Medical Policy

 

Subject: Percutaneous Vertebroplasty, Kyphoplasty and Sacroplasty
Document #: SURG.00067 Publish Date:    10/17/2018
Status: Reviewed Last Review Date:    09/13/2018

Description/Scope

 

This document addresses percutaneous vertebroplasty, percutaneous kyphoplasty and percutaneous sacroplasty. These are interventional procedures which involve the injection of bone cement into insufficiency and pathologic compression fractures with the goal of relieving pain, improving mobility, and preventing further collapse of the bone.

 

Position Statement

Medically Necessary:

Percutaneous vertebroplasty or kyphoplasty of the cervical, lumbar or thoracic region is considered medically necessary after failure of standard medical therapy when any of the following criteria are met:

Investigational and Not Medically Necessary:

Percutaneous vertebroplasty or kyphoplasty of the cervical, lumbar or thoracic region is considered investigational and not medically necessary for all uses that do not meet the criteria identified as medically necessary listed above.

Percutaneous sacroplasty is considered investigational and not medically necessary for all indications. 

Rationale

Percutaneous Vertebroplasty

Percutaneous vertebroplasty has been used in the United States since the early 1990’s for the management of osteoporotic vertebral compression fractures (ACR, 2014). In addition to osteoporosis, other causes of vertebral compression fractures include neoplasms or acute trauma to a previously healthy spine. Multiple studies have demonstrated that vertebroplasty may result in relief of pain. However, medical management is traditionally the first-line treatment of painful vertebral compression fractures.

Early case series and primarily uncontrolled retrospective studies reported that percutaneous vertebroplasty significantly reduced pain and improved mobility in the majority of individuals, with few experiencing persistent mild pain (Amar, 2001; Brown, 2004; Kaufmann, 2001; Knavel, 2008; Kim, 2002; McGraw, 2002; Ramos, 2006; Vasconcelos, 2002). A large prospective case series (Layton, 2007) reported similar outcomes from a database of 552 subjects (1000 compression fractures) at a single large academic department. All subjects treated with vertebroplasty were included, regardless of the underlying pathologic cause. Results from the majority of these case series and studies indicate percutaneous vertebroplasty can produce significant pain relief, increase mobility, and improve quality of life in the majority of individuals with osteolytic lesions from hemangiomas, metastases or myeloma, or osteoporotic compression fractures. Pain relief was apparent within 1 to 2 days after injection and persisted for at least several months and up to several years. Complications were relatively rare with a higher rate in individuals with malignant processes, due primarily to leakage of cement from extensive lytic regions in the vertebral bodies and to the poor overall health status of these individuals. Of these studies, Ramos and colleagues (2006) specifically included plasmacytomas (which may turn into multiple myeloma) in their evaluation of percutaneous vertebroplasty for multiple myeloma.

Buchbinder and colleagues (2009) randomized 78 individuals with one or two painful osteoporotic vertebral fractures to undergo either vertebroplasty (investigational group) or a sham procedure (control group). A total of 71 individuals completed the 6 month follow-up (n=35 investigational group; n=36 control group). The primary outcome was pain, as measured on a 10 point pain scale. There was no significant difference in pain between the two groups at any time point with both groups reporting significant reductions in pain.

Kallmes and colleagues (2009) reported results of a randomized controlled blinded crossover study comparing vertebroplasty (n=68; investigational group) with a sham procedure (n=63; control group). The primary outcome was pain assessed on a 10 point scale and scores on the Roland-Morris Disability Questionnaire (RDQ). The RDQ consists of a scale from 0 to 23 with higher scores indicating higher disability. At 1 month there was no significant difference between the two groups with both having similar improvements in pain and disability. After the initial assessment, subjects were allowed to cross over to the alternate treatment; by 3 months, 8 individuals (12%) in the percutaneous vertebroplasty group and 27 individuals (43%) in the control group had crossed over to the alternative treatment. The reason for the higher crossover rate from the control group is unclear since the pain scores were similar among those who did and did not cross over. The authors concluded that improvements in pain-related disability associated with osteoporotic compression fractures in individuals treated with vertebroplasty were similar to those treated with a sham procedure.

The North American Spine Society (NASS) reviewed the Buchbinder and Kallmes studies and commented in October 2009. In their analysis, NASS focused on candidate selection in the areas of fracture acuity, enrollment, control group and outcomes. For fracture acuity, NASS pointed out that there appeared to be inconsistency regarding the definition and timeframe of an acute fracture. As for the enrollment procedure, in the Kallmes study, 1812 participants were initially screened, but only 131 entered the study. Likewise, in the Buchbinder study, 141 candidates, who fulfilled inclusion criteria, declined randomization. In both studies, the control group was given a sham treatment, which was an anesthetic injection that could have provided pain relief, but it was unclear if the pain was originating from an osteoporotic vertebral compression fracture. The outcomes were based on measurements of ‘back pain’ but since the back pain origin was not clear, the accuracy of the measurements could have led to questionable conclusions.

Klazen and colleagues (2010a) reported results of a multicenter (6) prospective randomized trial investigating percutaneous vertebroplasty for the treatment of osteoporotic vertebral compression fractures. Participants were 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss; level of fracture at T5 or lower; bone edema on magnetic resonance imaging [MRI]), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Individuals were randomly allocated to percutaneous vertebroplasty or conservative treatment by computer-generated randomization codes with a block size of six. Blinding was not possible by the nature of the treatment under study. The primary outcome was pain relief at 1 month and 1 year as measured by VAS score. A total of 202 subjects with persistent pain were randomly allocated to vertebroplasty (n=101) or conservative treatment (n=101). Vertebroplasty resulted in greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was -5.2 (-5.88 to -4.72) after vertebroplasty and -2.7 (-3.22 to -1.98) after conservative treatment, and between baseline and 1 year was -5.7 (-6.22 to -4.98) after vertebroplasty and -3.7 (-4.35 to -3.05) after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2.6 (1.74-3.37, p<0.0001) at 1 month and 2.0 (1.13-2.80, p<0.0001) at 1 year. No serious complications or adverse events were reported.

Klazen and colleagues (2010b) examined the occurrence of new vertebral compression fractures (VCFs) after vertebroplasty. Incidence, distribution, and timing of new VCFs during follow-up were assessed from spine radiographs, and also further height loss in treated vertebral fractures was measured. After a mean follow-up of 11.4 months (median, 12.0; range, 1-24 months), 18 new VCFs occurred in 15 of 91 participants after vertebroplasty and 30 new VCFs in 21 of 85 participants after conservative therapy. This difference was not significant (p=0.44). There was no higher fracture risk for adjacent-versus-distant vertebrae. Mean time to new VCF was 16.2 months after percutaneous vertebroplasty and 17.8 months after conservative treatment. The baseline number of VCFs was the only risk factor for occurrence and number of new VCFs (odds ratio [OR], 1.43; 95% confidence interval [CI], 1.05-1.95, p=0.01). After conservative therapy, further height loss of treated vertebrae occurred more frequently (35 of 85 versus 11 of 91 subjects, p<0.001) and was more severe (p<0.001) than after percutaneous vertebroplasty. Incidence of new VCFs was not different after percutaneous vertebroplasty compared with conservative therapy after a mean of 11.4 months' follow-up. The authors concluded that percutaneous vertebroplasty contributed to preservation of stature by decreasing both the incidence and severity of further height loss in treated vertebrae.

Chew and colleagues (2011) performed a systematic review of the safety and efficacy of vertebroplasty in malignancy. Thirty studies (987 individuals) were identified, including a single randomized controlled trial and seven prospective studies. Most centers reported treating no more than four vertebrae per session. Pain reduction ranged from 20% to 79%. Five deaths were attributed to vertebroplasty, two from chest infections following general anesthesia, one from a cement pulmonary embolus, and two from sepsis after emergency spinal decompression. Another 19 individuals suffered a serious complication related to the procedure, with 13 requiring emergency spinal decompression. Reports of complications occurred in studies with a mean cement volume of more than 4 mL, suggesting a possible association between the volumes of cement injected and adverse events. The authors report that vertebroplasty for malignancy is an attractive assistant to radiotherapy or chemotherapy due to its rapid efficacy in those with intractable pain. Additionally, they noted that kyphoplasty has also been performed for individuals with spinal metastasis and myeloma. However, no good evidence was reported showing superiority of one procedure over another. Sacroplasty was not addressed in this review.

Blasco and colleagues (2012) reported on a prospective, controlled, randomized single-center trial designed to compare the effects of vertebroplasty versus conservative treatment on improving pain and quality of life in those with painful osteoporotic vertebral fractures. Secondary adverse effects were also analyzed over a 1-year follow-up period. A total of 125 individuals were randomly assigned to receive vertebroplasty or conservative treatment. The primary endpoint was comparison of quality of life (Quality of Life Questionnaire of the European Foundation for Osteoporosis [Qualeffo-41] and pain (Visual Analogue Scale [VAS]) during a 12 month follow-up. Secondary outcomes included comparison of analgesic consumption, clinical complications, and radiological vertebral fractures. Both treatment arms showed significant improvement in VAS scores at all time points, with greater improvement in the vertebroplasty group at the 2-month follow-up. Significant improvement in Qualeffo total score was seen in the vertebroplasty group throughout the study; however, this was not seen in the conservative treatment arm until the 6-month follow-up. Vertebroplasty treatment was associated with an increased incidence of vertebral fractures (odds ratio [OR], 2.78; 95% CI, 1.02-7.62; p=0.0462). The authors concluded that vertebroplasty and conservative treatment were both associated with significant improvement in pain and quality of life in individuals with painful osteoporotic vertebral fractures over a 1-year follow-up period. There were no statistically significant differences in mortality between the two groups. Individuals treated with vertebroplasty showed greater pain relief with significant improvement in the pain score at the 2-month follow-up, although it was associated with an increased incidence of vertebral fractures. Further effort to address the selection of individuals most likely to benefit from vertebroplasty with the lowest risk of complications was recommended.

In 2014, Chen and colleagues reported results of a single center randomized study that compared vertebroplasty (n=46) to conservative treatment (n=50) for pain relief and functional outcomes. The study consisted of 96 individuals with chronic osteoporotic compression spinal fractures confirmed by MRI and persistent severe pain for 3 months or longer. Conservative treatment included hospitalization, bracing, analgesia, physiotherapy and osteoporotic medication treatment (vitamin D and diphosphonate). Evaluations were performed at 1 week and at 1, 3, and 6 months and 1 year. The 1 year follow-up was completed by 89 subjects. During the year follow-up period, pain scores decreased from 6.5 to 2.5 in the vertebroplasty group and from 6.4 to 4.1 in the control group. Complete pain relief was reported by 84.8% of subjects in the vertebroplasty group compared with 34.9% of controls. The final Oswestry Disability Index (ODI) score was 15.0 in the vertebroplasty group and 32.1 in the conservative management group (p<0.001), and the final RDQ score was 8.1 for vertebroplasty and 10.7 for controls (p<0.001). The authors concluded that the use of percutaneous vertebroplasty for chronic compression fractures and persistent severe pain was found to be associated with greater pain relief and improved functional outcomes at 1 year as compared to conservative treatment.

Firanescu and colleagues (2018) conducted a randomized, controlled trial (VERTOS IV) to evaluate individuals requiring treatment for acute osteoporotic vertebral compression fractures. A total of 180 participants were randomised to either vertebroplasty (n=91) or a sham procedure (n=89). The study participants received local subcutaneous bupivacaine and lidocaine (lignocaine) at each pedicle. The vertebroplasty cohort also received cement, which was simulated in the sham procedure cohort. The primary outcome measure was mean reduction in visual analogue scale (VAS) scores at day 1, week 1, and 1, 3, 6, and 12 months. Clinically significant pain relief was defined as a reduction of 1.5 points in VAS scores from baseline. Secondary outcome measures were the differences between groups for alterations in the quality of life for osteoporosis and Roland-Morris disability questionnaire scores during 12 months of follow-up. The authors reported that the mean decrease in VAS score was statistically significant in both the vertebroplasty and sham-procedure groups at all follow-up points after the procedure, compared with the baseline scores. The mean difference in VAS measurement scores between the two groups was 0.20 (95% CI, -0.53 to 0.94) at baseline, -0.43 (-1.17 to 0.31) at 1 day, -0.11 (-0.85 to 0.63) at 1 week, 0.41 (-0.33 to 1.15) at 1 month, 0.21 (-0.54 to 0.96) at 3 months, 0.39 (-0.37 to 1.15) at 6 months, and 0.45 (-0.37 to 1.24) at 12 months. Changes in VAS scores were not statistically significant between the groups during 12 months of follow-up. The secondary outcomes were not statistically significant. A decrease in the use of analgesics (non-opioids, weak opioids, strong opioids) was statistically significant in both groups at all time points, with no statistically significant differences between the two cohorts. The researchers reported two adverse events in the vertebroplasty group: one respiratory insufficiency and one vasovagal reaction. The authors concluded that percutaneous vertebroplasty did not result in statistically significant pain reduction versus the sham procedure during 12 months of follow-up among individuals with acute osteoporotic vertebral compression fractures.

Lin and colleagues (2017) reported the results of a retrospective study evaluating the mortality risk of participants older than age 70 who had vertebral compression fractures and were treated with early vertebroplasty (within 3 months) or conservative therapy. A total of 10,785 individuals with painful vertebral compression fractures who used analgesic injection during admission from 2000 through 2013 were selected from the National Health Insurance Research Database in Taiwan. After matching, a total of 1773 vertebroplasty subjects and 5324 non-vertebroplasty subjects were included in this study. The authors employed the Conditional Cox proportional hazard models to determine the risk of respiratory complications and death. The researchers identified a “significant difference in survival curves of mortality and respiratory failure” between both groups of participants (p<0.05). The incidence of death at 1 year in the vertebroplasty cohort 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 cohort was 0.63 per 100 person-months (95% CI, 0.57 to 0.70). The hazard ratio between groups for respiratory failure was 1.46 (95% CI, 1.04 to 2.05; p=0.028). Limitations of this study included the broad selection of participants, which was not limited to individuals with osteoporotic lesions. Also, the database did not report on functional outcomes or pain.

Percutaneous Kyphoplasty

Percutaneous kyphoplasty is a modification of vertebroplasty and involves inflation of a balloon within the collapsed vertebral body prior to stabilization with bone cement. Initial evidence regarding efficacy of kyphoplasty includes prospective, uncontrolled and retrospective studies. Multiple prospective, uncontrolled studies (Berlemann, 2004; Coumans, 2003; Dudeney, 2002; Lieberman 2001; Phillips, 2003; Theodorou, 2002) and several retrospective studies (Ledlie, 2003; Rhyne, 2004) that evaluated kyphoplasty (total of 342 individuals) were included in early published literature. Participants in the studies were generally individuals with vertebral compression fractures resulting from osteoporosis, although other conditions were not excluded. These studies reported a degree of pain relief, improved mobility and enhanced quality of life that was similar to that reported for participants in the vertebroplasty studies, with approximately 35% restoration of vertebral body height in the majority of individuals. The largest of the prospective studies reported on 1-year clinical outcomes with a follow-up period up to 18 months. Both pain and disability scores improved significantly from preoperative to postoperative levels, and seven areas of the SF-36 inventory demonstrated significant improvement postoperatively. Early results suggested that kyphoplasty could restore some vertebral height in individuals with compression fractures.

In 2011, Boonen and colleagues studied balloon kyphoplasty as compared to non-surgical treatment for acute vertebral fractures. Adults with one to three vertebral fractures were randomized within 3 months from onset of pain to undergo kyphoplasty (n=149) or non-surgical therapy (n=151). Quality of life, function, disability, and pain were assessed over 24 months. Kyphoplasty was associated with greater improvements in SF-36 PCS scores when averaged across the 24-month follow-up period, compared with non-surgical therapy; overall treatment effect was 3.24 points, (1.47-5.01; p≤0.0004). The treatment difference remained statistically significant at 6 months at 3.39 points (1.13-5.64; p≤0.003) but not at 12 months when values were 1.70 points, (-0.59 to 3.98; p≤0.15) or at 24 months 1.68 points (-0.63 to 3.99; p≤0.15). Greater improvement in back pain was observed over 24 months for kyphoplasty overall treatment effect -1.49 points (-1.88 to -1.10; p≤0.0001); the difference between groups remained statistically significant at 24 months (-0.80 points, -1.39 to -0.20; p≤0.009). There were two device-related serious adverse events in the second year that occurred at index vertebrae (a spondylitis and an anterior cement migration). There was no statistically significant difference between groups in the number of participants (47.5% for kyphoplasty, 44.1% for control) with new radiographic vertebral fractures, and fewer fractures occurred within the second year. Compared with non-surgical management, kyphoplasty rapidly reduces pain and improves function, disability, and QOL without increasing the risk of additional vertebral fractures. The differences from non-surgical management are statistically significant when averaged across 24 months. Most outcomes are not statistically different at 24 months, but the reduction in back pain remains statistically significant at all time points.

Comparison of Percutaneous Vertebroplasty and Percutaneous Kyphoplasty

Chang and colleagues (2015) performed a large meta-analysis of prospective studies that compared the safety and efficacy of percutaneous vertebroplasty to percutaneous kyphoplasty for the treatment of osteoporotic vertebral compression fractures. A total of 6 randomized controlled trials and 14 prospective comparative studies were included consisting of 1429 subjects. Upon comparison of the two methods, the time to perform kyphoplasty was longer than vertebroplasty. There was no significant difference between the two groups in the VAS pain scores or ODI scores at short-term (no more than 1 week after the surgery) or long-term (more than 6 months) follow-up. However, vertebroplasty had a greater risk of cement leakage (although the percentage of cases of cement leakage was high for both procedures), was inferior in reducing Cobb angle in the long term, and resulted in lower anterior vertebral body height after surgery.

A 2016 randomized controlled trial by Evans and colleagues compared vertebroplasty to kyphoplasty for the treatment of vertebral compression fractures and concluded that both procedures appeared to be equally effective in reducing pain and disability in individuals with vertebral body compression fractures. A total of 115 subjects were enrolled in the study with 59 (51.3%) randomized to kyphoplasty and 56 (48.7%) randomized to vertebroplasty. Baseline demographic and clinical characteristics were similar in both groups. Mean pain scores at baseline, 3 days, 30 days, and 1 year for kyphoplasty versus vertebroplasty were 7.4 (1.9) vs 7.9 (2.0), 4.1 (2.8) vs 3.7 (3.0), 3.4 (2.5) vs 3.6 (2.9), and 3.0 (2.8) vs 2.3 (2.6), respectively (p>0.05 at all time points). Mean Roland-Morris Low Back pain and Disability Questionnaire (RMDQ) scores at baseline, 3 days, 30 days, 180 days, and 1 year were 17.3 (6.6) vs 16.3 (7.4), 11.8 (7.9) vs 10.9 (8.2), 8.6 (7.2) vs 8.8 (8.5), 7.9 (7.4) vs 7.3 (7.7), 7.5 (7.2) vs 6.7 (8.0), respectively (p>0.05 at all time points). The authors concluded that the evidence from this trial was consistent with findings from two previous randomized controlled trials (Dohm, 2014; Liu, 2010) and indicate “vertebroplasty and kyphoplasty are equally effective in reducing pain and disability related to vertebral compression fractures.”

Risk for Subsequent Fractures

There has been concern that the treatment of symptomatic vertebral fractures by either percutaneous vertebroplasty or kyphoplasty may cause subsequent vertebral fracture (Jensen, 2004; Kallmes, 2003). This concern was reinforced with biomechanical data from cadaver studies showing cement augmentation places additional stress on adjacent levels by creating reduced compliance in the treated vertebra (Baroud, 2003; Bereleman, 2002). Multiple retrospective studies (Fribourg, 2004; Syed, 2005; Trout, 2006; Uppin, 2003) suggest following either vertebroplasty or kyphoplasty, individuals are at increased risk for new adjacent level fractures.

There is, however, difficulty demonstrating a causal relationship between either vertebroplasty or kyphoplasty and subsequent spinal fracture as the natural history of osteoporotic spine fractures is not well known. Anecdotal and small case series suggest there may be both temporal and spatial clustering of untreated vertebral fractures. A large study of temporal clustering (Lindsay, 2001) retrospectively looked at 2725 women in the placebo arms of four risedronate sodium trials. The overall incidence of new vertebral fractures in the first year was 6.6%, but the presence of a vertebral fracture at baseline increased the risk of a new vertebral fracture five-fold during the initial year of the study. Spatial clustering is defined as the known propensity for spontaneous osteoporotic spinal fractures to occur in a bi-modal distribution at midthoracic (T7-T9) and thoracolumbar (T12-L1) regions. Since spinal fractures treated with either vertebroplasty or kyphoplasty are more common in these regions to begin with and the adjacent vertebrae may be inherently at increased risk for fracture with or without treatment, a higher risk of adjacent rather than distant fracture might be a result of the natural history of clustered vertebral fracture and not cement augmentation. In the absence of an adequate control group of untreated spinal fractures in these studies, it is difficult to establish a causal relationship between vertebroplasty or kyphoplasty and subsequent spinal fracture. The results suggest following either vertebroplasty or kyphoplasty, individuals are at risk of new onset adjacent fractures and when these adjacent fractures occur, they occur sooner than non-adjacent level fractures. Randomized, prospective studies comparing individuals treated with vertebroplasty or kyphoplasty to untreated controls are necessary to determine if there is a causal relationship between these procedures and subsequent spinal fracture.

Kiva® Vertebral Implant

In a prospective controlled randomized study, Korovessis and colleagues (2013) compared kyphoplasty to the Kiva vertebral implant (a variant of the vertebroplasty technique) for the treatment of osteoporotic fractures. The kyphoplasty group consisted of 86 subjects with 122 fractures, and the Kiva group consisted of 82 subjects with 133 fractures. There were no statistically significant differences in the preoperative baseline characteristics of the two groups. Postoperative follow-up evaluations averaged 14 months for all participants. The authors reported that at follow-up, both kyphoplasty and Kiva restored osteoporotic vertebral body height. Additionally, Kiva restored the body wedge deformity safely, and in a larger amount.

Subsequently, Korovessis and colleagues (2014) performed a prospective randomized controlled short-term study that compared kyphoplasty to the Kiva vertebral implant for the treatment of osteolytic metastasis to the spine. The kyphoplasty group consisted of 24 subjects with 43 osteolytic vertebral bodies and the Kiva group consisted of 23 subjects with 41 osteolytic vertebral bodies. There were no survivors after 3 months; however, both kyphoplasty and Kiva were noted to have provided equally significant pain relief with an absence of cement leakage in the Kiva group versus 4 subjects (9.3%) with absence of neurological complication in the kyphoplasty group.

Tutton and colleagues (2015) performed the KAST (Kiva Safety and Effectiveness Trial) study, a multi-center, randomized controlled trial designed to evaluate noninferiority of the Kiva system as compared to balloon kyphoplasty (BK) for the treatment of painful, osteoporotic VCFs. Three hundred individuals with one or two painful osteoporotic VCFs were randomly assigned to receive either Kiva (n=153) or BK (n=147). Treatment was blinded until just prior to the procedure. The primary endpoint was a composite at 12 months that included a reduction in pain by 15 mm or more on the VAS, improvement or maintenance in function according to the ODI, and the absence of device-related serious adverse events. Secondary endpoints included volume of cement usage, change of VAS and ODI scores from baseline, extravasation, and adjacent level fracture. A total of 253 subjects (Kiva: n=153 and BK: n=126) completed the trial through the 12-month follow-up period. Primary endpoints were met with a mean improvement of 70.8 and 71.8 points in the VAS score and 38.1 and 42.2 points in the ODI score in the Kiva and BK groups, respectively, and no device-related serious adverse events. Evaluation of secondary endpoints indicated superiority of Kiva over BK with respect to bone cement usage and extravasation measured at the immediate postoperative time point. The authors concluded that the KAST study demonstrated noninferiority in safety, effectiveness, and product performance of the Kiva as compared with BK, with superiority or a trend to superiority for several secondary outcomes.

Sacroplasty

Sacroplasty is a variation of vertebroplasty technique involving injection of polymethylmethacrylate cement into sacral fractures. A literature search focused on clinical trials of sacroplasty identified two prospective studies by the same author. Frey and colleagues (2007) reported the findings of a prospective observational cohort study which assessed the safety and efficacy of sacroplasty in 37 individuals with sacral fractures related to osteoporosis. Treatment effectiveness was based on changes in the VAS score, duration of symptoms and analgesic usage. Individuals were reported to experience an overall 50% reduction in pain prior to discharge and a sustained relief of pain for 12 months postoperatively. The investigators concluded that sacroplasty appears to be a safe and effective remedy for painful osteoporotic sacral insufficiency fractures (SIFs). In the largest prospective cohort, Frey and colleagues (2008) reported on the outcomes of 52 individuals with sacral fractures who underwent sacroplasty. Baseline VAS scores improved immediately after the procedure with durable treatment effects at 52 weeks. The authors concluded more rigorous trials are warranted to provide definitive evidence of the safety and efficacy of sacroplasty.

In a retrospective multicenter analysis, Kortman and colleagues (2013) evaluated 204 individuals with painful SIFs and 39 individuals with symptomatic sacral lesions treated with either the short-axis or long-axis sacroplasty technique. A total of 169 persons had bilateral SIFs and 65 had additional fractures of the axial skeleton. Individuals were followed up at 1-month intervals for at least 1 year. VAS scores improved from 9.2 before treatment to 1.9 after treatment in those with SIFs, and from 9.0 to 2.6 in those with sacral lesions. There was one case of radicular pain due to extravasation of cement requiring surgical decompression.

Heo and colleagues (2017) conducted a retrospective review of 68 individuals (4 men and 64 women) with sacral fractures who were followed for more than 12 months after fluoroscopically guided percutaneous sacroplasty. The etiology of the fractures was osteoporosis with minor trauma (32 cases) and osteoporotic insufficiency (36 cases). Tumor-related SIFs were not included in the analysis. Clinical parameters investigated included initial diagnosis, signs, symptoms, visual analog scale (VAS) of pain, functional mobility scale score, past history of illness, amount of bone cement infused, and complications related to sacroplasty. Radiological parameters analyzed included the pattern of SIFs, T-score cement leakage, and concomitant fractures in other sites. All participants had severe osteoporosis (mean T score: -3.9 ± 0.5). Cement leakage into the sacroiliac joint occurred in 2 subjects but there were no symptoms related to cement leakage and no reported cases of cement leakage into the neural foramen. Functional mobility scores improved from 3.82 ± 0.68 preoperatively to 1.09 ± 0.74 at the last follow-up visit. VAS scores improved from 8.65 ± 0.97 to 2.41 ± 1.07. Both functional mobility and VAS scores were significantly improved following sacroplasty and these improvements continued through the follow-up period (P<0.05).

Dmytriw and colleagues (2017) reported the findings of a case study involving an 81 year old individual with multiple myeloma who underwent percutaneous sacroplasty as a treatment for a painful sacral fracture. No immediate post-procedural complications were reported. The subject reported himself to be pain-free 1 day following the procedure, and continued to be pain-free at 2 years of follow-up. The authors concluded that sacroplasty is technically feasible and can provide durable relief of symptoms in individuals with painful pathologic fractures of the sacrum.

Frey and colleagues (2017) reported on the long-term efficacy of sacroplasty when compared to nonsurgical management of sacral insufficiency fractures. This prospective, observational cohort study spanned 10 years and was comprised of 244 individuals with sacral insufficiency fractures. A total of 210 individuals were treated with sacroplasty and 34 with nonsurgical methods. The VAS was used to measure pain prior to treatment and at several follow-up visits. The mean pretreatment VAS scores for the nonsurgical treatment group was 7.47 versus 8.29 for the sacroplasty group. Both forms of treatment led to a significant improvement in the VAS from pretreatment scores to the VAS measurements at 2-year follow-up (p<0.001). However, the sacroplasty treatment group demonstrated significant VAS score improvement during the follow-up points (pretreatment to post [p<0.001]; posttreatment through 2 weeks [p>0.001]; 12 weeks through 24 weeks [p=0.014]; 24 weeks through 1 year [p=0.002]). Meanwhile, the nonsurgical treatment group experienced only one significant pain improvement score at the 2-week follow-up posttreatment (p=0.002). The authors acknowledge that a major limitation of this study was that participants in the nonsurgical treatment arm were only followed through 2 years and were not contacted at the 10-year follow-up.

Other Considerations

In 2010, the American Academy of Orthopaedic Surgeons’ Board of Directors issued a clinical practice guideline on the treatment of osteoporotic spinal compression fractures. A strong recommendation was made “against vertebroplasty for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact.” These recommendations were based on a literature review through September 2009 and published trials after that time were not included in their review.

The American College of Radiology (ACR) updated their appropriateness criteria on the management of osteoporotic vertebral compression fractures in 2014 (McConnell and colleagues). A summary of information provided by the ACR includes the following:

The American College of Radiology (ACR), the American Society of Neuroradiology (ASNR), the Society of Neurointerventional Surgery (SNIS), the American Society of Spine Radiology (ASSR), and the Society of Interventional Radiology (SIR) Practice Parameter for the Performance of Vertebral Augmentation (2017) addresses the following indications for vertebroplasty and kyphoplasty:

The major indication for vertebral augmentation is the treatment of symptomatic osteoporotic vertebral body fracture(s) refractory to medical therapy or vertebral bodies weakened due to neoplasia. Currently, there is a lack of conclusive evidence to support the use of prophylactic vertebral augmentation to prevent future osteoporotic fracture. The indications and contraindications for vertebral augmentation may change in the future as more research and information become available.

A joint position statement on percutaneous vertebral augmentation (Barr, 2014) was developed by multiple professional societies including SIR, ACR, ASNR, ASSR, and includes the following:

It is the position of the Societies that percutaneous vertebral augmentation (PVA) 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 a manner in accordance with published standards. These procedures are offered only when non operative medical therapy has not provided adequate pain relief or pain is significantly altering the patient’s quality of life.

Conclusions

Both vertebroplasty and kyphoplasty have emerged as accepted treatment options for certain vertebral lesions that have not responded to conservative therapy. However, individuals who undergo either procedure should be informed of treatment risks including subsequent spinal fracture. Additionally, there is insufficient evidence available in the peer reviewed medical literature to support the use of percutaneous vertebroplasty or kyphoplasty for the treatment of acute fractures.

There is insufficient evidence available in the peer-reviewed medical literature to allow for adequate evaluation of sacroplasty. Small numbers of individuals treated without the use of controls leaves uncertainty regarding the impact of sacroplasty on health outcomes.

Background/Overview

Percutaneous vertebroplasty is an interventional treatment for pain. The procedure involves the radiologically guided injection of bone cement into an osteolytic or osteoporotic vertebral body compression fracture. It has been used in all levels of the vertebrae (cervical, thoracic, lumbar and sacral) and is usually performed under local anesthesia combined with sedation. Procedural complications are most often related to leakage of the cement. The goal of vertebroplasty is relieving pain, improving mobility, and preventing further collapse of the vertebrae. The technique has been performed in individuals with osteolytic vertebral metastases, myeloma, or plasmacytoma, and also as a therapy for vertebral collapse or vertebral compression fracture related to osteoporosis, or as a treatment of a painful vertebral hemangioma. Spinal compression fractures are a common problem with osteoporosis, especially for women over the age of 50, and are also fairly common in men over the age of 50. These fractures may cause persistent pain, deformation, and the potential loss of sensation, mobility and continence.

Percutaneous kyphoplasty combines vertebroplasty with a preliminary step to attempt to restore vertebral height using an inflatable bone tamp. A small incision is made in the skin creating a path to the fractured vertebra, after which an inflatable bone tamp is placed in the channel. When inflated, under x-ray image guidance, the bone tamp compacts the surrounding bone and pushes the collapsed bone back up toward its normal position. A cavity is created which, after balloon removal, can be filled with liquid bone cement creating a permanent, internal cast. The risk of cement leakage is theoretically reduced because inflation of the balloon creates a void within the vertebral body into which cement can be injected under relatively low pressure.

The mechanism of action of vertebroplasty or kyphoplasty is unknown; necrosis of tumor or destruction of nerve endings in adjacent healthy tissue may be caused by mechanical, vascular, chemical and or thermal changes due to heat produced during cement hardening. Mechanical stabilization of bone is another possible treatment effect.

The Kiva VCF Treatment System is an implanted device that received 510K marketing clearance from the FDA in January 2014. It involves a variant of the vertebroplasty technique and is intended to result in endplate re-elevation and fracture reduction. After vertebral displacement by the implant, the device is filled with bone cement.

Sacroplasty (a variation of the vertebroplasty technique) involves the use of CT or fluoroscopic guidance to inject polymethylmethacrylate cement into the sacral fracture(s). This procedure is being investigated as an alternative treatment in those with sacral insufficiency fractures (SIF) related to osteoporosis. Sacral insufficiency fractures as a result of osteoporosis may produce pain in the low back, hip, buttock or groin. Standard treatment for SIF includes bed rest, limited weight-bearing activities, oral analgesics, and sacral corsets. Improvement of symptoms may take as long as 12 months.

Definitions

Kyphosis: Curvature of the spine producing convexity or arching of the back.

Osteolytic: Causing dissolution of bone; applied especially to the removal or loss of the calcium of bone.

Osteoporosis: Loss of normal bone density, mass and strength, leading to increased porousness and vulnerability to fracture.

Osteoporotic: Pertaining to or characterized by osteoporosis.

Percutaneous: Through the skin (puncture as opposed to "open" surgical incision).

Plasmacytoma: A form of cancer that may turn into myeloma. It begins in plasma cells (white blood cells that produce antibodies).

Spine Anatomy: The spine is divided into three major sections: the cervical (neck), the thoracic (mid-back) and lumbar spine (lower back); these sections are made up of individual bones called vertebrae, which are the primary area of weight bearing and provide a resting-place for the discs, which act as shock absorbers between the vertebrae.

Vertebral augmentation: A general term which is used to refer to any one of several percutaneous techniques used to attain internal vertebral body stabilization. Some of the more commonly used vertebral augmentation procedures include, but are not limited to vertebroplasty and kyphoplasty.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

CPT

 

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 [when specified as lumbar]

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 [when specified as other than sacral]

22513

Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; thoracic

22514

Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; lumbar

22515

Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; each additional thoracic or lumbar vertebral body

 

 

HCPCS

 

S2360

Percutaneous vertebroplasty, one vertebral body, unilateral or bilateral injection; cervical

S2361

Percutaneous vertebroplasty, one vertebral body, unilateral or bilateral injection; each additional cervical vertebral body

 

 

ICD-10 Procedure

 

0PU33JZ

Supplement cervical vertebra with synthetic substitute, percutaneous approach

0PU34JZ

Supplement cervical vertebra with synthetic substitute, percutaneous endoscopic approach

0PU43JZ

Supplement thoracic vertebra with synthetic substitute, percutaneous approach

0PU44JZ

Supplement thoracic vertebra with synthetic substitute, percutaneous endoscopic approach

0QU03JZ

Supplement lumbar vertebra with synthetic substitute, percutaneous approach

0QU04JZ

Supplement lumbar vertebra with synthetic substitute, percutaneous endoscopic approach

 

 

ICD-10 Diagnosis

 

 

All diagnoses

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above, when criteria are not met; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.
 

When services are also Investigational and Not Medically Necessary:

CPT

 

22511

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

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 [when specified as sacral]

0200T

Percutaneous sacral augmentation (sacroplasty), unilateral injection(s), including the use of a balloon or mechanical device, when used, 1 or more needles, includes imaging guidance and bone biopsy, when performed

0201T

Percutaneous sacral augmentation (sacroplasty), bilateral injections, including the use of a balloon or mechanical device, when used, 2 or more needles, includes imaging guidance and bone biopsy, when performed

 

 

ICD-10 Procedure

 

0QU13JZ

Supplement sacrum with synthetic substitute, percutaneous approach

0QU14JZ

Supplement sacrum with synthetic substitute, percutaneous endoscopic approach

0QUS3JZ

Supplement coccyx with synthetic substitute, percutaneous approach

0QUS4JZ

Supplement coccyx with synthetic substitute, percutaneous endoscopic approach

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Amar AP, Larsen DW, Esnaashari N, et al. Percutaneous transpedicular polymethylmethacrylate vertebroplasty for the treatment of spinal compression fracture. Neurosurgery. 2001; 49(5):1105-1115.
  2. Baroud G, Nemes J, Heini P, Steffen T. Load shift of the intervertebral disc after a vertebroplasty: a finite-element study. Eur Spine J. 2003; 12(4):421-426.
  3. Berenson J, Pflugmacher R, Jarzem P, et al. Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomized controlled trial. Lancet Oncol. 2011; 12(3):225-235.
  4. Berlemann U, Ferguson SJ, Nolte LP, Heini PF. Adjacent vertebral failure after vertebroplasty. A biomechanical investigation. J Bone Joint Surg Br. 2002; 84(5):748-752.
  5. Berlemann U, Franz T, Orler R, Heini PF. Kyphoplasty for treatment of osteoporotic vertebral fractures: a prospective nonrandomized study. Eur Spine J. 2004; 13(6):496-501.
  6. Blasco J, Martinez-Ferrer A, Macho J, et al. Effect of vertebroplasty on pain relief, quality of life, and the incidence of new vertebral fractures: a 12-month randomized follow-up, controlled trial. J Bone Miner Res. 2012; 27(5):1159-1166.
  7. Bono CM, Heggeness M, Mick C, et al. North American Spine Society: Newly released vertebroplasty randomized controlled trials: a tale of two trials. Spine J. 2010; 10(3):238-240.
  8. Boonen S, Van Meirhaeghe J, Bastian L, et al. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. J Bone Miner Res. 2011; 6(26):1627-1637.
  9. Brown DB, Golula LA, Sehgal M, Shimony JS. Treatment of chronic symptomatic vertebral compression fractures with percutaneous vertebroplasty. AJR Am J Roentgenol. 2004; 182(2):319-322.
  10. Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009; 361(6):557-568.
  11. Chang X, Lv YF, Chen B, et al. Vertebroplasty versus kyphoplasty in osteoporotic vertebral compression fracture: a meta-analysis of prospective comparative studies. Int Orthop. 2015; 39(3):491-500.
  12. Chen D, An ZQ, Song S, et al. Percutaneous vertebroplasty compared with conservative treatment in patients with chronic painful osteoporotic spinal fractures. J Clin Neurosci. Mar 2014; 21(3):473-477.
  13. Chew C, Craig L, Edwards R et al. Safety and efficacy of percutaneous vertebroplasty in malignancy: a systematic review. Clin Radiol. 2011; 66(1):63-72.
  14. Coumans JV, Reinhardt MK, Lieberman IH. Kyphoplasty for vertebral compression fractures: 1-year clinical outcomes from a prospective study. J Neurosurg. 2003; 99(1 Suppl):44-50.
  15. Dmytriw AA, Talla K, Smith R. Percutaneous sacroplasty for the management of painful pathologic fracture in a multiple myeloma patient: Case report and review of the literature. Neuroradiol J. 2017; 30(1):80-83.
  16. Dohm M, Black CM, Dacre A, et al; KAVIAR investigators. A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures due to osteoporosis. AJNR Am J Neuroradiol. 2014; 35(12):2227-2236.
  17. Dudeney S, Lieberman IH, Reinhardt MK, Hussein M. Kyphoplasty in the treatment of osteolytic vertebral compression fractures as a result of multiple myeloma. J Clin Oncol. 2002; 20(9):2382-2387.
  18. Evans AJ, Kip KE, Brinjikji W, et al. Randomized controlled trial of vertebroplasty versus kyphoplasty in the treatment of vertebral compression fractures. J Neurointerv Surg. 2016; 8(7):756-763.
  19. Firanescu CE, de Vries J, Lodder P, et al. Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomized sham controlled clinical trial. BMJ. 2018; 361:k1551.
  20. Frey ME, DePalma MJ, Cifu DX, et al. Efficacy and safety of percutaneous sacroplasty for painful osteoporotic sacral insufficiency fractures. Spine (Phila Pa 1976). 2007; 32(15):1635-1640.
  21. Frey ME, Depalma MJ, Cifu DX, et al. Percutaneous sacroplasty for osteoporotic sacral insufficiency fractures: a prospective, multicenter, observational pilot study. Spine J. 2008; 8(2):367-373.
  22. Frey ME, Warner C, Thomas SM, et al. Sacroplasty: a ten-year analysis of prospective patients treated with percutaneous sacroplasty: literature review and technical considerations. Pain Physician. 2017; 20(7):E1063-E1072.
  23. Fribourg D, Tang C, Sra P, et al. Incidence of subsequent vertebral fracture after kyphoplasty. Spine (Phila Pa 1976). 2004; 29(20):2270-2276.
  24. Heo DH, Park CK. Percutaneous sacroplasty for non-neoplastic osteoporotic sacral insufficiency fractures. Pain Physician. 2017; 20(2):89-94.
  25. Jensen ME, Kallmes DF. Does filling the crack break more of the back? AJNR Am J Neuroradiol. 2004; 25(2):166-167.
  26. Kallmes DF, Comstock BA, Heagerty PJ, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Eng J Med. 2009; 361(6):569-579.
  27. Kallmes DF, Jensen ME.  Percutaneous vertebroplasty. Radiology. 2003; 229(1):27-36.
  28. Kaufmann TJ, Jensen ME, Schweickert PA, et al. Age of fracture and clinical outcomes of percutaneous vertebroplasty. AJNR Am J Neuroradiol. 2001; 22:1860-1863.
  29. Kim AK, Jensen ME, Dion JE, et al. Unilateral transpedicular percutaneous vertebroplasty: initial experience. Radiology. 2002; 222(3):737-741.
  30. 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. 2010a; 376(9746):1085-1092.
  31. Klazen CA, Venmans A, de Vries J, et al. Percutaneous vertebroplasty is not a risk factor for new osteoporotic compression fractures: results from VERTOS II. AJNR Am J Neuroradiol. 2010b; 31(8):1447-1450.
  32. Knavel EM, Thielen KR, Kallmes DF. Vertebroplasty for the treatment of traumatic nonosteoporotic compression fractures. AJNR Am J Neuroradiol. 2009; 30(2):323-327.
  33. Korovessis P, Vardakastanis K, Vitsas V, Syrimpeis V. Is Kiva implant advantageous to balloon kyphoplasty in treating osteolytic metastasis to the spine? Comparison of 2 percutaneous minimal invasive spine techniques: a prospective randomized controlled short-term study. Spine (Phila Pa 1976). 2014; 39(4):E231-E239.
  34. Korovessis P, Vardakastanis K, Repantis T, Vitsas V. Balloon kyphoplasty versus KIVA vertebral augmentation--comparison of 2 techniques for osteoporotic vertebral body fractures: a prospective randomized study. Spine (Phila Pa 1976). 2013; 38(4):292-299.
  35. 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. 2013; 5(5):461-466.
  36. 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.
  37. Ledlie JT, Renfro M. Balloon kyphoplasty: one-year outcomes in vertebral body height restoration, chronic pain, and activity levels. J Neurosurg. 2003; 98(1 suppl):36-42.
  38. Lieberman I, Reinhardt MK. Vertebroplasty and kyphoplasty for osteolytic vertebral collapse. Clin Orthop. 2003; (415 Suppl):S176-186.
  39. Lieberman IH, Dudeney S, Reinhardt K, Bell G. Initial outcome and efficacy of kyphoplasty in the treatment of painful osteoporotic vertebral compression fractures. Spine (Phila Pa 1976). 2001; 26(14):1631-1638.
  40. 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. 2017; 17(9):1310-1318.
  41. Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following a fracture. JAMA. 2001; 285(3):320-323.
  42. Liu JT, Liao WJ, Tan WC, et al. Balloon kyphoplasty versus vertebroplasty for treatment of osteoporotic vertebral compression fracture: a prospective, comparative, and randomized clinical study. Osteoporos Int. 2010; 21(2):359-364.
  43. Mathis JM, Ortiz AO, Zoarski GH. Vertebroplasty versus kyphoplasty: a comparison and contrast. AJNR Am J Neuroradiol. 2004; 25(5):840-845.
  44. McGraw JK, Lippert JA, Minkus KD, et al. Prospective evaluation of pain relief in 100 patients undergoing percutaneous vertebroplasty: results and follow-up. J Vasc Interv Radiol. 2002; 13(9):883-886.
  45. Mesfin A, Buchowski JM, Gokaslan ZL, Bird JE. Management of metastatic cervical spine tumors. J Am Acad Orthop Surg. 2015; 23(1):38-46.
  46. Peh W, Gilula LA, Peck DD. Percutaneous vertebroplasty for severe osteoporotic vertebral body compression fractures. Radiology. 2002; 223(1):121-126.
  47. Phillips FM. Minimally invasive treatments of osteoporotic vertebral compression fractures. Spine (Phila Pa 1976. 2003; 28(15 Suppl):S45-53.
  48. Ramos L, de Las Heras JA, Sánchez S, et al. Medium-term results of percutaneous vertebroplasty in multiple myeloma. Eur J Haematol. 2006; 77(1):7-13.
  49. Rhyne A 3rd, Banit D, Laxer E, et al. Kyphoplasty: report of eighty-two thoracolumbar osteoporotic vertebral fractures. J Orthop Trauma. 2004; 18(5):294-299.
  50. Stallmeyer MJ, Zoarski GH, Obuchowski AM. Optimizing patient selection in percutaneous vertebroplasty. J Vasc Interv Radiol. 2003; 14(6):683-696.
  51. Syed MI, Patel NA, Jan S, et al. New symptomatic vertebral compression fractures within a year following vertebroplasty in osteoporotic women. AJNR Am J Neuroradiol. 2005; 26(6):1601-1604.
  52. Theodorou DJ, Theodorou SJ, Duncan TD, et al. Percutaneous balloon kyphoplasty for the correction of spinal deformity in painful vertebral body compression fractures. Clin Imaging 2002; 26:1.
  53. Trout AT, Kallmes DF, Gray LA, et al. Evaluation of vertebroplasty with a validated outcome measure: the Roland-Morris Disability Questionnaire. AJNR Am J Neuroradiol. 2005; 26(10):2652-2657.
  54. Trout AT, Kallmes DF, Kaufmann TJ.  New fractures after vertebroplasty: adjacent fractures occur significantly sooner. AJNR Am J Neuroradiol. 2006; 27(1):217-223.
  55. Tutton SM, Pflugmacher R, Davidian M, et al. KAST Study: The Kiva system as a vertebral augmentation treatment-a safety and effectiveness trial: A randomized, noninferiority trial comparing the Kiva system with balloon kyphoplasty in treatment of osteoporotic vertebral compression fractures. Spine (Phila Pa 1976). 2015; 40(12):865-875.
  56. Uppin AA, Hirsch JA, Centenera LV, et al. Occurrence of new vertebral body fracture after percutaneous vertebroplasty in patients with osteoporosis. Radiology. 2003; 26(1):119-124.
  57. Vasconcelos C, Gailloud P, Beauchamp NJ, et al. Is percutaneous vertebroplasty without pretreatment venography safe? Evaluation of 205 consecutive procedures. AJNR Am J Neuroradiol. 2002; 23(6):913-917.
  58. Venmans A, Klazen CA, Lohle PN, et al. Percutaneous vertebroplasty and pulmonary cement embolism: results from VERTOS II. AJNR Am J Neuroradiol. 2010; 31(8):1451-1453.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Academy of Orthopaedic Surgeons (AAOS). Clinical Practice Guideline Treatment of osteoporotic spinal compression fractures. 2010. Available at: http://www.aaos.org/Research/guidelines/SCFguideline.pdf. Accessed on August 6, 2018.
  2. American College of Radiology (ACR), American Society of Neuroradiology (ASNR), Society of Neurointerventional Surgery (SNIS), American Society of Spine Radiology (ASSR), Society of Interventional Radiology (SIR). Practice Parameter for the performance of vertebral augmentation. 2017. Available at: https://www.acr.org/-/media/ACR/Files/Practice-Parameters/VerebralAug.pdf. Accessed on August 6, 2018.
  3. Barr JD, Jensen ME, Hirsch JA, et al; Position statement on percutaneous vertebral augmentation: a consensus statement developed by the Society of Interventional Radiology (SIR), American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), American College of Radiology (ACR), American Society of Neuroradiology (ASNR), American Society of Spine Radiology (ASSR), Canadian Interventional Radiology Association (CIRA),  and the Society of NeuroInterventional Surgery (SNIS). J Vasc Interv Radiol. 2014; 25(2):171-181.
  4. Jensen ME, McGraw JK, Cardella JF, Hirsch JA. Position Statement on Percutaneous Vertebral Augmentation: A Consensus Statement Developed by 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. J Vasc Interv Radiol. 2007; 18:325-330.
  5. McConnell CT Jr, Wippold FJ 2nd, Ray CE Jr. ACR appropriateness criteria management of vertebral compression fractures. J Am Coll Radiol. 2014; 11(8):757-763.
Websites for Additional Information
  1. National Osteoporosis Foundation (NOF). Available at: http://www.nof.org/. Accessed on: August 6, 2018.
Index

Kiva VCF Treatment System
Kyphoplasty, Percutaneous
KyphX® Inflatable Bone Tamp
Sacroplasty, Percutaneous
Vertebroplasty, Percutaneous

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Reviewed

09/13/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. Updated the Rationale, Definitions, References and Websites for Additional Information sections.

Reviewed

11/02/2017

MPTAC review. The document header wording was updated from “Current Effective Date” to “Publish Date.” Updated Description/Scope, References and History sections.

Reviewed

02/02/2017

MPTAC review. Rationale and References sections updated.

Reviewed

02/04/2016

MPTAC review. Rationale and Reference sections updated. Removed ICD-9 codes from Coding section.

Revised

02/05/2015

MPTAC review. Medically necessary statement clarified with the addition of osteoporotic vertebral compression fracture. Description, Rationale, Background and Index sections updated.

 

01/01/2015

Updated Coding section with 01/01/2015 CPT changes; removed codes 22520, 22521, 22522, 22523, 22524, 22525, 72291, 72292 deleted 12/31/2014.

Revised

02/13/2014

MPTAC review. Medically necessary statement for osteolytic vertebral metastasis updated with the addition of plasmacytoma, and the requirement for chemotherapy and radiation therapy revised to chemotherapy or radiation therapy. Description, Rationale, Background, Definition and Reference sections updated.

Reviewed

02/14/2013

MPTAC review. Title of document, Description, Rationale and Reference sections updated.

Reviewed

02/16/2012

MPTAC review. Rationale and References updated.

Revised

11/17/2011

MPTAC review. Medically necessary criteria revised to address steroid induced vertebral fracture with osteoporotic vertebral collapse criteria and delete traumatic vertebral fracture.  Updated Coding section with 01/01/2012 CPT descriptor changes.

Reviewed

08/18/2011

MPTAC review. Rationale and References updated.

Revised

08/19/2010

MPTAC review. Osteolytic vertebral metastasis medically necessary criteria statement amended to state “including myeloma.” Rationale and References updated.

Reviewed

05/13/2010

MPTAC review. Rationale and References updated.

 

01/01/2010

Updated Coding section with 01/01/2010 CPT changes.

Reviewed

05/21/2009

MPTAC review. Rationale and references updated.  Updated Coding section with 07/01/2009 CPT changes.

 

10/01/2008

Updated Coding section with 10/01/2008 ICD-9 changes.

Revised

05/15/2008

MPTAC review.  Changed title to “Percutaneous Spinal Procedures, (Vertebroplasty, Kyphoplasty and Sacroplasty). Revised stance to address sacroplasty as investigational and not medically necessary.  Clarified language in criteria to distinguish the cervical, thoracic and lumbar areas from the sacral area. Updated review date, Rationale, Coding and References.

 

02/21/2008

The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.

Reviewed

05/17/2007

MPTAC review.  Updated References and review date.

 

01/01/2007

Updated Coding section with 01/01/2007 CPT/HCPCS changes; removed CPT 76012, 76013 deleted 12/31/2006, and HCPCS S2362, S2363 deleted 03/31/2006.

Reviewed

06/09/2006

MPTAC review.  Rationale and References updated.

 

01/01/2006

Updated Coding section with 01/01/2006 CPT/HCPCS changes

Revised

07/14/2005

MPTAC review.  Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.

Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

07/27/2004

SURG.00052

Chronic Spine Pain Treatments/Procedures (Minimally Invasive)

WellPoint Health Networks, Inc.

12/02/2004

3.07.14

Percutaneous Vertebroplasty and Kyphoplasty