Percutaneous vertebroplasty (PV), percutaneous kyphoplasty, and percutaneous sacroplasty are interventional radiology procedures which involve the injection of bone cement into vertebral body compression fractures with the goal of relieving pain, improving mobility, and preventing further collapse of the bone. The procedure has been used for the treatment of osteoporotic compression fractures, painful vertebral hemangiomas, myeloma, and metastatic lesions. This document addresses percutaneous vertebroplasty, percutaneous kyphoplasty and percutaneous sacroplasty.

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:

• Osteolytic vertebral metastasis including myeloma with severe back pain related to destruction of the vertebral body not involving the major part of the cortical bone, and chemotherapy and radiation therapy have failed to relieve symptoms; or
• Vertebral hemangiomas with aggressive clinical signs (severe pain or nerve compression) or aggressive radiological signs, and radiation therapy has failed to relieve symptoms; or
• Osteoporotic vertebral collapse or steroid induced vertebral fracture with persistent debilitating pain which has not responded to accepted standard medical therapy as documented in the medical records. Standard medical therapy may include initial bed rest with progressive activity, analgesics, physical therapy, bracing and exercises to correct postural deformity and increase muscle tone, salmon calcitonin, bisphosphonates and calcium supplementation; or
• Painful vertebral eosinophilic granuloma with spinal instability.

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. 

Cervical, Lumbar, Thoracic Vertebroplasty or Kyphoplasty
Evidence regarding efficacy of percutaneous vertebroplasty (PV) comes from a number of prospective, uncontrolled trials, case series reports, and several retrospective studies.  Two large case series (total of 421 participants) indicated percutaneous vertebroplasty (PV) was highly effective in significantly reducing pain and increasing mobility in over 70% of individuals with vertebral body lesions with minimal complications (Deramond, 1998; Gangi, 1999). Additionally, a number of smaller prospective, uncontrolled studies and several retrospective studies (total of 564 participants) all reported that PV significantly reduced pain and improved mobility in the majority of participants, with few individuals experiencing persistent mild pain (Amar, 2001; Brown, 2004; Kaufmann, 2001; Kim, 2002; McGraw, 2002; Vasconcelos, 2002). Results from the majority of these studies indicate PV can produce significant pain relief, increase mobility, and improve quality of life in 70% to 80% of individuals with osteolytic lesions from hemangiomas, metastases or myeloma, or osteoporotic compression fractures. In these studies, 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.

Percutaneous kyphoplasty is a modification of vertebroplasty and involves inflation of a balloon within the collapsed vertebral body prior to stabilization with bone cement.  Evidence regarding efficacy comes from a number of prospective, uncontrolled studies and two retrospective studies.  Six prospective, uncontrolled studies (Berlemann, 2004; Coumans, 2003; Dudeney, 2002; Lieberman 2001; Phillips, 2003; Theodorou, 2002) and two retrospective studies (Ledlie, 2003; Rhyne, 2004) that evaluated kyphoplasty (total of 342 individuals) were identified in the literature.  Participants included in the studies were generally those with vertebral compression fractures resulting from osteoporosis, although those with 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 suggest that kyphoplasty can restore some vertebral height in individuals with compression fractures.

Since the first North American case series of vertebroplasty appeared in the literature (Deramond, 1998), there has been concern that the treatment of symptomatic vertebral fractures by either percutaneous vertebroplasty or kyphoplasty may cause subsequent vertebral fracture (Grados, 2000; 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). More recent 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. The largest 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 mid thoracic (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 (Fribourg, 2004; Syed, 2005; Trout, 2006; Uppin, 2003), 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. 

In 2009, the Practice Guideline for the Performance of Vertebroplasty was revised collaboratively by 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) and states:

Vertebroplasty is an established, safe, and effective procedure for selected patients. Extensive experience documents its safety and efficacy. As with any invasive procedure, the patient is most likely to benefit when the procedure is performed in an appropriate environment by qualified physicians…

Two multi center randomized, placebo controlled trials were published, focusing on individuals with osteoporotic fracture.

Buchbinder (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; both groups reported significant reductions in pain. 

Kallmes (2009) published 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 one month assessment, there was no significant difference between the two groups; both groups had similar improvements in pain and disability.  After this initial assessment, individuals were allowed to cross over to the alternate treatment; by three months 8 individuals (12%) in the PV 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 issued a commentary on the studies in October 2009. In their publication, NASS stated:

The intent of this analysis is not to in any way defame the studies or question the integrity of the authors. Instead, it is to perhaps help explore why there is such a seeming disconnect between the conclusions of these two PRCTs and previous experience and data. Without being overly critical and judgmental, there are a number of key factors that should be noticed. . . .Like any attempt at comparing two treatments in a systematic and controlled manner, there are inevitably biases and factors that can favor one treatment over another. However, there is no such thing as an infallible PRCT. That being said, any group who undertakes such a task should be praised.

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 for a multicenter (6) prospective randomized trial. 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 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 (PV) 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. Two hundred two 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 less than 0.0001) at 1 month and 2.0 (1.13-2.80, p less than 0.0001) at 1 year. No serious complications or adverse events were reported.

In the same group (above) Klazen and colleagues (2010b) further studied the possibility of new vertebral compression fractures (VCF) after vertebroplasty. Incidence, distribution, and timing of new VCFs during follow-up were assessed from spine radiographs as well as further height loss was measured of treated vertebral fractures. 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 = .44). There was no higher fracture risk for adjacent-versus-distant vertebrae. Mean time to new VCF was 16.2 months after PV and 17.8 months after conservative treatment. The baseline number of VCFs was the only risk factor for occurrence (OR, 1.43; 95% CI, 1.05-1.95) and number (p = .01) of new VCFs. After conservative therapy, further height loss of treated vertebrae occurred more frequently (35 of 85 versus 11 of 91 subjects, p less than .001) and was more severe (p less than .001) than after PV.

Incidence of new VCFs was not different after PV compared with conservative therapy after a mean of 11.4 months' follow-up. The only risk factor for new VCFs was the number of VCFs at baseline. PV contributed to preservation of stature by decreasing both the incidence and severity of further height loss in treated vertebrae.

Boonen and colleagues (2011) studied balloon kyphoplasty 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 less than or equal to 0.0004). The treatment difference remained statistically significant at 6 months at 3.39 points (1.13-5.64; p less than or equal to 0.003) but not at 12 months when values were 1.70 points, (-0.59 to 3.98; p less than or equal to 0.15) or at 24 months 1.68 points (-0.63 to 3.99; p less than or equal to 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 less than or equal to 0.0001); the difference between groups remained statistically significant at 24 months (-0.80 points, -1.39 to -0.20; p less than or equal to 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.

Summary
Given the subjective outcome of pain, a placebo effect is expected with both vertebroplasty and kyphoplasty.  Therefore, a placebo-controlled randomized controlled trial would ideally confirm that the treatment effect surpasses the placebo effect.  Although such a study has not been done, the reported case series from multiple different institutions have consistently reported statistically significant reductions in pain compared to baseline.  When long term results are reported, the treatment effect appears to be durable.  Based on this data, both kyphoplasty and vertebroplasty have emerged as an accepted option for those with vertebral lesions that have not responded to conservative therapy.  However, individuals who undergo either procedure should be informed of a significant risk of subsequent spinal fracture.  Whether this risk is greater than the natural history of the treated condition as a result of the procedure is not known.

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 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 a visual analogue scale (VAS), 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. In a 2008 study, Frey 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.

Percutaneous vertebroplasty is an interventional procedure involving the radiologically guided injection of bone cement into an osteolytic or osteoporotic vertebral body compression fracture.  The technique has been used in all levels of the vertebrae, i.e., cervical, thoracic, lumbar and sacral (sacroplasty).  The procedure is usually performed under local anesthesia combined with sedation and may be performed on an outpatient basis or may require a short hospital stay.  Procedural complications are relatively rare and most that do occur are related to leakage of the cement.  The goal of PV is relieving pain, improving mobility, and preventing further collapse of the bone.  The technique has been performed in individuals with osteolytic metastases, frequently those associated with multiple myeloma, and also as a therapy for vertebral collapse related to osteoporosis, or as a treatment of a painful vertebral hemangioma.  Spinal compression fractures are a common problem with osteoporosis and occur in more than 25% of women 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.

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.   

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).

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.

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:

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:

Future ICD-10 coding (effective 10/01/2013)
A draft of ICD-10 Coding related to this document, as it might look today, is available for reference and comments at: Appendix 1: Future ICD-10 coding

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; 49:1105-1115.
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. 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):
7. Brown DB, Golula LA, Sehgal M, Shimony JS.  Treatment of chronic symptomatic vertebral compression fractures with percutaneous vertebroplasty.  Am J Roentgenol. 2004; 182:319-322.
8. 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.
9. Coumans JV, Reinhardt MK, Lieberman IH. Kyphoplasty for vertebral compression fractures: 1-year clinical outcomes from a prospective study. J Neurosurg. 2003; 99(1 Supple):44-50.
10. Deen HG, Fenton DS, Lamer TJ. Minimally invasive procedures for disorders of the lumbar spine. Mayo Clin Proc. 2003; 78(10):1249-1256.
11. Deramond H, Depriester C, Galibert P, et al. Percutaneous vertebroplasty with polymethyl-methacrylate: technique, indications, and results. Radio Clin North Am. 1998; 36(3):533-546.
12. Do HM. Percutaneous vertebroplasty: rationale, clinical outcomes, and future directions. Neuroimaging Clin N Am. 2003; 13(2):343-363.
13. Dudeney S, Lierberman IH, Reinhardt MK, Hussein M. Kyphoplasty in the treatment of osteolytic vertebral compression fractures as a result of multiple myeloma. Journal of Clinical Oncology 2002; 20(9):2382-2387.
14. Frey ME, DePalma MJ, Cifu DX, et al. Efficacy and safety of percutaneous sacroplasty for painful osteoporotic sacral insufficiency fractures. Spine. 2007; 32(15):1635-1640.
15. Frey ME, Depalma MJ, Cifu DX, et al. Percutaneous sacroplasty for osteoporotic sacral insufficiency fractures: a prospective, multicenter, observational pilot study. Spine J. 2008; 8:367-373.
16. Fribourg D, Tang C, Sra P, et al. Incidence of subsequent vertebral fracture after kyphoplasty. Spine. 2004; 29(20):2270-2276.
17. Gangi A, Dietemann JL, Guth S, et al. Computed tomography (CT) and fluoroscopy-guided vertebroplasty: results and complications in 187 patients. Semin Interv Radiol. 1999; 16:137-142.
18. Garfin SR, Yuan HA, Reilly MA. Kyphoplasty and vertebroplasty for the treatment of painful osteoporotic compression fractures. Spine 2001; 14:1511-1515.
19. Jensen ME, Kallmes DF.  Does filling the crack break more of the back? AJNR Am J Neuroradiol. 2004; 25(2):166-167.
20. Kallmes DF, Comstock BA, Heagerty PJ, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Eng J Med 2009; 361:569-579.
21. Kallmes DF, Jensen ME.  Percutaneous vertebroplasty. Radiology. 2003; 229(1):27-36.
22. 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.
23. Kim AK, Jensen ME, Dion JE, et al. Unilateral transpedicular percutaneous vertebroplasty: initial experience. Radiology. 2002; 222(3):737-741.
24. Klazen CA, Lohle PN, de Vries J, Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010a; 376(9746):1085-1092. 
25. 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. Am J Neuroradiol. 2010b; 31(8):1447-1450.
26. Lane JM, Johnson CE, Safdar BA, et al. Minimally invasive options for the treatment of osteoporotic vertebral compression fractures. Orthop Clin N Am. 33:2002; 431-438.
27. Ledlie JT, Renfro M. Balloon kyphoplasty: one-year outcomes in vertebral body height restoration, chronic pain, and activity levels. J Neurosurg (Spine 1). 2003; 98:36-42.
28. Lieberman I, Reinhardt MK. Vertebroplasty and kyphoplasty for osteolytic vertebral collapse. Clin Orthop. 2003; (415 Suppl):S176-186.
29. Lieberman IH, Dudeney S, Reinhardt K.  Initial outcome and efficacy of kyphoplasty in the treatment of painful osteoporotic vertebral compression fractures.  Spine 2001; 26:1831-1838.
30. 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.
31. Mathis JM, Ortiz AO, Zoarski GH. Vertebroplasty versus kyphoplasty: a comparison and contrast. AJNR Am J Neuroradiol. 2004; 25(5):840-845.
32. 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.
33. Peh W et al. Percutaneous vertebroplasty for severe osteoporotic vertebral body compression fractures. Radiology 2002; 223:121-126.
34. Phillips, FM.  Minimally invasive treatments of osteoporotic vertebral compression fractures.  Spine. 2003; 28(15):S45-53.
35. Rhyne A, Banit D, Laxer E, et al. Kyphoplasty: report of eighty-two thoracolumbar osteoporotic vertebral fractures. J Orthop Trauma. 2004; 18(5):294-299.
36. Stallmeyer MJ, Zoarski GH, Obuchowski AM. Optimizing patient selection in percutaneous vertebroplasty. J Vasc Interv Radiol. 2003; 14(6):683-696.
37. 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.
38. 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.
39. 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.
40. Trout AT, Kallmes DF, Kaufmann TJ.  New fractures after vertebroplasty: adjacent fractures occur significantly sooner. AJNR Am J Neuroradiol. 2006; 27(1):217-223.
41. Truumees E, Hilibrand A, Vaccaro AR. Contemporary Concepts Review: Percutaneous vertebral augmentation. Spine J. 2004; 4(2):218-229.
42. 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.
43. Vasconcelos C, Gailloud P, Beauchamp NJ, Abe M. Is percutaneous vertebroplasty without pretreatment venography safe? Evaluation of 205 consecutive procedures. AJNR Am J Neuroradiol. 2002; 23:913-917.
44. Venmans A, Klazen CA, Lohle PN, et al. Percutaneous vertebroplasty and pulmonary cement embolism: results from VERTOS II. Am J Neuroradiol. 2010; 31(8):1451-1453. 
45. Zoarski GH, Snow P, Olan WJ, et al. Percutaneous vertebroplasty for osteoporotic compression fractures: quantitative prospective evaluation of long-term outcomes. J Vasc Interv Radiol 2002;13:139-148.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Bono CM, Heggeness M, Mick C, Resnick D, Watters WC. North American Spine Society: Newly released vertebroplasty randomized controlled trials: a tale of two trials. Spine J. 2010; 10(3):238-240.
2. Collaborative panel of the American College of Radiology, the American Society of Neuroradiology, the American Society of Interventional and Therapeutic Neuroradiology, and the American Society of Spine Radiology. Practice guideline for the performance of percutaneous vertebroplasty. Reston, VA: American College of Radiology (ACR). 2000. Revised 2009. Available at: http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/iv/percutaneous_vertebroplasty.aspx. Accessed on June 9, 2011.
3. Institute for Clinical Systems Improvement Technology (ISCI). Vertebroplasty and Balloon-Assisted Vertebroplasty for the Treatment of Osteoporotic Compression Fractures. 2003. Available at:  http://www.icsi.org/pain__chronic__assessment_and_management_of_14399/pain__chronic__assessment_and_management_of__guideline_.html. Accessed on June 9, 2011.
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. McGraw JK, Cardella J, Barr JD, et al. Society of Interventional Radiology quality improvement guidelines for percutaneous vertebroplasty. J Vasc Interv Radiol. 2003; 14(suppl):S311-S315.
6. National Institute for Health and Clinical Excellence (NICE). Balloon kyphoplasty for vertebral compression fractures. 2008. Available at: http://www.nice.org.uk/Guidance/IPG166  Accessed on June 9, 2011.
7. National Institute for Health and Clinical Excellence (NICE). Percutaneous vertebroplasty. 2003. Available at: http://www.nice.org.uk/Guidance/IPG12/Guidance/pdf/English  Accessed on June 9, 2011.

1. National Osteoporosis Foundation (NOF) Osteoporosis. What is it? 2004. Available at: http://www.nof.org/aboutosteoporosis/bonebasics/whatisosteoporosis Accessed on: June 9, 2011.

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.