Percutaneous vertebroplasty is considered investigational for all other indications, including use in acute vertebral fractures due to osteoporosis or trauma.
Percutaneous sacroplasty is considered investigational for all indications, including use in sacral insufficiency fractures due to osteoporosis and spinal lesions due to metastatic malignancies or multiple myeloma.
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In 2001, the following CPT codes were introduced to specifically describe percutaneous vertebroplasty of thoracic or lumbar vertebrae:
- 22520 - 22521
- 72291 - 72292
Prior to 2001, the following nonspecific CPT codes may have been used to describe individual components of the procedure:
There are CPT category III codes for sacroplasty:
This policy was originally based on a 2000 TEC Assessment (9) and updated with TEC Assessments in 2004,2005, 2008, 2009, and 2010. (10-14) Originally, the available data were observational. Evidence from observational studies were generally consistent in showing significant decreases in pain from an initial preoperative level of 8 to 9 on a visual analog scale (VAS, or similar score proportionate to the highest possible score) to 2 to 4, typically within 1 day of receiving the procedure. Such pain relief appears to be lasting in the limited studies that reported long-term outcomes. In terms of adverse outcomes, leakage of the cement outside of the vertebral body is a common occurrence, occurring in between 19% and 72% in 8 studies that reported its occurrence. The largest of the case series reported results from a prospectively collected database with 552 patients from a large academic department. (15) The database consisted of baseline and postoperative measures, with follow-up by telephone at 1 week and 1, 6, 12, and 24 months (89%, 84%, 75%, 67%, and 62% patients at follow-up, respectively). The average age of the patients was 74 years (range: 28-96 years). Eighty-four percent of the procedures were performed for compression fractures related to osteoporosis, with an average duration of symptoms before treatment of 3.6 months. New compression fractures were observed following 23% (156) of the procedures; of these, 106 (68%) underwent an additional vertebroplasty procedure. Vertebroplasty was reported to decrease pain levels at rest and during activity by 50% or more (VAS of 4.5 to 1.7, and 8.4 to 3.6, respectively) beginning 2 hours after surgery; 87% of patients reported a decrease in pain. The Roland-Morris disability score improved from 18.4 at baseline to 10.8 at 1-week follow-up and remained near this level throughout follow-up. Medication use was reported to decrease in more than 66% of patients. Beginning in 2007, data from randomized clinical trials (RCTs) began appearing in the literature. This policy is now focused on RCT data.
Outcomes of Treatment
For treatment of osteoporosis and malignancy with percutaneous vertebroplasty (PVP) or sacroplasty, the primary beneficial outcomes of interest are relief of pain and improvement in ability to function. Ex vivo cadaver studies reporting bone strength as a surrogate outcome measure have been reported but are not included in this evaluation of health outcomes. In treatment of aggressive hemangioma, the primary benefits of PVP include relief of pain and reduction of blood loss associated with surgical treatment.
Pain and functional ability are subjective outcomes and, thus, may be susceptible to placebo effects. Furthermore, the natural history of pain and disability associated with these conditions may be variable. Therefore, controlled comparison studies would be valuable to demonstrate the clinical effectiveness of PVP and sacroplasty over and above any associated nonspecific or placebo effects and to demonstrate the effect of treatment compared to alternatives such as continued medical management.
In all clinical situations, adverse effects related to complications from PVP and sacroplasty are the primary harms to be considered. Principal safety concerns relate to the incidence and consequences of leakage of the injected PMMA.
The VERTOS 1 study was a small randomized clinical trial of 34 patients. (16) Patients had been refractory to medical management for at least 6 weeks and no longer than 6 months. The authors noted that many patients had been referred for vertebroplasty following failed conservative treatment and did not want to be randomized to the optimized medication control group or chose to crossover to vertebroplasty after only 2 weeks of conservative treatment. Thus, the follow-up in the study was very short. Vertebroplasty was found to decrease analgesic use (1.9 to 1.2 vs. 1.7 to 2.6 in the optimized medication group) and resulted in a 19% improvement in the Roland-Morris Disability Questionnaire (RMDQ) (vs. -2% in controls) 2 weeks following the procedure. Excluding 2 patients (11%) who had adjacent vertebral compression fractures by the 2-week follow-up, mean VAS scores for pain decreased from 7.1 to 4.4 (vs. 7.6 to 6.4 for controls). Patients who crossed over from conservative management to vertebroplasty had improvements after the procedure.
In 2009, two randomized trials compared vertebroplasty to a sham procedure (that included local anesthetic) that mimicked the vertebroplasty procedure up to the point of cement injection. (17,18) Buchbinder and colleagues reported results of a four-center, randomized, double-blind, sham-controlled trial in which 78 participants with 1 or 2 painful osteoporotic vertebral fractures of duration less than 1 year were assigned to undergo vertebroplasty or sham procedure (i.e., injection of local anesthetic into the facet capsule and/or periosteum). (17) Ninety-one percent of participants completed 6-month follow-up. This study was designed to determine short-term efficacy and safety of vertebroplasty for alleviating pain and improving physical functioning in persons with painful osteoporotic vertebral fractures. The participants, investigators (other than the radiologists performing the procedure), and outcome assessors were blind to the treatment assignment.
Recruitment took place within the practices of both general practitioners and specialists from hospital inpatient and emergency departments. In general, participants were required to have back pain of no more than 12 months and the presence of at least 1 but no more than 2 recent vertebral fractures. Participants were evaluated at baseline, then with a mailed questionnaire at 1 week and 1, 3, and 6 months after the procedure. The primary outcome was overall pain (over the course of the previous week) measured on a 0 to 10 VAS, with 1.5 representing the minimal clinically important difference. A sample size of 24 per group was calculated to provide 80% power with 2-sided α 0.05 to show a 2.5-point post-procedure difference assuming a 3-point standard deviation (SD). All analyses were performed according to intention-to-treat principles. Results are presented as difference from baseline. For the primary outcome of overall pain, the authors report no significant difference in VAS pain score at 3 months.
The major methodologic strength of the trial was employing a sham procedure to control for nonspecific (placebo) effects, which has been reported to be quite large for invasive procedures, on the order of 6 to 7 mm on a 100-mm scale. (19-22) However, the sham used in the trial is not without controversy, as it might be considered an active control—the effect of injecting local anesthetic in the facet capsule and/or periosteum is unknown. Without a clear understanding of the short- and long-term effects of the injection on pain, questions will remain. With reductions in pain and improvements in quality of life observed in both groups, the authors concluded vertebroplasty provided no benefit.
There was considerable variability in pain scores, which may in part be due to a lack of minimum pain score at entry. The primary outcome measure was the mean difference in VAS from baseline. For some continuous outcomes, pain being one, there is a magnitude of improvement that is clinically meaningful on an individual level; someone achieving that minimal change can be considered a responder. Under these circumstances, a fundamental limitation of continuous effect measures is failing to identify the proportion of patients experiencing a meaningful clinical response. (23) Since a clinically meaningful important improvement has been established, the proportion of patients responding is the most informative outcome. (24) Moreover, when considered in this manner, response or meaningful improvement (2.5 on the VAS) in overall pain at 1, 3, and 6 months was more frequent with vertebroplasty—respective relative risks (RRs) of 1.2 (95% confidence interval [CI]: 0.7 to 2.0), 1.5 (95% CI: 0.9 to 2.6), and 1.3 (95% CI: 0.8 to 2.1). However, detecting an increase in response from 40% (sham) to 60% with 80% power would have required a sample exceeding 200 participants. Also, at entry, many participants had experienced pain longer than 3 months; (25) suggesting that the VAS may not be as responsive as other measures for these patients. (25) This adds to the uncertainty as to whether a mean change in VAS will capture clinically meaningful improvement.
Kallmes et al. also conducted a multicenter, randomized, double-blind, sham-controlled trial in which 131 participants with 1 to 3 painful osteoporotic vertebral fractures of duration less than 1 year were assigned to undergo vertebroplasty or sham procedure (injection of local anesthetic into the facet capsule and/or periosteum). (18) Ninety-seven percent completed a 1-month follow-up, and 95% completed 3 months. Participants were enrolled from five centers each in the U.S. and the U.K., and one in Australia. Sites were selected based on experience performing vertebroplasty for osteoporotic fractures. The trial was designed to determine the efficacy of vertebroplasty patients with painful osteoporotic compression fractures, as compared to a simulated procedure. Both participants and outcome assessors were blinded to the treatment assignment. 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 baseline, then again at various time points to 1-year post-procedure. The primary outcomes were scores on the RMDQ and average back pain intensity during the preceding 24 hours at 1 month. A reduction of 30% on the RMDQ and VAS pain was considered a clinically meaningful difference. (26)
The study initially had 80% power to detect differences in both primary and secondary outcomes with 250 patients, with a 2-sided alpha of 0.05 on the basis of a 2.5-unit advantage for vertebroplasty over placebo on the RMDQ and 1.0 point difference on VAS. After recruitment difficulty and interim analysis on first 90 participants, target sample size was decreased to 130 participants with 80% power for primary aims maintained. All primary analyses were performed according to intention-to-treat principles and results presented as mean score for the RMDQ and pain intensity.
Like the Buchbinder et al. trial, (17) this trial employed an elaborate sham procedure (injection of local anesthetic). 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=0.06). At 3 months, 43% from the control group vs. 12% in the vertebroplasty group crossed over (p<0.001). The crossovers did not affect study outcomes, as they occurred after the primary outcome assessment. However, significantly more participants in the control group chose to cross over than in the vertebroplasty group.
As in the Buchbinder et al. trial, Kallmes et al. employed the same sham procedure, which is both a major strength and a potential threat to the validity of their conclusions due to the unknown effect of the sham on short- and long-term self-reported pain. Response or a clinically meaningful improvement was also not the primary outcome. With the decrease in sample size due to recruitment issues, the study was left underpowered for its secondary aims. This leaves uncertainty around the interpretation of lack of statistical significance of the difference in proportions of patients responding to treatment with a clinically meaningful improvement in pain.
The 2 randomized, sham-controlled trials concluded that vertebroplasty showed no benefit above sham for painful osteoporotic fractures. However some uncertainty remains around the interpretation of their conclusions. Both trials were underpowered to observe and compare the proportion of participants experiencing a clinically meaningful difference in pain, which is the most informative outcome measure. Furthermore, the responder outcome measures in both trials showed differences in the clinically meaningful difference in pain albeit not statistically significant.
Due to questions in methodology, including but not limited to the choice of sham procedure, the potential effect of the sham procedure on outcomes and the appropriateness of chosen outcome measures to detect clinically meaningful differences in pain, uncertainty remains regarding potential efficacy of vertebroplasty based on these studies. The 2009 TEC Assessment concluded that the scientific evidence did not permit conclusions concerning the effects of vertebroplasty on net health outcome for osteoporotic vertebral fractures. (12)
Following the 2009 TEC Assessment, two randomized trials were published. Rousing et al. (27) reported on a nonblinded randomized trial in which participants were randomized to either vertebroplasty or conservative management. These participants had no conservative therapy prior to enrolling in the trial. The study enrolled 40 participants with acute fractures and 10 with subacute (2–8 weeks). While immediate pain relief was observed in the vertebroplasty group, reductions in pain from baseline to 3-month follow-up were similar in the two groups. The authors concluded that conservative management should be used in the acute phase. The primary limitations of this study include its small size and incomplete pain assessment at the baseline visit.
Klazen et al. (28) conducted an open-label prospective randomized trial, of 202 patients, at 6 hospitals in the Netherlands and Belgium. Participants with at least one painful osteoporotic vertebral fracture of duration of 6 weeks or less were assigned to undergo vertebroplasty or conservative management (i.e., bed rest, analgesia, and cast and physical support). Ninety-three participants received vertebroplasty while 95 received conservative management; 81% of participants completed 1-year follow-up. The trial was designed to assess the efficacy of vertebroplasty compared to conservative management for the treatment of osteoporotic vertebral compression fractures. There was no blinding of participants, investigators, or outcome assessors to treatment assignment, due to the lack of a sham procedure.
Participants were recruited after referral from their primary care provider for spine radiography because of back pain. In general, participants were required to be at least 50 years of age or older, have compression fracture with height loss of the vertebral body of at least 15% on x-ray of the spine, the level of fracture was Th5 or lower back with pain of a duration of 6 weeks or less with a severity of at least 5 on the VAS. Participants were clinically evaluated at baseline, 1 day, 1 week, 1 month, 3 months, 6 months and 12 months after treatment. Primary outcome was pain relief at 1 month and 12 months measured on a 10-point VAS scale. A sample size of 100 per group was calculated to provide 80% power with an alpha of 0.05 to show a 25% difference in pain relief. All analyses were performed according to intention-to-treat principles. Clinically significant pain relief was defined as 30% change on the VAS (0-10 scale).
One hundred and one participants were enrolled into the treatment group and 101 into the control arm; 81% completed 12 months’ follow-up. Except for the primary outcome, difference in mean pain score from baseline, at 3 months, and 12 months, vertebroplasty resulted in greater pain relief than did medical management at 1 month and 1 year; there were significant between group differences at 1 month (2.6; 1.74 to 3.37, p<0.0001) and at 1 year (2.0; 1.13 to 2.80, p<0.0001). Survival analysis showed significant pain relief was quicker (29.7 vs. 115.6 days) and was achieved in more patients after vertebroplasty than after conservative management. There was cement leakage in 72% of patients after vertebroplasty with all patients remaining asymptomatic, and at a mean of 11.4 months’ follow-up, there was no significant difference in number of new fractures between groups, with 18 new fractures in 15 patients who had vertebroplasty compared to 30 new fractures in 21 participants undergoing medical management.
A methodologic strength of this study is the study’s focus on acute fracture, a subset of those with osteoporotic vertebral compression fractures, while other studies (Buchbinder et al. 2009 ; Kallmes et al. 2009 ) enrolled participants with pain out to 1 year. The inclusion of both chronic and acute fractures may mask the efficacy of the procedure in one subset. Klazen and colleagues also provided an a priori definition of clinically significant change in pain as one that registered a 30% difference on the 10-point VAS. (28) These data were incorporated as events in a survival analysis as part of the analysis of the primary outcome.
Although not randomized, there was one other comparative study specifically aimed at patients with acute fracture. Diamond et al. enrolled 79 consecutive patients with acute vertebral fractures. (29) All patients were offered vertebroplasty, and those who declined followed as a comparison group. The two groups had balanced baseline characteristics. At 24 hours, the group undergoing vertebroplasty (n=55) had much improved pain compared to the control group (n=24). However, at 6 weeks and between 6 and 12 months, there were no differences between groups in pain scores. The control group had an identical mean pain score to the vertebroplasty group at the end of follow-up. Similar findings were shown for the Barthel index of physical functioning. At long-term follow-up, there was still slightly higher functioning in the group undergoing vertebroplasty but no difference in the percent improvement from baseline between groups. The authors interpreted these findings as demonstrating that vertebroplasty produced faster resolution of symptoms than conservative management, as was shown in the Klazen trial.
Sacroplasty is an evolving technique with numerous methods (short axis, long axis, balloon-assisted short axis, and iliosacral screws). No randomized trials of sacroplasty have been reported. Published evidence is mostly from case reports (30-34) and small case series (all but one enrolling fewer than 13 patients). (35-44) No consensus for best practices has been published. The largest experience is a prospective observational cohort study of 52 consecutive patients undergoing sacroplasty for sacral insufficiency fractures using the short axis technique. (45) Patients had a mean age of 75.9 years and a mean duration of symptoms of 34.5 days (range: 4-89 days) and mean VAS score of 8.1 at baseline. Improvement on the VAS scale was measured at 30 minutes and 2, 4, 12, 24, and 52 weeks postprocedure. At each interval, statistically significant improvement over baseline was observed and maintained through 52 weeks. Additional literature reports are mostly consistent reporting immediate improvement following the procedure. Due to the small size of the evidence base, harms associated with sacroplasty have not been adequately studied. There are complications of cement leakage with sacroplasty that are not observed with vertebroplasty. Leakage of PMMA into the presacral space, spinal canal, sacral foramen, or sacroiliac joint may result in pelvic injection of PMMA, sacral nerve root or sacral spinal canal compromise, or sacroiliac joint dysfunction. (46) Performing sacroplasty on Zone 1 fractures only can minimize these risks. (47)
Physician Specialty Society and Academic Medical Center Input
In response to requests, input was received from 5 physician specialty societies and 2 academic medical centers while this policy was under review in 2008. Unsolicited input was received from a sixth physician specialty society. While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. All reviewers disagreed with the proposed policy and provided references in support of the use of vertebroplasty.
In 2008 after consideration of the uniform clinical input, it was concluded that although the scientific evidence does not permit conclusions about the impact on health outcomes and although comparative studies with long-term outcomes were lacking, numerous case series, including large prospective reports, consistently show that vertebroplasty may alleviate pain and improve function in patients with vertebral fractures who fail to respond to conservative treatment (at least 6 weeks with analgesics, physical therapy, and rest). Given the absence of alternative treatment options and the morbidity associated with extended bed rest, vertebroplasty may be considered a reasonable treatment option in patients with vertebral fractures who fail to improve after 6 weeks of conservative therapy. There are no additional data that would alter this conclusion.
After reviewing the literature, there is insufficient evidence to permit conclusions on the use of vertebroplasty for an acute fracture. The Klazen et al. trial (28) is a well-done study, whose results should be replicated and verified.
Sacroplasty is under development. Varying techniques, patient indications, and small numbers of treated patients leaves uncertainty regarding the impact of sacroplasty on health outcomes and does not permit conclusion on its use for sacral insufficiency fractures or other indication.
Practice Guidelines and Position Statements
In 2010, the American Academy of Orthopaedic Surgeons (AAOS) Board of Directors approved a new clinical practice guideline on the treatment of osteoporotic spinal compression fractures, which is available online at: http://www.aaos.org/Research/guidelines/SCFguideline.asp. The Board approved a strong recommendation against the use of vertebroplasty for patients who “present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically “intact.” In coming out with a strong recommendation, the committee expressed their confidence that future evidence is unlikely to overturn the existing evidence. As a note, these recommendations were based on a literature review through September 2009; therefore, the Klazen et al. trial was not included in the systematic review.
The updated 2009 TEC Assessment showed that data provide consistent, although not statistically significant, improvements in clinically meaningful differences in pain with vertebroplasty. With limited power for these outcomes, and the consistent but uncontrolled evidence from nonrandomized comparative studies and case series, there is uncertainty regarding potential efficacy of vertebroplasty based on these studies. The 2009 TEC Assessment concluded that the evidence for vertebroplasty did not meet TEC criteria because the scientific evidence did not permit conclusions concerning the effects of vertebroplasty on net health outcome for osteoporotic vertebral fractures. (12)
The United Kingdom’s National Institute for Health and Clinical Excellence (NICE) concluded in 2003 and 2006 that the current evidence on the safety and efficacy of balloon vertebroplasty for vertebral compression fractures appears 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, and also for people with symptomatic vertebral hemangioma and painful vertebral body tumors (metastases or myeloma), provided that normal arrangements are in place for consent, audit, and clinical governance. (48,49) The guidance recommends that the procedure be limited to patients whose pain is refractory to more conservative treatment.
A 2007 joint position from the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology (“the Societies”) states that, “percutaneous vertebral augmentation with vertebroplasty and kyphoplasty is a safe, efficacious, and durable procedure in appropriate patients with symptomatic osteoporotic and neoplastic fractures when performed in a manner in accordance with published standards. These procedures are offered only when traditional medical therapy has not provided pain relief or pain is substantially altering the patient’s lifestyle.” (50)
Guidelines from the American College of Radiology (ACR, 2006) consider percutaneous vertebroplasty appropriate for painful osteoporotic or neoplastic vertebral compression fracture(s) refractory to medical therapy. (51) It is noted that when fewer than 95% of percutaneous vertebroplasty in an institution are performed for the above indication, it should prompt a review of practices related to selection of patients for this procedure. The guidelines also list absolute contraindications of asymptomatic vertebral body compression fractures, including patient improving on medical therapy; nonfractured vertebral levels; prophylaxis in osteoporotic patients (unless being performed as part of a research protocol); osteomyelitis of the target vertebra; myelopathy originating at the fracture level; uncorrectable coagulopathy; allergy to bone cement or opacification agent. Relative contraindications are listed as radiculopathy in excess of local vertebral pain, caused by a compressive syndrome unrelated to vertebral collapse (occasionally preoperative percutaneous vertebroplasty can be performed before a spinal decompressive procedure); asymptomatic retropulsion of a fracture fragment causing significant spinal canal compromise; asymptomatic tumor extension into the epidural space; ongoing systemic infection.
Indications and contraindications similar to those provided by the ACR were described by the Society of Interventional Radiology (SIR) in 2003. (52)