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Wikipedia

Vertebral augmentation

July 19, 2023

Vertebral augmentation, including vertebroplasty and kyphoplasty, refers to similar percutaneous spinal procedures in which bone cement is injected through a small hole in the skin into a fractured vertebra in order to relieve back pain caused by a vertebral compression fracture. After decades of medical research into the efficacy and safety of vertebral augmentation, there is still a lack of consensus regarding certain aspects of vertebroplasty and kyphoplasty.

Percutaneous vertebroplasty
Typical interventional suite setup for kyphoplasty
ICD-9-CM81.65
MedlinePlus007512
[edit on Wikidata]

Procedure

Vertebroplasty and kyphoplasty are the two most common procedures for spinal augmentation. These medical terms are classical compounds of the suffix -plasty meaning "molding or shaping surgically" (from Ancient Greek plastós "molded, formed") and the prefixes vertebro- "vertebra" (from Latin vertebra "joint, joint of the spine") and kypho- "humped; stooping forward" (from Ancient Greek kyphos "crooked").[1]

Vertebroplasty

Vertebroplasty is typically performed by a spine surgeon or interventional radiologist. It is a minimally invasive procedure and patients usually go home the same or next day as the procedure. Patients are given local anesthesia and light sedation for the procedure, though it can be performed using only local anesthetic for patients with medical problems who cannot tolerate sedatives well.

During the procedure, bone cement is injected with a biopsy needle into the collapsed or fractured vertebra. The needle is placed with fluoroscopic x-ray guidance. The cement (most commonly poly methyl methacrylate (PMMA), although more modern cements are used as well) quickly hardens and forms a support structure within the vertebra that provide stabilization and strength. The needle makes a small puncture in the patient's skin that is easily covered with a small bandage after the procedure.[2]

Kyphoplasty

 
Cement in a vertebra as seen on plain Xray.

Kyphoplasty is a variation of a vertebroplasty which attempts to restore the height and angle of kyphosis of a fractured vertebra (of certain types), followed by its stabilization using injected bone cement. The procedure typically includes the use of a small balloon that is inflated in the vertebral body to create a void within the cancellous bone prior to cement delivery. Once the void is created, the procedure continues in a similar manner as a vertebroplasty, but the bone cement is typically delivered directly into the newly created void.[3]

In a 2011 review Medicare contractor NAS determined that there is no difference between vertebroplasty and kyphoplasty, stating, "No clear evidence demonstrates that one procedure is different from another in terms of short- or long-term efficacy, complications, mortality or any other parameter useful for differentiating coverage."[4]

Effectiveness

As of 2019, the effectiveness of vertebroplasty is not supported.[5][6] A 2018 Cochrane review found no role for vertebroplasty for the treatment of acute or sub-acute osteoporotic vertebral fractures.[7] The subjects in these trials had primarily non-acute fractures and prior to the release of the results they were considered the most ideal people to receive the procedure. After trial results were released vertebroplasty advocates pointed out that people with acute vertebral fractures were not investigated.[8][9] A number of non-blinded trials suggested effectiveness,[10] but the lack of blinding limits what can be concluded from the results and some have been criticized because of being funded by the manufacturer.[8] One analysis has attributed the difference to selection bias.[11]

Some have suggested that this procedure only be done in those with fractures less than 8 weeks old;[12] however, analysis of the two blinded trials appear not to support the procedure even in this acute subgroup.[13] Others consider the procedure only appropriate for those with other health problems making rest possibly detrimental, those with metastatic cancer as the cause of the spine fracture, or those who do not improve with conservative management.[14]

Evidence does not support a benefit of kyphoplasty over vertebroplasty with respect to pain, but the procedures may differ in restoring lost vertebral height, and in safety issues like cement extravasation (leakage).[8] As with vertebroplasty, several unblinded studies have suggested a benefit from balloon kyphoplasty.[15][16] As of 2012, no blinded studies have been performed, and since the procedure is a derivative of vertebroplasty, the unsuccessful results of these blinded studies have cast doubt upon the benefit of kyphoplasty generally.[17]

Some vertebroplasty practitioners and some health care professional organizations continue to advocate for the procedure.[18][19][20] In 2010, the board of directors of the American Academy of Orthopaedic Surgeons released a statement recommending strongly against use of vertebroplasty for osteoporotic spinal compression fractures,[21] while the Australian Medical Services Advisory Committee considers both vertebroplasty and kyphoplasty only to be appropriate in those who have failed to improve after a trial of conservative treatment,[22] with conservative treatment (analgesics primarily) being effective in two-thirds of people.[23] The National Institute for Health and Care Excellence similarly states that the procedure in those with osteoporotic fractures is only recommended as an option if there is severe ongoing pain from a recent fracture even with optimal pain management.[24]

Vertebral body stenting, also known by the brand Kiva, is a similar procedure which also has poor evidence to support its use.[6]

Adverse effects

 
A CT image of cement used in kyphoplasty that has entered the spinal channel and is pressing on the spinal cord resulting in neurological symptoms

Some of the associated risks are from the leak of acrylic cement to outside of the vertebral body. Although severe complications are extremely rare, infection, bleeding, numbness, tingling, headache, and paralysis may ensue because of misplacement of the needle or cement. This particular risk is decreased by the use of X-ray or other radiological imaging to ensure proper placement of the cement.[2] In those who have fractures due to cancer, the risk of serious adverse events appears to be greater at 2%.[23]

The risk of new fractures following these procedures does not appear to be changed; however, evidence is limited,[17] and an increase risk as of 2012 is not ruled out.[25] Pulmonary cement embolism is reported to occur in approximately 2-26% of procedures.[26] It may occur with or without symptoms.[26] Typically, if there are no symptoms, there are no long term issues.[26] Symptoms do occur in about 1 in 2000 procedures.[22] Other adverse effects include spinal cord injury in 0.6 per 1000.[22]

Prevalence

In the United States in 2003 approximately 25,000 vertebroplasty procedures were paid for by Medicare.[27] As of 2011/2012 this number may be as high as 70,000-100,000 per year.[28]

History

Vertebroplasty had been performed as an open procedure for many decades to secure pedicle screws and fill tumorous voids. However, the results were not always worth the risk involved with an open procedure, which was the reason for the development of percutaneous vertebroplasty.

The first percutaneous vertebroplasty was performed in 1984 at the University Hospital of Amiens, France to fill a vertebral void left after the removal of a benign spinal tumor. A report of this and 6 other patients was published in 1987 and it was introduced in the United States in the early 1990s. Initially, the treatment was used primarily for tumors in Europe and vertebral compression fractures in the United States, although the distinction has largely gone away since then.[29]

Society and culture

Cost

The cost of vertebroplasty in Europe as of 2010 was ~2,500 Euro.[23] As of 2010 in the United States, when done as an outpatient, vertebroplasty costs around US$3300 while kyphoplasty costs around US$8100 and when done as an inpatient vertebroplasty cost ~US$11,000 and kyphoplasty US$16,000.[30] The cost difference is due to kyphoplasty being an in-patient procedure while vertebroplasty is outpatient, and due to the balloons used in the kyphoplasty procedure.[31] Medicare in 2011 spent about US$1 billion on the procedures.[28] A 2013 study found that "the average adjusted costs for vertebroplasty patients within the first quarter and the first 2 years postsurgery were $14,585 and $44,496, respectively. The corresponding average adjusted costs for kyphoplasty patients were $15,117 and $41,339. There were no significant differences in adjusted costs in the first 9 months postsurgery, but kyphoplasty patients were associated with significantly lower adjusted treatment costs by 6.8–7.9% in the remaining periods through two years postsurgery."[32]

Medicare response

In response to the NEJM articles and a medical record review showing misuse of vertebroplasty and kyphoplasty, US Medicare contractor Noridian Administrative Services (NAS) conducted a literature review and formed a policy regarding reimbursement of the procedures. NAS states that in order to be reimbursable, a procedure must meet certain criteria, including, 1) a detailed and extensively documented medical record showing pain caused by a fracture, 2) radiographic confirmation of a fracture, 3) that other treatment plans were attempted for a reasonable amount of time, 4) that the procedure is not performed in the emergency department, and 5) that at least one year of follow-up is planned for, among others. The policy, as referenced, applies only to the region covered by Noridian and not all of Medicare's coverage area. The reimbursement policy became effective on 20 June 2011.[4] A 2015 comparative study of Medicare patients with vertebral compression fractures found that those who received balloon kyphoplasty and vertebroplasty therapies experienced lower mortality and overall morbidity than those who received conservative nonoperative management.[33]

Promotion

In 2015, it was reported by The Atlantic that a person associated with a medical device company that sells equipment related to the kyphoplasty procedure had edited the Wikipedia article on the subject to promote claims about its efficacy.[34] Assertions about the positive effects of kyphoplasty have been found to be unsupported or disproven, according to independent researchers.[35]

References

  1. ^ Oxford English Dictionary 2009.
  2. ^ a b Nicole Berardoni M.D, Paul Lynch M.D, and Tory McJunkin M.D. "Vertebroplasty and Kyphoplasty" 2008. Accessed 7 Aug 2009. http://www.arizonapain.com/Vertebroplasty-W.html
  3. ^ Wardlaw, Douglas; Van Meirhaeghe, Jan (2012), "Balloon kyphoplasty in patients with osteoporotic vertebral compression fractures", Expert Review of Medical Devices, 9 (4): 423–436, doi:10.1586/erd.12.27, PMID 22905846, S2CID 6448288
  4. ^ a b Noridian Administrative Services, LLC. "Local Coverage Determination (LCD) for Vertebroplasty, Vertebral Augmentation; Percutaneous (L24383)". Centers for Medicare and Medicaid Services. United States Department of Health and Human Services. Retrieved 18 October 2011.
  5. ^ Buchbinder, R; Johnston, RV; Rischin, KJ; Homik, J; Jones, CA; Golmohammadi, K; Kallmes, DF (6 November 2018). "Percutaneous vertebroplasty for osteoporotic vertebral compression fracture". The Cochrane Database of Systematic Reviews. 2018 (11): CD006349. doi:10.1002/14651858.CD006349.pub4. PMC 6517304. PMID 30399208.
  6. ^ a b Ebeling, Peter R; Akesson, Kristina; Bauer, Douglas C; Buchbinder, Rachelle; Eastell, Richard; Fink, Howard A; Giangregorio, Lora; Guanabens, Nuria; Kado, Deborah; Kallmes, David; Katzman, Wendy; Rodriguez, Alexander; Wermers, Robert; Wilson, H Alexander; Bouxsein, Mary L (January 2019). "The Efficacy and Safety of Vertebral Augmentation: A Second ASBMR Task Force Report". Journal of Bone and Mineral Research. 34 (1): 3–21. doi:10.1002/jbmr.3653. PMID 30677181.
  7. ^ Buchbinder, Rachelle; Johnston, Renea V.; Rischin, Kobi J.; Homik, Joanne; Jones, C. Allyson; Golmohammadi, Kamran; Kallmes, David F. (6 November 2018). "Percutaneous vertebroplasty for osteoporotic vertebral compression fracture". The Cochrane Database of Systematic Reviews. 2018 (11): CD006349. doi:10.1002/14651858.CD006349.pub4. ISSN 1469-493X. PMC 6517304. PMID 30399208.
  8. ^ a b c Robinson, Y; Olerud, C (May 2012). "Vertebroplasty and kyphoplasty--a systematic review of cement augmentation techniques for osteoporotic vertebral compression fractures compared to standard medical therapy". Maturitas. 72 (1): 42–9. doi:10.1016/j.maturitas.2012.02.010. PMID 22425141.
  9. ^ Gangi, A; Clark, WA (August 2010). "Have recent vertebroplasty trials changed the indications for vertebroplasty?". CardioVascular and Interventional Radiology. 33 (4): 677–80. doi:10.1007/s00270-010-9901-3. PMID 20523998. S2CID 25901532.
  10. ^ Wardlaw, Douglas; Cummings, Steven (2009), "Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial", Lancet, 373 (9668): 1016–24, doi:10.1016/S0140-6736(09)60010-6, PMID 19246088, S2CID 12241054
  11. ^ McCullough, BJ; Comstock, BA; Deyo, RA; Kreuter, W; Jarvik, JG (Sep 9, 2013). "Major Medical Outcomes With Spinal Augmentation vs Conservative Therapy". JAMA Internal Medicine. 173 (16): 1514–21. doi:10.1001/jamainternmed.2013.8725. PMC 4023124. PMID 23836009.
  12. ^ Clark, WA; Diamond, TH; McNeil, HP; Gonski, PN; Schlaphoff, GP; Rouse, JC (2010-03-15). "Vertebroplasty for painful acute osteoporotic vertebral fractures: recent Medical Journal of Australia editorial is not relevant to the patient group that we treat with vertebroplasty". The Medical Journal of Australia. 192 (6): 334–7. doi:10.5694/j.1326-5377.2010.tb03533.x. PMID 20230351. S2CID 12672714.
  13. ^ Staples, MP; Kallmes, DF; Comstock, BA; Jarvik, JG; Osborne, RH; Heagerty, PJ; Buchbinder, R (Jul 12, 2011). "Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: meta-analysis". BMJ (Clinical Research Ed.). 343: d3952. doi:10.1136/bmj.d3952. PMC 3133975. PMID 21750078.
  14. ^ Itshayek, E; Miller, P; Barzilay, Y; Hasharoni, A; Kaplan, L; Fraifeld, S; Cohen, JE (June 2012). "Vertebral augmentation in the treatment of vertebral compression fractures: review and new insights from recent studies". Journal of Clinical Neuroscience. 19 (6): 786–91. doi:10.1016/j.jocn.2011.12.015. PMID 22595547. S2CID 8301676.
  15. ^ Kallmes DF, Comstock BA, Heagerty PJ, et al. (August 2009). "A randomized trial of vertebroplasty for osteoporotic spinal fractures". N. Engl. J. Med. 361 (6): 569–79. doi:10.1056/NEJMoa0900563. PMC 2930487. PMID 19657122.
  16. ^ Buchbinder R, Osborne RH, Ebeling PR, et al. (August 2009). "A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures". N. Engl. J. Med. 361 (6): 557–68. doi:10.1056/NEJMoa0900429. hdl:10536/DRO/DU:30019842. PMID 19657121.
  17. ^ a b Zou, J; Mei, X; Zhu, X; Shi, Q; Yang, H (Jul–Aug 2012). "The long-term incidence of subsequent vertebral body fracture after vertebral augmentation therapy: a systemic review and meta-analysis". Pain Physician. 15 (4): E515–22. PMID 22828697.
  18. ^ Moan R. continues over value of vertebroplasty. Diagnostic Imaging. 2010;32(2) 5.
  19. ^ Jensen, ME; McGraw, JK; Cardella, JF; Hirsch, JA (July 2009). "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". Journal of Vascular and Interventional Radiology. 20 (7 Suppl): S326–31. doi:10.1016/j.jvir.2009.04.022. PMID 19560019.
  20. ^ Clark, William; Bird, Paul; Diamond, Terrance; Gonski, Peter; Gebski, Val (9 March 2019). "Cochrane vertebroplasty review misrepresented evidence for vertebroplasty with early intervention in severely affected patients". BMJ Evidence-Based Medicine. 25 (online first): bmjebm–2019–111171. doi:10.1136/bmjebm-2019-111171. PMC 7286037. PMID 30852489.
  21. ^ Esses, Stephen I.; et al. (September 2010), The Treatment of Symptomatic Osteoporotic Spinal Compression Fractures: Guideline and Evidence Report (PDF), American Academy of Orthopaedic Surgeons
  22. ^ a b c Review of interim funded service: Vertebroplasty and New review of Kyphoplasty (PDF). Medical Services Advisory Committee. April 2011. ISBN 9781742414560.
  23. ^ a b c Montagu, A; Speirs, A; Baldock, J; Corbett, J; Gosney, M (July 2012). "A review of vertebroplasty for osteoporotic and malignant vertebral compression fractures". Age and Ageing. 41 (4): 450–5. doi:10.1093/ageing/afs024. PMID 22417981.
  24. ^ . NICE The National Institute for Health and Care Excellence. April 2013. p. 3. Archived from the original on 2 April 2015. Retrieved 17 March 2015.
  25. ^ Bliemel, C; Oberkircher, L; Buecking, B; Timmesfeld, N; Ruchholtz, S; Krueger, A (April 2012). "Higher incidence of new vertebral fractures following percutaneous vertebroplasty and kyphoplasty--fact or fiction?". Acta Orthopaedica Belgica. 78 (2): 220–9. PMID 22696994.
  26. ^ a b c Wang, LJ; Yang, HL; Shi, YX; Jiang, WM; Chen, L (August 2012). "Pulmonary cement embolism associated with percutaneous vertebroplasty or kyphoplasty: a systematic review". Orthopaedic Surgery. 4 (3): 182–9. doi:10.1111/j.1757-7861.2012.00193.x. PMC 6583132. PMID 22927153.
  27. ^ Morrison, WB; Parker, L; Frangos, AJ; Carrino, JA (April 2007). "Vertebroplasty in the United States: guidance method and provider distribution, 2001-2003". Radiology. 243 (1): 166–70. doi:10.1148/radiol.2431060045. PMID 17392252.
  28. ^ a b REDBERG, Rita (May 25, 2011). "Squandering Medicare's Money". New York Times. Retrieved 18 January 2013.
  29. ^ Mathis, John M.; Deramond, Hervé; Belkoff, Stephen M., eds. (2006) [First edition published 2002]. Percutaneous Vertebroplasty and Kyphoplasty (2nd ed.). Springer Science+Business Media. pp. 3–5. ISBN 978-0-387-29078-2.
  30. ^ Mehio, AK; Lerner, JH; Engelhart, LM; Kozma, CM; Slaton, TL; Edwards, NC; Lawler, GJ (August 2011). "Comparative hospital economics and patient presentation: vertebroplasty and kyphoplasty for the treatment of vertebral compression fracture". AJNR. American Journal of Neuroradiology. 32 (7): 1290–4. doi:10.3174/ajnr.A2502. PMC 7966060. PMID 21546460.
  31. ^ Cloft, HJ; Jensen, ME (February 2007). "Kyphoplasty: an assessment of a new technology". AJNR. American Journal of Neuroradiology. 28 (2): 200–3. PMC 7977394. PMID 17296979.
  32. ^ Ong, KL; Lau, E; Kemner, JE; Kurtz, SM (April 2013). "Two-year cost comparison of vertebroplasty and kyphoplasty for the treatment of vertebral compression fractures: are initial surgical costs misleading?". Osteoporosis International. 24 (4): 1437–45. doi:10.1007/s00198-012-2100-0. PMID 22872070. S2CID 22020223.
  33. ^ Edidin, Avram; Ong, Kevin (2015), "Morbidity and Mortality After Vertebral Fractures: Comparison of Vertebral Augmentation and Nonoperative Management in the Medicare Population", Spine, 40 (15): 1228–41, doi:10.1097/BRS.0000000000000992, PMID 26020845, S2CID 20164158
  34. ^ Pinsker, Story by Joe. "The Covert World of People Trying to Edit Wikipedia—for Pay". The Atlantic. ISSN 1072-7825. Retrieved 2020-05-26.
  35. ^ Kolata, Gina (2019-01-24). "Spinal Fractures Can Be Terribly Painful. A Common Treatment Isn't Helping". The New York Times. ISSN 0362-4331. Retrieved 2020-05-26.

External links

 
Wikimedia Commons has media related to Percutaneous vertebroplasty.
  • Spinal Fractures Can Be Terribly Painful. A Common Treatment Isn't Helping. NYTs 2019

July 19, 2023
vertebral, augmentation, including, vertebroplasty, kyphoplasty, refers, similar, percutaneous, spinal, procedures, which, bone, cement, injected, through, small, hole, skin, into, fractured, vertebra, order, relieve, back, pain, caused, vertebral, compression. Vertebral augmentation including vertebroplasty and kyphoplasty refers to similar percutaneous spinal procedures in which bone cement is injected through a small hole in the skin into a fractured vertebra in order to relieve back pain caused by a vertebral compression fracture After decades of medical research into the efficacy and safety of vertebral augmentation there is still a lack of consensus regarding certain aspects of vertebroplasty and kyphoplasty Percutaneous vertebroplastyTypical interventional suite setup for kyphoplastyICD 9 CM81 65MedlinePlus007512 edit on Wikidata Contents 1 Procedure 1 1 Vertebroplasty 1 2 Kyphoplasty 2 Effectiveness 3 Adverse effects 4 Prevalence 5 History 6 Society and culture 6 1 Cost 6 2 Medicare response 6 3 Promotion 7 References 8 External linksProcedureVertebroplasty and kyphoplasty are the two most common procedures for spinal augmentation These medical terms are classical compounds of the suffix plasty meaning molding or shaping surgically from Ancient Greek plastos molded formed and the prefixes vertebro vertebra from Latin vertebra joint joint of the spine and kypho humped stooping forward from Ancient Greek kyphos crooked 1 Vertebroplasty Vertebroplasty is typically performed by a spine surgeon or interventional radiologist It is a minimally invasive procedure and patients usually go home the same or next day as the procedure Patients are given local anesthesia and light sedation for the procedure though it can be performed using only local anesthetic for patients with medical problems who cannot tolerate sedatives well During the procedure bone cement is injected with a biopsy needle into the collapsed or fractured vertebra The needle is placed with fluoroscopic x ray guidance The cement most commonly poly methyl methacrylate PMMA although more modern cements are used as well quickly hardens and forms a support structure within the vertebra that provide stabilization and strength The needle makes a small puncture in the patient s skin that is easily covered with a small bandage after the procedure 2 Kyphoplasty Cement in a vertebra as seen on plain Xray Kyphoplasty is a variation of a vertebroplasty which attempts to restore the height and angle of kyphosis of a fractured vertebra of certain types followed by its stabilization using injected bone cement The procedure typically includes the use of a small balloon that is inflated in the vertebral body to create a void within the cancellous bone prior to cement delivery Once the void is created the procedure continues in a similar manner as a vertebroplasty but the bone cement is typically delivered directly into the newly created void 3 In a 2011 review Medicare contractor NAS determined that there is no difference between vertebroplasty and kyphoplasty stating No clear evidence demonstrates that one procedure is different from another in terms of short or long term efficacy complications mortality or any other parameter useful for differentiating coverage 4 EffectivenessAs of 2019 the effectiveness of vertebroplasty is not supported 5 6 A 2018 Cochrane review found no role for vertebroplasty for the treatment of acute or sub acute osteoporotic vertebral fractures 7 The subjects in these trials had primarily non acute fractures and prior to the release of the results they were considered the most ideal people to receive the procedure After trial results were released vertebroplasty advocates pointed out that people with acute vertebral fractures were not investigated 8 9 A number of non blinded trials suggested effectiveness 10 but the lack of blinding limits what can be concluded from the results and some have been criticized because of being funded by the manufacturer 8 One analysis has attributed the difference to selection bias 11 Some have suggested that this procedure only be done in those with fractures less than 8 weeks old 12 however analysis of the two blinded trials appear not to support the procedure even in this acute subgroup 13 Others consider the procedure only appropriate for those with other health problems making rest possibly detrimental those with metastatic cancer as the cause of the spine fracture or those who do not improve with conservative management 14 Evidence does not support a benefit of kyphoplasty over vertebroplasty with respect to pain but the procedures may differ in restoring lost vertebral height and in safety issues like cement extravasation leakage 8 As with vertebroplasty several unblinded studies have suggested a benefit from balloon kyphoplasty 15 16 As of 2012 update no blinded studies have been performed and since the procedure is a derivative of vertebroplasty the unsuccessful results of these blinded studies have cast doubt upon the benefit of kyphoplasty generally 17 Some vertebroplasty practitioners and some health care professional organizations continue to advocate for the procedure 18 19 20 In 2010 the board of directors of the American Academy of Orthopaedic Surgeons released a statement recommending strongly against use of vertebroplasty for osteoporotic spinal compression fractures 21 while the Australian Medical Services Advisory Committee considers both vertebroplasty and kyphoplasty only to be appropriate in those who have failed to improve after a trial of conservative treatment 22 with conservative treatment analgesics primarily being effective in two thirds of people 23 The National Institute for Health and Care Excellence similarly states that the procedure in those with osteoporotic fractures is only recommended as an option if there is severe ongoing pain from a recent fracture even with optimal pain management 24 Vertebral body stenting also known by the brand Kiva is a similar procedure which also has poor evidence to support its use 6 Adverse effects A CT image of cement used in kyphoplasty that has entered the spinal channel and is pressing on the spinal cord resulting in neurological symptomsSome of the associated risks are from the leak of acrylic cement to outside of the vertebral body Although severe complications are extremely rare infection bleeding numbness tingling headache and paralysis may ensue because of misplacement of the needle or cement This particular risk is decreased by the use of X ray or other radiological imaging to ensure proper placement of the cement 2 In those who have fractures due to cancer the risk of serious adverse events appears to be greater at 2 23 The risk of new fractures following these procedures does not appear to be changed however evidence is limited 17 and an increase risk as of 2012 is not ruled out 25 Pulmonary cement embolism is reported to occur in approximately 2 26 of procedures 26 It may occur with or without symptoms 26 Typically if there are no symptoms there are no long term issues 26 Symptoms do occur in about 1 in 2000 procedures 22 Other adverse effects include spinal cord injury in 0 6 per 1000 22 PrevalenceIn the United States in 2003 approximately 25 000 vertebroplasty procedures were paid for by Medicare 27 As of 2011 2012 this number may be as high as 70 000 100 000 per year 28 HistoryVertebroplasty had been performed as an open procedure for many decades to secure pedicle screws and fill tumorous voids However the results were not always worth the risk involved with an open procedure which was the reason for the development of percutaneous vertebroplasty The first percutaneous vertebroplasty was performed in 1984 at the University Hospital of Amiens France to fill a vertebral void left after the removal of a benign spinal tumor A report of this and 6 other patients was published in 1987 and it was introduced in the United States in the early 1990s Initially the treatment was used primarily for tumors in Europe and vertebral compression fractures in the United States although the distinction has largely gone away since then 29 Society and cultureCost The cost of vertebroplasty in Europe as of 2010 was 2 500 Euro 23 As of 2010 in the United States when done as an outpatient vertebroplasty costs around US 3300 while kyphoplasty costs around US 8100 and when done as an inpatient vertebroplasty cost US 11 000 and kyphoplasty US 16 000 30 The cost difference is due to kyphoplasty being an in patient procedure while vertebroplasty is outpatient and due to the balloons used in the kyphoplasty procedure 31 Medicare in 2011 spent about US 1 billion on the procedures 28 A 2013 study found that the average adjusted costs for vertebroplasty patients within the first quarter and the first 2 years postsurgery were 14 585 and 44 496 respectively The corresponding average adjusted costs for kyphoplasty patients were 15 117 and 41 339 There were no significant differences in adjusted costs in the first 9 months postsurgery but kyphoplasty patients were associated with significantly lower adjusted treatment costs by 6 8 7 9 in the remaining periods through two years postsurgery 32 Medicare response In response to the NEJM articles and a medical record review showing misuse of vertebroplasty and kyphoplasty US Medicare contractor Noridian Administrative Services NAS conducted a literature review and formed a policy regarding reimbursement of the procedures NAS states that in order to be reimbursable a procedure must meet certain criteria including 1 a detailed and extensively documented medical record showing pain caused by a fracture 2 radiographic confirmation of a fracture 3 that other treatment plans were attempted for a reasonable amount of time 4 that the procedure is not performed in the emergency department and 5 that at least one year of follow up is planned for among others The policy as referenced applies only to the region covered by Noridian and not all of Medicare s coverage area The reimbursement policy became effective on 20 June 2011 4 A 2015 comparative study of Medicare patients with vertebral compression fractures found that those who received balloon kyphoplasty and vertebroplasty therapies experienced lower mortality and overall morbidity than those who received conservative nonoperative management 33 Promotion In 2015 it was reported by The Atlantic that a person associated with a medical device company that sells equipment related to the kyphoplasty procedure had edited the Wikipedia article on the subject to promote claims about its efficacy 34 Assertions about the positive effects of kyphoplasty have been found to be unsupported or disproven according to independent researchers 35 References Oxford English Dictionary 2009 a b Nicole Berardoni M D Paul Lynch M D and Tory McJunkin M D Vertebroplasty and Kyphoplasty 2008 Accessed 7 Aug 2009 http www arizonapain com Vertebroplasty W html Wardlaw Douglas Van Meirhaeghe Jan 2012 Balloon kyphoplasty in patients with osteoporotic vertebral compression fractures Expert Review of Medical Devices 9 4 423 436 doi 10 1586 erd 12 27 PMID 22905846 S2CID 6448288 a b Noridian Administrative Services LLC Local Coverage Determination LCD for Vertebroplasty Vertebral Augmentation Percutaneous L24383 Centers for Medicare and Medicaid Services United States Department of Health and Human Services Retrieved 18 October 2011 Buchbinder R Johnston RV Rischin KJ Homik J Jones CA Golmohammadi K Kallmes DF 6 November 2018 Percutaneous vertebroplasty for osteoporotic vertebral compression fracture The Cochrane Database of Systematic Reviews 2018 11 CD006349 doi 10 1002 14651858 CD006349 pub4 PMC 6517304 PMID 30399208 a b Ebeling Peter R Akesson Kristina Bauer Douglas C Buchbinder Rachelle Eastell Richard Fink Howard A Giangregorio Lora Guanabens Nuria Kado Deborah Kallmes David Katzman Wendy Rodriguez Alexander Wermers Robert Wilson H Alexander Bouxsein Mary L January 2019 The Efficacy and Safety of Vertebral Augmentation A Second ASBMR Task Force Report Journal of Bone and Mineral Research 34 1 3 21 doi 10 1002 jbmr 3653 PMID 30677181 Buchbinder Rachelle Johnston Renea V Rischin Kobi J Homik Joanne Jones C Allyson Golmohammadi Kamran Kallmes David F 6 November 2018 Percutaneous vertebroplasty for osteoporotic vertebral compression fracture The Cochrane Database of Systematic Reviews 2018 11 CD006349 doi 10 1002 14651858 CD006349 pub4 ISSN 1469 493X PMC 6517304 PMID 30399208 a b c Robinson Y Olerud C May 2012 Vertebroplasty and kyphoplasty a systematic review of cement augmentation techniques for osteoporotic vertebral compression fractures compared to standard medical therapy Maturitas 72 1 42 9 doi 10 1016 j maturitas 2012 02 010 PMID 22425141 Gangi A Clark WA August 2010 Have recent vertebroplasty trials changed the indications for vertebroplasty CardioVascular and Interventional Radiology 33 4 677 80 doi 10 1007 s00270 010 9901 3 PMID 20523998 S2CID 25901532 Wardlaw Douglas Cummings Steven 2009 Efficacy and safety of balloon kyphoplasty compared with non surgical care for vertebral compression fracture FREE a randomised controlled trial Lancet 373 9668 1016 24 doi 10 1016 S0140 6736 09 60010 6 PMID 19246088 S2CID 12241054 McCullough BJ Comstock BA Deyo RA Kreuter W Jarvik JG Sep 9 2013 Major Medical Outcomes With Spinal Augmentation vs Conservative Therapy JAMA Internal Medicine 173 16 1514 21 doi 10 1001 jamainternmed 2013 8725 PMC 4023124 PMID 23836009 Clark WA Diamond TH McNeil HP Gonski PN Schlaphoff GP Rouse JC 2010 03 15 Vertebroplasty for painful acute osteoporotic vertebral fractures recent Medical Journal of Australia editorial is not relevant to the patient group that we treat with vertebroplasty The Medical Journal of Australia 192 6 334 7 doi 10 5694 j 1326 5377 2010 tb03533 x PMID 20230351 S2CID 12672714 Staples MP Kallmes DF Comstock BA Jarvik JG Osborne RH Heagerty PJ Buchbinder R Jul 12 2011 Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials meta analysis BMJ Clinical Research Ed 343 d3952 doi 10 1136 bmj d3952 PMC 3133975 PMID 21750078 Itshayek E Miller P Barzilay Y Hasharoni A Kaplan L Fraifeld S Cohen JE June 2012 Vertebral augmentation in the treatment of vertebral compression fractures review and new insights from recent studies Journal of Clinical Neuroscience 19 6 786 91 doi 10 1016 j jocn 2011 12 015 PMID 22595547 S2CID 8301676 Kallmes DF Comstock BA Heagerty PJ et al August 2009 A randomized trial of vertebroplasty for osteoporotic spinal fractures N Engl J Med 361 6 569 79 doi 10 1056 NEJMoa0900563 PMC 2930487 PMID 19657122 Buchbinder R Osborne RH Ebeling PR et al August 2009 A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures N Engl J Med 361 6 557 68 doi 10 1056 NEJMoa0900429 hdl 10536 DRO DU 30019842 PMID 19657121 a b Zou J Mei X Zhu X Shi Q Yang H Jul Aug 2012 The long term incidence of subsequent vertebral body fracture after vertebral augmentation therapy a systemic review and meta analysis Pain Physician 15 4 E515 22 PMID 22828697 Moan R continues over value of vertebroplasty Diagnostic Imaging 2010 32 2 5 Jensen ME McGraw JK Cardella JF Hirsch JA July 2009 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 Journal of Vascular and Interventional Radiology 20 7 Suppl S326 31 doi 10 1016 j jvir 2009 04 022 PMID 19560019 Clark William Bird Paul Diamond Terrance Gonski Peter Gebski Val 9 March 2019 Cochrane vertebroplasty review misrepresented evidence for vertebroplasty with early intervention in severely affected patients BMJ Evidence Based Medicine 25 online first bmjebm 2019 111171 doi 10 1136 bmjebm 2019 111171 PMC 7286037 PMID 30852489 Esses Stephen I et al September 2010 The Treatment of Symptomatic Osteoporotic Spinal Compression Fractures Guideline and Evidence Report PDF American Academy of Orthopaedic Surgeons a b c Review of interim funded service Vertebroplasty and New review of Kyphoplasty PDF Medical Services Advisory Committee April 2011 ISBN 9781742414560 a b c Montagu A Speirs A Baldock J Corbett J Gosney M July 2012 A review of vertebroplasty for osteoporotic and malignant vertebral compression fractures Age and Ageing 41 4 450 5 doi 10 1093 ageing afs024 PMID 22417981 Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures NICE The National Institute for Health and Care Excellence April 2013 p 3 Archived from the original on 2 April 2015 Retrieved 17 March 2015 Bliemel C Oberkircher L Buecking B Timmesfeld N Ruchholtz S Krueger A April 2012 Higher incidence of new vertebral fractures following percutaneous vertebroplasty and kyphoplasty fact or fiction Acta Orthopaedica Belgica 78 2 220 9 PMID 22696994 a b c Wang LJ Yang HL Shi YX Jiang WM Chen L August 2012 Pulmonary cement embolism associated with percutaneous vertebroplasty or kyphoplasty a systematic review Orthopaedic Surgery 4 3 182 9 doi 10 1111 j 1757 7861 2012 00193 x PMC 6583132 PMID 22927153 Morrison WB Parker L Frangos AJ Carrino JA April 2007 Vertebroplasty in the United States guidance method and provider distribution 2001 2003 Radiology 243 1 166 70 doi 10 1148 radiol 2431060045 PMID 17392252 a b REDBERG Rita May 25 2011 Squandering Medicare s Money New York Times Retrieved 18 January 2013 Mathis John M Deramond Herve Belkoff Stephen M eds 2006 First edition published 2002 Percutaneous Vertebroplasty and Kyphoplasty 2nd ed Springer Science Business Media pp 3 5 ISBN 978 0 387 29078 2 Mehio AK Lerner JH Engelhart LM Kozma CM Slaton TL Edwards NC Lawler GJ August 2011 Comparative hospital economics and patient presentation vertebroplasty and kyphoplasty for the treatment of vertebral compression fracture AJNR American Journal of Neuroradiology 32 7 1290 4 doi 10 3174 ajnr A2502 PMC 7966060 PMID 21546460 Cloft HJ Jensen ME February 2007 Kyphoplasty an assessment of a new technology AJNR American Journal of Neuroradiology 28 2 200 3 PMC 7977394 PMID 17296979 Ong KL Lau E Kemner JE Kurtz SM April 2013 Two year cost comparison of vertebroplasty and kyphoplasty for the treatment of vertebral compression fractures are initial surgical costs misleading Osteoporosis International 24 4 1437 45 doi 10 1007 s00198 012 2100 0 PMID 22872070 S2CID 22020223 Edidin Avram Ong Kevin 2015 Morbidity and Mortality After Vertebral Fractures Comparison of Vertebral Augmentation and Nonoperative Management in the Medicare Population Spine 40 15 1228 41 doi 10 1097 BRS 0000000000000992 PMID 26020845 S2CID 20164158 Pinsker Story by Joe The Covert World of People Trying to Edit Wikipedia for Pay The Atlantic ISSN 1072 7825 Retrieved 2020 05 26 Kolata Gina 2019 01 24 Spinal Fractures Can Be Terribly Painful A Common Treatment Isn t Helping The New York Times ISSN 0362 4331 Retrieved 2020 05 26 External links Wikimedia Commons has media 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