidence of spinal cord compression or spinal instability, if they have mechanical pain resistant to conventional pain management and vertebral body collapse. Surgery should only be performed when all appropriate specialists agree. Despite a relatively small sample base, the Institute concluded the evidence suggests, in a select subset of patients, that early surgery may be more effective at maintaining mobility than radiotherapy.
The NICE issued a guidance that recommended percutaneous vertebroplasty and percutaneous balloon kyphoplasty as treatment options for osteoporotic vertebral compression fractures in persons having severe, ongoing pain after a recent unhealed vertebral fracture, despite optimal pain management, and whose pain has been confirmed through physical exam and imaging at the level of the fracture (NICE, 2013). This guidance did not address balloon kyphoplasty with stenting, because the manufacturer of the stenting system (Synthes) stated there is limited evidence for vertebral body stenting given that the system had only recently become available.
American Society of Pain and Neuroscience
In 2021, the American Society of Pain and Neuroscience (ASPN) published practice guidelines for the interventional management of cancer-associated pain (Aman, 2021). The guideline included a best practice statement that stated "vertebral augmentation should be strongly considered for patients with symptomatic vertebral compression fractures from spinal metastases (evidence level 1-A)." However, ASPN noted that there is little data to suggest the superiority of either vertebroplasty or kyphoplasty when treating malignant vertebral compression fractures.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are below.
Summary of Key Trials:
Ongoing
Unpublished
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Aman MM, Mahmoud A, Deer T, et al.(2021) The American Society of Pain and Neuroscience (ASPN) Best Practices andGuidelines for the Interventional Management of Cancer-Associated Pain. J Pain Res. 2021; 14: 2139-2164. PMID34295184 American College of Radiology (ACR).(2022) Management of vertebral compression fractures. https://acsearch.acr.org/docs/70545/Narrative/. Published 2022. Accessed March 7, 2023. Bae H, Hatten HP, Linovitz R, et al.(2012) A prospective randomized FDA-IDE trial comparing Cortoss with PMMA for vertebroplasty: a comparative effectiveness research study with 24-month follow-up. Spine (Phila Pa 1976). Apr 01 2012; 37(7): 544-50. PMID 21738093 Chang M, Zhang C, Shi J, et al.(2021) Comparison Between 7 Osteoporotic Vertebral Compression Fractures Treatments: Systematic Review and Network Meta-analysis. World Neurosurg. Jan 2021; 145: 462-470.e1. PMID 32891841 Hinde K, Maingard J, Hirsch JA, et al.(2020) Mortality Outcomes of Vertebral Augmentation (Vertebroplasty and/or Balloon Kyphoplasty) for Osteoporotic Vertebral Compression Fractures: A Systematic Review and Meta-Analysis. Radiology. Apr 2020; 295(1): 96-103. PMID 32068503 Zhang L, Zhai P.(2020) A Comparison of Percutaneous Vertebroplasty Versus Conservative Treatment in Terms of Treatment Effect for Osteoporotic Vertebral Compression Fractures: A Meta-Analysis. Surg Innov. Feb 2020; 27(1): 19-25. PMID 31423902 |
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