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Percutaneous Vertebroplasty and Sacroplasty

Policy Number: MP-004

Latest Review Date: May 2019

Category: Radiology/Surgical                                               

Policy Grade:  B

DESCRIPTION OF PROCEDURE OR SERVICE:

Percutaneous vertebroplasty is an interventional technique involving the fluoroscopically guided injection of polymethylmethacrylate (PMMA) through a needle inserted into a weakened vertebral body. The technique has been investigated as an option to provide mechanical support and symptomatic relief in patients with osteoporotic vertebral compression fracture or in those with osteolytic lesions of the spine, i.e., multiple myeloma or metastatic malignancies. Percutaneous vertebroplasty has also been investigated as an adjunct to surgery for aggressive vertebral body hemangiomas, and as a technique to limit blood loss related to surgery.

Osteoporotic Fracture

Vertebral Compression Fracture

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 actually reach clinical diagnosis, and most symptomatic fractures will heal within a few weeks or 1 month. Nonetheless, some individuals with acute fractures will have severe pain and decreased function that interferes with ability to ambulate and is not responsive to usual medical management.

Treatment

Chronic symptoms do not tend to respond to the management strategies for acute pain such as bedrest, immobilization or 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. Improvements in pain and ability to function are the principal outcomes of interest for treatment of osteoporotic fractures.

Sacral Insufficiency Fractures

Sacral insufficiency fractures (SIFs) are the consequence of stress on weakened bone and often cause low back pain in the elderly population. Osteoporosis is the most common risk factor for SIF. Spontaneous fracture of the sacrum in patients with osteoporosis was described by Lourie in 1982 and presents as lower back and buttock pain with or without referred pain in the legs. Although common, SIFs can escape detection due to low provider suspicion and poor sensitivity on plain radiographs, slowing the application of appropriate intervention.

Treatment

Similar interventions are used for sacral and vertebral fractures and include bedrest, bracing, and analgesics. Initial clinical improvements may occur quickly; however, resolution of all symptoms may not occur for 9 to 12 months.

Vertebral/Sacral Body Metastasis

Metastatic malignant disease of the spine generally involves the vertebrae/sacrum, with pain being the most frequent complaint.

Treatment

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.

Percutaneous Vertebroplasty

Vertebroplasty is a surgical procedure that involves the injection of synthetic cement (e.g., polymethylmethacrylate [PMMA], bis-glycidal dimethacrylate [Cortoss]) into a fractured vertebra. 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.

Percutaneous Sacroplasty

Percutaneous sacroplasty evolved from the treatment of insufficiency fractures in the thoracic and lumbar vertebrae with vertebroplasty. The procedure, essentially identical, entails guided injection of PMMA through a needle inserted into the fracture zone. While first described in 2000 as a treatment for symptomatic sacral metastatic lesions, it is most often described as a minimally invasive procedure employed as an alternative to conservative management for sacral insufficiency fractures (SIFs). SIFs are the consequence of stress on weakened bone and are often the cause of low back pain among the elderly population. Osteoporosis is the most common risk factor for SIF.

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 and above 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 effects related to complications from vertebroplasty and sacroplasty are the primary harms to be considered. Principal safety concerns relate to the incidence and consequences of leakage of the injected PMMA or another injectate.

Vertebral Hemangiomas

Vertebral hemangiomas are relatively common lesions noted in up to 12% of the population based on autopsy series; however, only rarely do these lesions display aggressive features and produce neurologic compromise and/or pain. Treatment of aggressive vertebral hemangiomas has evolved from radiotherapy to surgical approaches using anterior spinal surgery for resection and decompression. There is the potential for large blood loss during surgical resection, and vascular embolization techniques have been used as adjuncts to treatment to reduce blood loss. Percutaneous vertebroplasty has been proposed as a way to treat and stabilize some hemangioma to limit the extent of surgical resection and as an adjunct to reduce associated blood loss from the surgery.

Kyphoplasty and mechanical vertebral augmentation are addressed separately in medical policy, #648- Percutaneous Balloon Kyphoplasty, Radiofrequency Kyphoplasty and Mechanical Vertebral Augmentation.

POLICY:

Percutaneous vertebroplasty may be considered medically necessary for the treatment of symptomatic osteoporotic vertebral fractures that have failed to respond to conservative treatment (e.g., analgesics, physical therapy, and rest) for at least six (6) weeks.

Percutaneous vertebroplasty may be considered medically necessary for the treatment of severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies.

Percutaneous vertebroplasty may be considered medically necessary for the treatment of vertebral hemangiomas with severe pain or nerve compression.

Percutaneous vertebroplasty is considered not medically necessary and investigational

for all other indications.

Percutaneous sacroplasty is considered not medically necessary and investigational for all indications, including use in sacral insufficiency fractures due to osteoporosis and spinal lesions due to metastatic malignancies or multiple myeloma.

KEY POINTS:

The most recent literature update for this policy was performed through February 18, 2019.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function- including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Percutaneous Vertebroplasty for Vertebral Compression Fractures between 6 Weeks and 1 Year Old

Clinical Context and Therapy Purpose

The purpose of vertebroplasty is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with symptomatic osteoporotic or osteolytic vertebral fractures between 6 weeks and 1 year old.

The question addressed in this evidence review is: does vertebroplasty improve the net health outcome in individuals with symptomatic osteolytic vertebral fractures between 6 weeks and 1 year old?

The following PICOTS were used to select literature to inform this review.

Patients

The relevant population of interest are individuals with symptomatic osteoporotic or osteolytic vertebral fractures between 6 weeks and 1 year old. With acute fractures, these individuals experience severe pain, decreased ambulatory function, and a lessened response to conservative medical management. Risk factors for osteoporotic or osteolytic vertebral fractures can include osteopenia, osteoporosis, advanced age, inactivity, corticosteroid use, female sex, and depression.

Interventions

The therapy being considered is vertebroplasty, a procedure for stabilizing compression fractures in the spine, during which bone cement is injected into the fractured vertebra through a small hole in the skin in order to relieve back pain. The vertebroplasty procedure is performed in an outpatient setting by interventional radiologists or orthopedic surgeons.

Comparators

Comparators of interest include conservative management. Conservative management includes measures to reduce pain and improve mobility. Physical therapy, analgesics, narcotics, and hormone treatments can be prescribed to achieve this. Bed rest and braces may also be utilized as conservative management; however, these modalities are associated with prolonged immobilization which can further exacerbate bone loss and fail to relieve systems. Patients who receive conservative management are typically managed by pediatricians, physical therapists, and primary care providers in an outpatient clinical setting.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, quality of life, hospitalizations, medication use, and treatment-related morbidity. Negative outcomes can include complications with sedation, further injury during transfer to the radiology table, and the possibility of abuse after the prescription of narcotics. The outcomes of interest for vertebroplasty as a treatment for symptomatic vertebral fractures have varying follow-up times to interest to fully examine the impact on the patient, ranging from shorter term outcomes like medication use to outcomes that require extended follow-up, such as functional outcomes. Given that the existing literature evaluating vertebroplasty as a treatment for symptomatic vertebral fractures between 6 weeks and 1 year old has varying lengths of follow up, ranging from 6 months to 2 years, follow-up timing of 1 year is appropriate to demonstrate efficacy.

Disability, a major factor on quality of life, is measured using various tools throughout the literature. Three such tools include the Roland-Morris Disability Questionnaire (RMDQ), the visual analogue scale (VAS), and QUALEFFO. The RMDQ is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale and on VAS. The RMDQ has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain. VAS is commonly used as the outcome measure for such studies. It is usually presented as a 100-mm horizontal line on which the patient’s pain intensity is represented by a point between the extremes of “no pain at all” and “worst pain imaginable.” With QUALEFFO, quality of life measured by the scale 0 to 100, higher scores indicating worse quality of life.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

  3. To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

Studies with duplicative or overlapping populations were excluded

This evidence review was originally informed by a 2000 TEC Assessment, which was updated periodically through 2010. Subsequent evidence includes a number of RCTs, 2 of which included a sham control, and numerous RCTs that compared vertebroplasty with conservative management. 

Systematic Reviews

Buchbinder et al (2018) published a Cochrane review of the literature up to November 2014. Studies compared vertebroplasty vs placebo (two 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 ranged from 1 week to more than 6 months. At one month, disease-specific quality of life measured by the QUALEFFO (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 three trials (one placebo, two 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 two placebo-controlled trials, it is unclear to what extent risk of other adverse events exist. 3/106 adverse events were observed in the vertebroplasty group compared with 3/103 in the placebo group; RR 1.01 (95% 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 (described below) to determine whether vertebroplasty is more effective than sham in specific subsets of patients. This subset analysis focused on duration of pain (≤6 weeks vs >6 weeks) and severity of pain (score <8 or ≥8 on an 11-point numeric rating scale [NRS]). 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 Roland-Morris Disability Questionnaire [RMDQ] at 1 month) did not differ significantly between groups. Responders’ analyses were also conducted based on a 3-unit improvement in pain scores, a 3-unit improvement on 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 (relative risk, 1.32; 95% CI, 0.98 to 1.76; p=0.07), 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. Thirteen studies were selected (N=1231 patients; 623 to vertebroplasty, 608 to conservative treatment); among them were the two sham-controlled trials described below. 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 (mean difference [MD], 1.36; 95% CI, 0.55 to 2.17) and 1 month (MD=1.56; 95% CI, 0.43 to 2.70); it was inferior to conservative treatment for pain relief at 6 months (MD = -1.59; 95% CI, -2.9 to -0.27; p<0.05). Vertebroplasty showed improvement over conservative treatment for quality of life, as measured using the Quality of Life Questionnaire of the European Foundation for Osteoporosis (MD = -5.03; 95% CI, 7.94 to -2.12). No statistically significant differences were found between treatments for the rate of adjacent-level vertebral fractures (relative risk: 0.59; 95% CI, 0.43 to 0.81). Limitations included the inclusion of several studies with inadequate blinding and heterogeneous reporting of patient characteristics outcomes.

Randomized Controlled Trials

Vertebroplasty vs Medical Management with Sham Controls

Two sham-controlled trials were published in 2009 and were included in the systematic reviews described above. The 2 RCTs compared vertebroplasty to medical management using a sham control (that included local anesthetic), which mimicked the vertebroplasty procedure up to the point of cement injection. Buchbinder et al reported results of 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. Patients were assigned to vertebroplasty or to 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. Blinding was maintained through 24-month follow-up of this trial.

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 three 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 reported no significant difference 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 vertebroplasty provided no benefit.

Kallmes et al (2009) 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). 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 one year post procedure. 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.

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.  By 1 year, 16% of patients who underwent vertebroplasty and 60% of control subjects had crossed over to the alternative procedure (p<0.001).  As-treated analysis found no significant difference in RMDQ or pain scores between the 2 groups. ITT analysis found a modest 1-point difference in pain rating, but no significant difference in RMDQ. 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 (2018) published the results of a randomized, double-blind, sham-controlled clinical trial performed in four community hospitals in the Netherlands from 2011 to 2015.

Participants included 180 persons requiring treatment for acute osteoporotic vertebral compression fractures that were randomized to either vertebroplasty (n=91) or a sham procedure (n=89). The main outcome measured was mean reduction in VAS scores at day one, one week, and one, three, six, 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. The mean difference in VAS scores between groups was 0.20 (95% confidence interval −0.53 to 0.94) at baseline, −0.43 (−1.17 to 0.31) at one day, −0.11 (−0.85 to 0.63) at one week, 0.41 (−0.33 to 1.15) at one month, 0.21 (−0.54 to 0.96) at three months, 0.39 (−0.37 to 1.15) at six months, and 0.45 (−0.37 to 1.24) at 12 months. These changes in VAS scores did not, however, differ statistically significantly between the groups during 12 months’ follow-up.

Vertebroplasty vs Medical Management without Sham Controls

Chen et al reported a nonblinded RCT of vertebroplasty compared with conservative management in 2014. The study included 89 patients with chronic compression fractures confirmed by magnetic resonance imaging (MRI) and persistent severe pain for three months or longer. Evaluation was performed at one week and at 1, 3, 6, and 12 months. Over the course of the 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<0.001). Complete pain relief was reported by 84.8% of patients in the vertebroplasty group compared with 34.9% of controls. The final Oswestry Disability Index score was 15.0 in the vertebroplasty group and 32.1 in the conservative management group (p<0.001), and the final RMDQ score was 8.1 for vertebroplasty and 10.7 for controls (p<0.001).

In 2011, Farrokhi et al reported blinded RCT that compared vertebroplasty with optimal medical management in 82 patients. Patients had painful osteoporotic vertebral compression fractures that were refractory to analgesic therapy for at least 4 weeks and less than 1 year. The patients and the physicians involved in the treatment were not aware of the treatment that the other group was receiving. 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, one patient experience epidural cement leakage, which cause severe lower extremity pain and weakness and had to be treated with bilateral laminectomy and evacuation of the bone cement. At 1 week, the mean VAS score decreased from 8.4 to 3.3 in the vertebroplasty group and from 7.2 to 6.4 in the conservative management group, with between-group differences that remained significant through 6 months of follow-up. Group differences on the ODI lower back pain score were significantly lower in the vertebroplasty group throughout the 36 months of the study. New symptomatic adjacent fractures developed in 1 (2.6%) patient in the vertebroplasty group and 6 (15.4%) patients in the conservative management group. In 1 patient, epidural cement leakage caused severe lower-extremity pain and weakness that was treated with bilateral laminectomy and evacuation of bone cement.

Nonrandomized Comparative Studies

In 2011 and 2015, Edidin et al reported mortality risk rates in Medicare patients who had vertebral compression fractures and had been treated with vertebroplasty, kyphoplasty or nonoperatively. 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 data set included 141,343 kyphoplasty patients and 75,364 vertebroplasty patients. Survival was calculated from the index diagnosis date until death or the end of follow-up (up to 4 years). Propensity matching was used to control for multiple covariates, which included age, sex, race, census region, socioeconomic status, comorbidities in 12 months prior to diagnosis, type of fracture, and year of fracture. The matched cohort included 100,649 non-operated 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 non-operated cohort had a 55% (95% CI, 53% to 56%, p<0.001) higher risk of mortality than the kyphoplasty cohort and a 25% (95% CI, 23% to 26%, p<0.001) higher mortality risk than the vertebroplasty cohort. After propensity matching, the risk of mortality at 4 years was 47.2% in the non-operated group compared to 42.3% in the kyphoplasty group (p<0.001) and 46.2% in the vertebroplasty group (p<0.001).

Lin et al reported on mortality risk in elderly patients (>70 years old) who had vertebral compression fractures and were treated with early vertebroplasty (within 3 months) or conservative therapy. 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<0.05). 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 non-vertebroplasty group was 0.63 per 100 person-months (95% CI, 0.57 to 0.70). With regard to respiratory failure, hazard ratio between groups was 1.46 (95% CI, 1.04 to 2.05; p=0.028). 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.

Section Summary: Percutaneous Vertebroplasty for Vertebral Compression Fractures between 6 Weeks and 1 year Old

Despite evidence from numerous RCTs, including 2 with sham controls, the efficacy of vertebroplasty for painful osteoporotic compression fractures of less than 1 year remains uncertain. Four meta-analysis studies are present, including an update, 3 of which include the 2 randomized, sham-controlled trials from 2009, but have mixed results. There remains some uncertainty related to the interpretation of these conclusions. While the use of a sham procedure is a major methodologic strength to control for nonspecific (placebo) effects, the sham used in the trial was not without controversy, given that the effect of injecting local anesthetic in the facet capsule and/or periosteum is unknown. Also, the appropriateness of outcome measures used to detect clinically meaningful differences in pain may not have been optimal, as the studies were underpowered to detect differences in clinical response rates. Questions have also been raised about the low percentage of patients screened who participated in the trial, the volume of polymethylmethacrylate (PMMA) injected, and the inclusion of patients with chronic pain.

Percutaneous Vertebroplasty for Vertebral Compression Fractures of Less than 6 Weeks Old

Clinical Context and Therapy Purpose

The purpose of vertebroplasty is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as conservative management, in patients with symptomatic osteoporotic vertebral fractures less than six weeks old.

The question addressed in this evidence review is: does vertebroplasty improve the net health outcome in individuals with symptomatic osteolytic vertebral fractures less than six weeks old?

The following PICOTS were used to select literature to inform this review.

Patients

The relevant population of interest are individuals with symptomatic osteoporotic vertebral fractures less than six weeks old. With acute fractures, these individuals experience severe pain, decreased ambulatory function, and a lessened response to conservative medical management.

Interventions

The therapy being considered is vertebroplasty, which is typically performed by an interventional radiologist in an outpatient clinical setting.

Comparators

Comparators of interest include conservative management. A detailed review of the comparators is listed in the above indication. Patients receiving conservative management are typically managed by physical therapists and primary care providers in an outpatient clinical setting.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, QOL, hospitalizations, medication use, and treatment-related morbidity. Symptoms can include back pain and demonstrated fracture on radiography. The most current research available tracks follow-up to twelve months or more. A number of studies have longer term follow-up at more than five years, which is ideal for understanding all of the outcomes, particularly the occurrence of new vertebral compression fractures after vertebroplasty.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

  3. To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

  4. Studies with duplicative or overlapping populations were excluded

Randomized Controlled Trials

Vertebroplasty vs Medical Management with Sham Controls

In 2016, Clark et al reported on results from the VAPOUR trial (see Table 1). 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 an NRS. Two authors had participated in the 2009 study published by Kallmes et al and the trial followed a similar protocol. Both outcomes assessors and patients were masked to treatment allocation, and independent statisticians unmasked the data and prepared the trial report. The sham-vertebroplasty procedure included subcutaneous lidocaine but no periosteal numbing. Manual skin pressure and tapping on the needle was performed to simulate the needle advance, and the investigators discussed PMMA mixing and injection during the procedure. The primary outcome (the percentage of patients with an NRS score <4 out of 10 at 14 days post procedure) 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 (see Table 1). The benefit of vertebroplasty was found predominantly in the thoracolumbar subgroup, with 48% (95% CI, 27% to 68%) more patients meeting the primary end point (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. Post procedural 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 vs 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. Of 431 patients eligible for randomization, 229 (53%) had spontaneous pain relief during assessment. Participants with at least one painful osteoporotic vertebral fracture of six weeks or less in duration were assigned to vertebroplasty or conservative management. The primary outcome was pain relief of three points measured on a 10-point VAS at one month and one year.

A total of 101subjects were enrolled into the treatment group and 101 into 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 (<0.001); there were significant between-group differences in mean VAS scores at 1 month (2.6; 1.74 to 3.37; p<0.001) and at 1 year (2.0; 1.13 to 2.80; p<0.001). 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). Surgically treated patients were discharged the next day. Patients treated conservatively (pain medication, bedrest, 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 operatively treated patients and at 2 months for 59.2% of conservatively treated patients. All patients were evaluated with radiographs and MRI 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 short report on a multicenter RCT enrolling 400 patients with osteoporotic thoracic or lumbar vertebral compression fractures who were treated with vertebroplasty or conservative therapy. 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=0.023) and ODI score improving from 53.6% to 31.7% (p=0.012). Sixty-five percent of patients treated with vertebroplasty had stopped all analgesic use within 48 hours. The conservatively 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 to 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. Vertebroplasty was performed at a mean of 8.4 days after pain onset. Patients in the conservative therapy group were placed on bedrest 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 post treatment while only 12 (23.5%) patients could stand up and walk after 2 weeks of bedrest. The average duration of bedrest from pain onset was 7.8 (SD=4.7) days (range, 2-15 days) in the vertebroplasty group compared to 32.5 (SD=14.3) 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 to the vertebroplasty group (16.1%; p<0.001). Complications included pneumonia, urinary tract infection, deep vein thrombosis, depression, and sleep disorders.

Section Summary: Percutaneous Vertebroplasty for Vertebral Compression Fractures of Less Than 6 Weeks Old

In a sham-controlled randomized trial, where no anesthetic was injected into the periosteum, there was a significant benefit of vertebroplasty in patients who had severe pain of less than 6 weeks in duration following vertebral fracture at the thoracolumbar junction. Other RCTs without sham controls have reported that vertebroplasty is associated with significant improvements in pain, earlier improvements in function, and reductions in the duration of bedrest compared to conservatively managed patients.

Percutaneous Sacroplasty

Clinical Context and Therapy Purpose

The purpose of sacroplasty is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as conservative management, in patients with sacral insufficiency fractures.

The question addressed in this evidence review is: does sacroplasty improve the net health outcome in individuals with sacral insufficiency fractures?

The following PICOTS were used to select literature to inform this review.

Patients

The relevant population of interest are individuals with sacral insufficiency fractures. Sacral insufficiency fractures are a stress fracture, resulting from a regular stress applied to a bone with reduced elasticity. Often, these fractures are associated with underlying metabolic bone disease condition like osteoporosis. Examples of risk factors include corticosteroid therapy use, female sex, pelvic radiation, rheumatoid arthritis, and hyperparathyroidism.

Interventions

The therapy being considered is sacroplasty, a minimally invasive procedure for treating pathological fractures of the sacral vertebral body or sacral ala. The procedure involves percutaneous insertion of one or more bone needles into the sacrum and injection of bone cement under fluoroscopy and/or computed tomography visual guidance. This intervention is provided by an interventional radiologist typically in an outpatient setting.

Comparators

Comparators of interest include conservative management. Conservative management includes physical therapy, analgesics, narcotics, and hormone treatments. Examples of conservative management for sacral insufficiency fractures are varied and can include bed rest and pain medication to early physical therapy.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, QOL, hospitalizations, medication use, and treatment-related morbidity. Possible negative outcomes include complications with sedation, cement leakage into the presacral space, spinal canal, sacral foramen, or sacroiliac joint, and possible spinal compression due to extravasation of cement. At least one year of follow-up is desirable to adequately evaluate outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

  3. To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

  4. Studies with duplicative or overlapping populations were excluded.

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. The largest prospective report is an observational cohort study of 52 consecutive patients undergoing sacroplasty for sacral insufficiency fractures using the short-axis technique.  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 post procedure. At each interval, statistically significant improvement over baseline was observed and maintained through 52 weeks.

The largest series is a retrospective multicenter analysis of 204 patients with painful sacral insufficiency fractures and 39 patients with symptomatic sacral lesions treated with either the short-axis or long-axis technique.  One hundred and sixty-nine patients had bilateral sacral insufficiency fractures and 65 patients had additional fractures of the axial skeleton. VAS 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 one 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 vs nonsurgical management. This prospective, observational cohort study spanned ten 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<0.001). However, the sacroplasty treatment group experienced significant VAS score improvement consistently at many of the follow-up points (pretreatment to post [p<0.001]; post treatment through 2 weeks [p>0.001]; 12 weeks through 24 weeks [p=0.014]; 24 weeks through 1 year [p=0.002]). Meanwhile, the group with nonsurgical treatment only experienced one significant pain improvement score—at the 2-week follow-up post treatment (p=0.002). One major limitation of this study was that the nonsurgical treatment group was not followed up with at the 10-year mark whereas the sacroplasty group did receive follow-up.

There are several retrospective reviews with about 50 patients each. One of these described a series of 57 patients treated with sacroplasty under computed tomography (CT) guidance for sacral insufficiency fractures.  The short- or long-axis approach was dictated by the length and type of the fracture and patient anatomy. Follow-up data at 2.5 weeks was available for 45 patients (79%), 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 outcome data, 37 (82%) were reported to have experienced either a numerical or descriptive decrease from initial pain of at least 30%.

There are complications related to 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. Performing sacroplasty only on zone 1 fractures can minimize these risks.

Section Summary: Percutaneous Sacroplasty

No RCTs on percutaneous sacroplasty for sacral insufficiency were identified. The available evidence includes two prospective cohort study with 52 patients and a retrospective series with 243 patients. These studies have reported rapid and sustained decreases in pain following percutaneous sacroplasty. Additional reports are mostly consistent in reporting immediate improvement following the procedure. Due to the limited number of patients and the retrospective nature of the evidence base, harms associated with sacroplasty have not been adequately studied. The small numbers of treated patients leave uncertainty regarding the impact of sacroplasty on health outcomes.

Vertebral Hemangiomas

For symptomatic vertebral body hemangioma with aggressive features, no studies reported pre- and post-procedure pain evaluations. Therefore, the findings of all studies that reported more than a single case (six studies, totaling 64 patients) were evaluated. The studies using percutaneous cementoplasty as an adjunct to surgical treatment suggest that the use of percutaneous cementoplasty to treat the vertebral body component of the vascular lesion may contribute to avoiding the substantial blood loss that has been historically described with primary surgical resection (curettage). However, the additional use of other procedures in these studies may make it difficult to attribute the lower blood loss to this procedure. These studies do not provide controlled comparisons of the morbidity of treating hemangiomas with percutaneous cementoplasty as an adjunct to surgery and the morbidity of surgical treatment without cementoplasty.

Cement leakage, although reduced in kyphoplasty relative to vertebroplasty, remains a concern. There continue to be case reports of right ventricle perforation, cardiac tamponade, and embolism of cement into pulmonary vessels.

Summary of Evidence

For individuals who have symptomatic osteoporotic vertebral fractures of between 6 weeks and 1 year old who receive vertebroplasty, the evidence includes 2 randomized sham-controlled trials, nonblinded randomized controlled trials (RCTs) comparing vertebroplasty with conservative management, and systematic reviews of these RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, hospitalizations, medication use, and treatment-related morbidity. Despite the completion of numerous RCTs, including 2 with sham controls, the efficacy of vertebroplasty for painful osteoporotic compression fractures remains uncertain. Two meta-analysis studies which included the 2 sham-controlled trials have demonstrated mixed results. The 2 studies had methodologic issues, including the choice of sham procedure and the potential effect of the sham procedure having a therapeutic effect by reducing pain. Questions have also been raised about the low percentage of patients screened who participated in the trial, the volume of polymethylmethacrylate injected, and the inclusion of patients with chronic pain. Overall, conclusions about the effect of vertebroplasty remain unclear. However, clinical input in 2008 provided uniform support for the use of vertebroplasty in painful osteoporotic fractures. After consideration of the available evidence and input, the consistent results of numerous case series, including large prospective reports, were sufficient to determine that vertebroplasty was a reasonable treatment option in patients with vertebral fractures who have failed to respond to conservative treatment (at least 6 weeks with analgesics, physical therapy, and rest). It is also clinically reasonable to consider the evidence supporting the clinical benefit of vertebroplasty in osteoporotic vertebral fracture to support its use in osteolytic lesions of the spine (e.g., multiple myeloma, metastatic malignancies).

For individuals with symptomatic osteoporotic vertebral fractures less than 6 weeks old who receive vertebroplasty, the evidence includes a randomized sham-controlled trial and other nonblinded RCTs comparing vertebroplasty with conservative management. Relevant outcomes are symptoms, functional outcomes, quality of life, hospitalizations, medication use, and treatment-related morbidity. For acute fractures, conservative therapy consisting of rest, analgesics, and physical therapy is an option, and symptoms will resolve in a large percentage of patients with conservative treatment only. However, a sham-controlled randomized trial in patients who had severe pain of less than 6 weeks in duration found a significant benefit of vertebroplasty for the treatment of osteoporotic vertebral fracture at the thoracolumbar junction. Other RCTs without sham controls have reported that vertebroplasty is associated with significant improvements in pain and reductions in the duration of bedrest. Given the high morbidity associated with extended bedrest in older adults, this procedure is considered to have a significant health benefit. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals with sacral insufficiency fractures who receive sacroplasty, the evidence includes two prospective cohort studies, several retrospective reviews, and a case series. Relevant outcomes are symptoms, functional outcomes, quality of life, hospitalizations, medication use, and treatment-related morbidity. No RCTs have been reported. The available evidence includes a prospective cohort study and a retrospective series with 243 patients. These studies have reported rapid and sustained decreases in pain following percutaneous sacroplasty. Additional literature has mostly reported immediate improvements following the procedure. However, due to the small size of the evidence base, the harms associated with sacroplasty have not been adequately studied. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

American College of Radiology et al

The American College of Radiology and 4 other medical specialty associations updated a 2012 joint position statement on percutaneous vertebral augmentation in 2014. The statement indicated that percutaneous vertebral augmentation with the use of vertebroplasty or kyphoplasty is a safe, efficacious, and durable procedure in appropriate patients with symptomatic osteoporotic and neoplastic fractures, when performed in accordance with public standards. The document also stated that these procedures are offered only when nonoperative medical therapy has not provided adequate pain relief, or pain is significantly altering patients’ quality of life.

American College of Radiology

The American College of Radiology (2018) revised its ACR Appropriateness Criteria for the use of percutaneous vertebral augmentation in the management of vertebral compression fractures. Table 1 shows the appropriateness categories for each variant.

Table 15. ACR Appropriateness Criteria for the use of Percutaneous Vertebral Augmentation for the Management of Vertebral Compression Fractures

Variants

Appropriateness Category

"New symptomatic compression fracture identified on radiographs or CT. No known malignancy."

May Be Appropriate

"Osteoporotic compression fracture, with or without edema on MRI and no ‘red flags.' With or without spinal deformity, worsening symptoms, or pulmonary dysfunction."

Usually Appropriate

"Asymptomatic pathologic spinal fracture with or without edema on MRI."

May Be Appropriate

"Pathologic spinal fracture with severe and worsening pain."

Usually Appropriate

"Pathologic spinal fracture with spinal deformity or pulmonary dysfunction."

Usually Appropriate

CT: computed tomography; MRI: magnetic resonance imaging; ACR: American College of Radiology.

Society for Interventional Radiology

The Society of Interventional Radiology (2014) issued a joint position statement with 7 other societies on percutaneous vertebral augmention noting that "percutaneous vertebral augmentation (PVA) with the use of 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." The society states that percutaneous vertebral augmentation should be "offered only when nonoperative medical therapy has not provided adequate pain relief or pain is significantly altering the patient's quality of life." Finally, the society notes that "the benefits of PVA outweigh its risk and the risks of non-operative medical therapy, and the success rate in appropriately selected patients is consistently high."

In a 2014 quality improvement guideline from SIR, failure of medical therapy is defined as follows:

  1. A patient rendered nonambulatory as a result of pain from a weakened or fractured vertebral body, pain persisting at a level that prevents ambulation despite 24 hours of analgesic therapy;

  2. A patient with sufficient pain from a weakened or fractured vertebral body that physical therapy is intolerable, pain persisting at that level despite 24 hours of analgesic therapy; or

  3. Any patient with a weakened or fractured vertebral body, unacceptable side effects such as excessive sedation, confusion, or constipation as a result of the analgesic therapy necessary to reduce pain to a tolerable level.

American Academy of Orthopaedic Surgeons

The American Academy of Orthopaedic Surgeons (AAOS) approved practice guidelines (2010) on the treatment of osteoporotic spinal compression fractures. AAOS 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.” With this recommendation, AAOS expressed its confidence that future evidence is unlikely to overturn the existing evidence. These recommendations were based on a literature review through September 2009; therefore, the 2010 Klazen trial was not considered.

National Institute for Health and Care Excellence

The U.K.’s National Institute for Health and Care Excellence (NICE) concluded in its 2003 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 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 o 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. This guidance indicated that vertebroplasty or kyphoplasty should be considered for “patients who have vertebral metastases and no evidence of MSCC [metastatic spinal cord compression] or spinal instability if they have: mechanical pain resistant to conventional pain management, or vertebral body collapse.”

U.S Preventive Services Task Force Recommendations

Not applicable.

 

KEY WORDS:

Percutaneous vertebroplasty, vertebroplasty, polymethylmethacrylate, PMMA, osteoporosis, vertebral body compression fracture, vertebral fracture, vertebral compression fracture, PV, VCF, optiplasty, OptiMesh, Arcuate XP device, Arcuplasty, ARCUATE™ Vertebral Augmentation System, sacroplasty, Cortoss Bone Augmentation Material, Osteopal, SpineFix, Parallax Contour Vertebral Augmentation device

 

APPROVED BY GOVERNING BODIES:

Vertebroplasty is a surgical procedure and, as such, is not subject to U.S. Food and Drug Administration (FDA) approval.

Polymethylmethacrylate (PMMA) bone cement was available as a drug product before enactment of FDA’s device regulation and was at first considered what 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 October 1999, PMMA 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 PMMA in vertebroplasty represented an off-label use of an FDA-regulated product before 2005. In 2005, PMMA bone cements such as Spine-Fix® Biomimetic Bone Cement and Osteopal® V were issued 510(k) marketing clearance for the fixation of pathologic fractures of the vertebral body using vertebroplasty procedures.

The use of PMMA in sacroplasty represents an off-label use of an FDA-regulated product (bone cements such as Spine-Fix® Biomimetic Bone Cement [Teknimed] and Osteopal® V [Heraeus]), as the 510(k) marketing clearance was for the fixation of pathologic fractures of the vertebral body using vertebroplasty procedures. Sacroplasty was not included.

In May 2009, Cortoss® (Stryker) Bone Augmentation Material was cleared for marketing by FDA through the 510(k) process. Cortoss® is a nonresorbable synthetic material that is a composite resin-based, bis-glycidal dimethacrylate. FDA classifies this product as a PMMA bone cement.

In February 2010, the Parallax® Contour® Vertebral Augmentation Device (ArthroCare) was cleared for marketing by FDA through the 510(k) process. The device creates a void in cancellous bone that can then be filled with bone cement.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING: 

CPT Codes:

01936

Anesthesia for percutaneous image guided procedures on the spine and spinal cord; therapeutic

0200T

Percutaneous sacral augmentation (sacroplasty), unilateral injection(s), including the use of a balloon or mechanical device, when used, one or more needles, includes imaging guidance and bone biopsy, when performed

0201T

         ; two or more needles includes imaging guidance and bone biopsy, when performed

22510

Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; cervicothoracic

22511

Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; lumbosacral

22512

Percutaneous vertebroplasty (bone biopsy included when performed), 1 vertebral body, unilateral or bilateral injection, inclusive of all imaging guidance; each additional cervicothoracic or lumbosacral vertebral body (List separately in addition to code for primary procedure)

64999

Unlisted procedure, nervous system

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  61. Jarvik, Jeffrey G., et al.  Vertebroplasty.  Learning more, but not enough, SPINE, Vol. 28, No. 14, pp. 1487-1489.

  62. Jarvik JG, Deyo RA.  Cementing the evidence; time for a randomized trial of vertebroplasty.  Am J Neuroradiol. Sep 2000; 21(8):1373-1374. 

  63. Kallmes DF, Comstock BA, Heagerty PJ et al.  A randomized trial of vertebroplasty of osteoporotic spinal fractures.  N Engl J Med. Aug 6 2009; 361(6):569-579.

  64. Katz J, Melzack R. Measurement of pain. Surg Clin North Am. 1999 Apr;79(2):231-252.

  65. Kaufmann, Timothy J., et al.  Age of fracture and clinical outcomes of percutaneous vertebroplasty, American Journal of Neuroradiology, Nov-Dec 2001, Vol. 22, pp. 1860-1863.

  66. Kelekis, Alexis D.  Radicular pain after vertebroplasty, SPINE, Vol. 28, No. 14, pp. E265-E269.

  67. Klazen CA, Lohle PN, de Vries J et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet 2010; 376(9746):1085-1092.

  68. Kortman K, Ortiz O, Miller T et al. Multicenter study to assess the efficacy and safety of sacroplasty in patients with osteoporotic sacral insufficiency fractures or pathologic sacral lesions. J Neurointerv Surg. Sep 2013; 5(5):461-466.

  69. Kroon F, Staples M, Ebeling PR, et al. Two-year results of a randomized placebo-controlled trial of vertebroplasty for acute osteoporotic vertebral fractures. J Bone Miner Res. Jun 2014;29(6):1346-1355.

  70. Kruger, Randell and Faciszewski, Thomas.  Radiation dose reduction to medical staff during vertebroplasty, SPINE, Vol. 28, No. 14, pp. 1608-1613.

  71. Lane JM, Johnson CE, et al.  Advances in spine surgery: minimally invasive options for the treatment of osteoporotic vertebral compression factors.  Orthopedic Clinics of North America 33(2):2002.

  72. Lavelle WF, Lavell ED, Smith HS.  Interventional techniques for back pain. Clin Geriatr Med 2008;24(2):345-368, viii.

  73. Layton KF, Thielen KR, Koch CA et al. Vertebroplasty, first 1000 levels of a single center: evaluation of the outcomes and complications. AJNR Am J Neuroradiol 2007; 28(4):683-689.

  74. Leali PT, Solla F, Maestretti G, et al. Safety and efficacy of vertebroplasty in the treatment of osteoporotic vertebral compression fractures: a prospective multicenter international randomized controlled study. Clin Cases Miner Bone Metab. Sep-Dec 2016;13(3):234-236.

  75. Leroux JL, Denat B, Thomas E et al. Sacral insufficiency fractures presenting as acute low-back pain. Biomechanical aspects. Spine (Phila Pa 1976) 1993; 18(16):2502-2506.

  76. Lewis CA, Barr JD, Cardella JF, et al.  ACR practice guideline.  Practice guideline for the performance of percutaneous vertebroplasty.  American College of Radiology Standards 2000-2001. Amended 2006;135-144. 

  77. Lieberman I.H., Dudeney S., Reinhard M.K., and Bell G.  Initial outcome of efficacy of “kyphoplasty” in the treatment of painful osteoporotic vertebral compression fractures, Spine: 26(14); 1631-1638.

  78. Lin JH, Chien LN, Tsai WL, et al. Early vertebroplasty associated with a lower risk of mortality and respiratory failure in aged patients with painful vertebral compression fractures: a population-based cohort study in Taiwan. Spine J. Sep 2017;17(9):1310-1318.

  79. Lin J, Lachmann E, Nagler W. Sacral insufficiency fractures: a report of two cases and a review of the literature. J Womens Health Gend Based Med 2001; 10(7):699-705.

  80. Lourie H. Spontaneous osteoporotic fracture of the sacrum: an unrecognized syndrome of the elderly. JAMA 1982;248(6):715-717.

  81. Marcy PY, Palussiere J, Descamps B, et al. Percutaneous cementoplasty for pelvic bone metastasis. Support Care Cancer 2000;8(6):500-503.

  82. Masala S, Massari F, Assako OP et al. Is 3T-MR spectroscopy a predictable selection tool in prophylactic vertebroplasty? Cardiovasc Intervent Radiol. Dec 2010; 33(6):1243-1252.

  83. Mathis, John M., et al.  Percutaneous vertebroplasty:  A developing standard of care for vertebral compression fractures, AJNR, February 2001, Vol. 22, pp. 373-381.

  84. McGraw JK, Cardella J, Barr JD, et al.  Standards of practice. Society of Interventional Radiology quality improvement guidelines for percutaneous vertebroplasty. J Vasc Interv Radiol 2003;14:827-831. 

  85. McGuire RAJ. AAOS Now: Treating spinal compression fractures. 2010; https://www.aaos.org/AAOSNow/2010/Oct/cover/cover1/?ssopc=1.

  86. Medical Policy Reference Manual.  Percutaneous vertebroplasty and kyphoplasty, Blue Cross and Blue Shield Association.  6.01.25. May 2001.

  87. Molloy, Sean, Mathis, John M., and Belkoff, Stephen M.  The effect of vertebral body percentage fill on mechanical behavior during percutaneous vertebroplasty, SPINE, Vol. 28, Vol. 14, pp. 1549-1554.

  88. Moerman DE, Jonas WB.  Deconstructing the placebo effect and finding the meaning of response.  Ann Intern Med. Mar 19 2002; 136(6):471-476.

  89. National Institutes of Health. Consensus statement. Bethesda, MD: National Institutes of Health; 2000:17:1.

  90. National Institute for Health and Clinical Excellence (NICE). CG 75 Metastatic spinal cord compression, diagnosis and management of adults 2008. https://publications.nice.org.uk/metastatic-spinal-cord-compression-cg75.

  91. National Institute for Health and Clinical Excellence (NICE), Guidance on balloon kyphoplasty for vertebral compression fractures.  IP Guidance Number:  IPG166; April 2006.  http://www.nice.org.uk/nicemedia/pdf/IPG166A4Updated.pdf. 

  92. National Institute for Health and Clinical Excellence (NICE).  Percutaneous cementoplasty for palliative treatment of bony malignancies.  IP Guidance Number:  IPG179.  Issue date:  June 2006.  https://www.nice.org.uk/nicemedia/pdf/ip/IPG179guidance.pdf.

  93. National Institute for Health and Care Excellence (NICE). IPG 12: Percutaneous vertebroplasty. 2003. https://publications.nice.org.uk/percutaneous-vertebroplasty-ipg12.

  94. National Institute for Health and Clinical Excellence (NICE). TA 279 Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures. 2013. https://publications.nice.org.uk/percutaneous-vertebroplasty-and-percutaneous-balloon-kyphoplasty-for-treating-osteoporotic-vertebral-ta279.

  95. Newhouse KE, el-Khoury GY, Buckwalter JA. Occult sacral fractures in osteopenic patients. J Bone Joint Surg Am. Dec 1992; 74(10):1472-1477.

  96. Ostelo RW, Deyo RA, Stratford P et al.  Interpreting change scores for pain and functional status in low back pain:  towards international consensus regarding minimal important change.  Spine. Jan 1 2008;33(1):90-94.

  97. Peh, W.C.G., and Gilna, C.A.  Percutaneous vertebroplasty:  Indications, contraindications, and technique, British Journal of Radiology, January 2003, Vol. 76, pp. 69-75.

  98. Peh, Wilfred C.G., et al.  Percutaneous vertebroplasty:  Treatment of painful vertebral compression fractures with intraosseous vacuum phenomena, AJR, May 2003, Vol. 180, 1411-1417.

  99. Perez-Higueras, A., et al.  Percutaneous vertebroplasty:  Long-term clinical and radiological outcome, Neuroradiology, 2002, Vol. 44, pp. 950-954.

  100. Pommersheim W, Huang-Hellinger F, Baker M, et al. Sacroplasty: a treatment for sacral insufficiency fractures: case report. AJNR Am J Neuroradiol 2003;24:1003.

  101. Reidy, Declan, Ahn, Henry, et al.  A biomechanical analysis of intravertebral pressures during vertebroplasty of cadaveric spines with and without simulated metastases, SPINE, Vol. 28, No. 14, pp. 1534-1539.

  102. Rousing R, Andersen MO, Jespersen SM et al.  Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures: three-month follow-up in a clinical randomized study.  Spin (Phila Pa 976). Jun 1 2009; 34(13):1349-1354. 

  103. Schofer MD, Efe T, Timmesfeld N et al.  Comparison of kyphoplasty and vertebroplasty in the treatment of fresh vertebral compression fractures.  Arch Orthop Trauma Surg 2009;129(10):1391-1399.

  104. Senn S. (2007).  Statistical Issues in Drug Development.  NY:  Wiley and Sons; 2007. 

  105. Staples MP, Kallmes DF, Comstock BA et al. Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: meta-analysis. BMJ 2011; 343:d3952.

  106. Stratford PW, Binkley J, Solomon P, et al. Defining the minimum level of 3

  107. Suparna HC, Vadhiraja BM, Apsani RC, et al.  Symptomatic vertebral hemangiomas—results of treatment with radiotherapy.  Indian J Radiol Imaging 2006;16:37-40.

  108. Tanner SB.  Back pain, vertebroplasty, and kyphoplasty: treatment of osteoporotic vertebral compression fractures.  Bulletin on the Rheumatic Diseases 52(2).

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  110. Vase L, Riley JL 3rd, Price DD.  A comparison of placebo effects in clinical analgesic trials versus studies of placebo analgesia.  Pain. Oct 2002; 99(3):443-452.

  111. Venmans A, Klazen CA, Lohle PN et al. Natural History of Pain in Patients with Conservatively Treated Osteoporotic Vertebral Compression Fractures: Results from VERTOS II. AJNR Am J Neuroradiol. Nov 24 2011.

  112. Voormolen MH, Mali WP, Lohle PN et al. Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS study. AJNR Am J Neuroradiol. Mar 2007; 28(3):555-560.

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POLICY HISTORY:

Medical Policy Group, November 1999

Medical Review Committee, January 2000

TEC Review, April 2000

Medical Policy Group, January 2001

Medical Review Committee, March 2001

TEC Review, May 2001

Medical Policy Group, February 2002 (2)

Medical Review Committee, March 2002

Available for Comment April 15-May 29, 2002

Medical Policy Group, June 2003 (2)

Medical Review Committee, June 2003

Medical Review Committee, July 2003

Medical Policy Administration Committee, July 2003

Available for comment July 28-September 10, 2003

Medical Policy Group, August 2003 (2)

Medical Review Committee, September 2003

Medical Policy Administration Committee, October 2003

Available for comment October 7-November 20, 2003

Medical Policy Group, October 2005 (2)

Medical Policy Administration Committee, November 2005

Available for comment November 30, 2005-January 13, 2006

Medical Policy Group, July 2006 (1)

Medical Policy Administration Committee, July 2006

Available for comment July 18-August 31, 2006

Medical Policy Group, January 2007 (2)

Medical Policy Group, June 2007 (2)

Medical Policy Group, July 2007 (2)

Medical Policy Administration Committee, July 2007

Available for comments July 16-September 3, 2007

Medical Policy Group, March 2008 (2)

Medical Policy Administration Committee, April 2008

Available for comment April 4-May 18, 2008

Medical Policy Group, May 2008 (2)

Medical Policy Administration Committee, June 2008

Available for comment June 11-July 26, 2008

Medical Policy Group, June 2009 (2)

Medical Policy Administration Committee, July 2009

Available for comment July 1-August 14, 2009

Medical Policy Panel, February 2010

Medical Policy Group, March 2010 (2)

Medical Policy Administration Committee, April 2010

Available for comment April 12-May 26, 2010

Medical Policy Panel, February 2011

Medical Policy Group, June 2011 (2): Key Points and Reference Updated

Medical Policy Group, December 2011 (3): Updated verbiage on CPT 22520 & 22521 for 2012 code update.

Medical Policy Panel, April 2013

Medical Policy Group, August 2013 (2): Title change to include Mechanical Vertebral Augmentation.   Policy statement added that all other percutaneous mechanical vertebral augmentation devices, including but not limited to Kiva are investigational.   Description, Key Points, Approved by Governing Bodies, Key Words, and Reference updated to support new policy statement and literature search.  

Medical Policy Administration Committee, September 2013

Available for comment September 19 through November 2, 2013

Medical Policy Group, March 2014 (2): Corrected policy statement with addition of coverage for vertebral hemangiomas with severe pain or nerve compression.

Medical Policy Group, March 2014 (5): Added ICD-9 and ICD-10-CM diagnosis under Coding; no change to policy statement.

Medical Policy Panel, July 2014

Medical Policy Group, July 2014 (3):  2014 Updates to Key Points, Governing Bodies & References; no change in policy statements; removed policy statements for 2010 & prior years

Medical Policy Group, November 2014 (3): 2015 Annual Coding update; added CPT codes 22510-22515 and moved previous codes 22520-22525 and 72291-72292; changed verbiage on 0200T & 0201T by adding ‘includes imaging guidance and bone biopsy, when performed.

Medical Policy Panel, April 2015

Medical Policy Group, May 2015 (2): 2015 Updates to Description, Key Points, Current Coding, and References; no change to policy statement. 

Medical Policy Group, November 2015:  2016 Annual Coding Update; Moved HCPCS codes S2360 and S2361 from current coding to previous coding.

Medical Policy Panel, November 2016

Medical Policy Group, November 2016 (7): 2016 Updates to Key Points, Coding- Removed previous codes deleted in 2006 and ICD-9 and ICD-10-CM diagnosis under Coding Section. No change to policy statement.

Medical Policy Panel, April 2018

Medical Policy Group, April 2018 (7): 2018 Updates to Title, Description, Key Points, Key Words, Approved by Governing Bodies and References; removed all aspects of kyphoplasty and mechanical augmentation, now in separate policy, #648. Policy Statement clarified- removed “including use in acute vertebral fractures due to osteoporosis or trauma”. No change in intent.

Medical Policy Panel, April 2019

Medical Policy Group, May 2019 (7): Updates to Key Points and References. No change in Policy Statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.