| Percutaneous vertebroplasty |
| Intervention |
| ICD-9-CM |
81.65 |
Vertebroplasty and kyphoplasty are similar medical spinal procedures where bone cement is injected through a small hole in the skin (percutaneously) into a fractured vertebra with the goal of relieving the pain of vertebral compression fractures (VCF). Vertebroplasty was found to be ineffective in treating compression fracture of the spine by each of the only two randomized trials done to study the procedure that used a sham procedure for the control group.
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Contents
- 1 History
- 2 Effectiveness
- 2.1 NEJM Articles
- 2.2 Medicare response to NEJM articles
- 2.3 VERTOS II Study
- 3 Procedure
- 4 New Vertebral Fractures
- 5 Kyphoplasty
- 6 Risks
- 7 See also
- 8 References
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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 VCF in the United States, although the distinction has largely gone away since then.[1]
Effectiveness
The effectiveness of vertebroplasty is controversial. Two randomized and blinded trials found no benefit however they have been faulted for not looking at people with acute vertebral fractures.[2] Some have suggested that this procedure only be done in those with fractures less than 6 weeks old (which was not the population of these two trials).[3]
NEJM Articles
Two studies published in The New England Journal of Medicine in 2009 found no benefit to vertebroplasty for compression fractures when compared to a sham procedure :[4]
- In a multicenter, prospective double-blinded randomized controlled trial (RCT) involving 131 participants who were patients with one or two painful osteoporotic vertebral fractures, vertebroplasty did not result in greater improvement than a sham procedure in overall pain, physical functioning, or quality of life at 3 or 6 months after treatment.[5] Jeffrey Jarvik of the University of Washington said his study, funded by the National Institutes of Health, found vertebroplasty had no detectable benefit when compared with procedures that only mimicked such procedures. He advises that "vertebroplasty should not be done any longer, unless it's in the setting of a study."[citation needed]
- In a multicenter, randomized, double-blind, placebo-controlled trial involving 78 participants with osteoporotic vertebral compression fractures, patients who underwent vertebroplasty had improvements in pain and disability measures that were similar to those in patients who underwent a sham procedure.[6] University of Virginia radiologist Avery Evans said his study, which was funded by the Australian government and Cook Medical Inc., found vertebroplasty and sham procedures offered patients nearly identical pain relief.[4]
Several case reports and unblinded studies initially suggested that vertebroplasty provided effective relief of pain.[7][8][9][10] However, none of these studies were comparisons to a placebo.
Nevertheless, many vertebroplasty practitioners and healthcare professional organizations continue to advocate for the procedure.[11][12]
Medicare response to NEJM articles
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 a 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 1 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. It became effective on 20 June 2011 and remains current.[13]
VERTOS II Study
An unblinded study published in 2010 compared vertebroplasty to conservative care with 202 patients. The results were consistent with prior unblinded studies; patients who, knowingly, underwent vertebroplasty reported improvement in pain.[14]
Procedure
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 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.[15]
New Vertebral Fractures
According to Hu and Hart, new adjacent level vertebral compression fractures typically occur when cement leaks into the disc space above and/or below the target vertebral body. In a study regarding this topic, Lin et al. observed that 58% of vertebral bodies adjacent to a disc space with cement leakage experienced successive fractures compared to occurrence of new fractures in 12% of vertebral bodies adjacent to a disc space without cement leakage. In this study, it was hypothesized that the new vertebral fractures resulted from a combination of factors. The patient’s underlying spinal disease (eg, osteoporosis or vertebral metastasis) in conjunction with the alteration in the biomechanics of force transmission through the augmented vertebral body were suspected of increasing the risk of subsequent vertebral fractures post-vertebroplasty. In addition, Lin et al believe that there was increased stress placed on the adjacent vertebral body after vertebroplasty that may have contributed to new fractures, stating that pain reduction and subsequent increased activity by the patient were the contributing factors. Hu and Hart state that multiple retrospective reviews have shown an increased risk of adjacent vertebral body fractures after vertebroplasty and mention a study by Trout et al in which 41.4% of 186 new fractures were adjacent to the treated level in 86 of 432 patients with new fractures. In Trout’s study, it was found that the relative risk of adjacent level was 4.62 times greater than that for nonadjacent level fractures however they could not prove that vertebroplasty was the cause of these adjacent vertebral fractures, stating that they could only suggest a strong association between the two events.
By contrast, a smaller study by Frankel et al found that no new adjacent level fractures were observed within a 3 month period in a sample of 19 patients that had 26 fractures treated via vertebroplasty. In this study, the nineteen patients underwent vertebroplasty using a novel cannulated, fenestrated bone tap that resulted in no radiculopathy from cement extravasation and asymptomatic cement extravasation in only 7.7% of the patients (2 out of 26 treated vertebral fractures).
Kyphoplasty
Cement in a vertebra as seen on plain Xray.
Kyphoplasty is a variation of a vertebroplasty that attempts to stop the pain caused by the bone fracture and 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.
In its review of vertebroplasty and vertebral augmentation procedures, 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."[13]
Effectiveness
Several unblinded clinical studies have suggested a benefit of balloon kyphoplasty for patients with spinal fractures. Earlier unblinded studies also suggested a similar benefit to the closely related procedure vertebroplasty, however the only two blinded randomized controlled studies done to assess vertebroplasty failed to demonstrate any benefit as compared to patients who received a sham procedure.[16][17] Although no blinded studies have been performed on kyphoplasty, since the procedure is a derivative of vertebroplasty, the unsuccessful results of these blinded studies have cast doubt upon the benefit of kyphoplasty despite the continued benefit suggested by unblinded studies.[18]
Risks
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 that can be produced are from the leak of acrylic cement outside of the vertebral body. Although severe complications are extremely rare, it is important to know that infection, bleeding, numbness, tingling, headache, and paralysis may ensue due to 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.[15]
See also
- Osteoporosis
- Back pain
- Vesselplasty
- Interventional Radiology
References
- ^ 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 0-387-29078-8.
- ^ Gangi, A; Clark, WA (2010 Aug). "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.
- ^ 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. PMID 20230351.
- ^ a b "Studies question impact of vertebroplasty." Aug. 6, 2009: UPI.com
- ^ Kallmes, DF; Comstock, BA, Heagerty, PJ, Turner, JA, Wilson, DJ, Diamond, TH, Edwards, R, Gray, LA, Stout, L, Owen, S, Hollingworth, W, Ghdoke, B, Annesley-Williams, DJ, Ralston, SH, Jarvik, JG (2009-08-06). "A randomized trial of vertebroplasty for osteoporotic spinal fractures.". The New England Journal of Medicine 361 (6): 569–79. doi:10.1056/NEJMoa0900563. PMC 2930487. PMID 19657122. //www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2930487.
- ^ Buchbinder, R; Osborne, RH, Ebeling, PR, Wark, JD, Mitchell, P, Wriedt, C, Graves, S, Staples, MP, Murphy, B (2009-08-06). "A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures.". The New England Journal of Medicine 361 (6): 557–68. doi:10.1056/NEJMoa0900429. PMID 19657121.
- ^ [1]
- ^ Hulme PA, Krebs J, Ferguson SJ, Berlemann U (2006). "Vertebroplasty and Kyphoplasty: A Systematic Review of 69 Clinical Studies". Spine 31 (17): 1983–2001. doi:10.1097/01.brs.0000229254.89952.6b. PMID 16924218.
- ^ McGraw JK, Lippert JA, Minkus KD, Rami PM, Davis TM, Budzik RF. "Prospective evaluation of pain relief in 100 patients undergoing percutaneous vertebroplasty: results and follow-up." Journal of Vascular and Interventional Radiology 2002;13(9 pt 1):883-886.
- ^ Layton, KF et al. "Vertebroplasty, First 1000 Levels of a Single Center: Evaluation of the Outcomes and Complications." American Journal of Neuroradiology April 2007,28:683-89
- ^ Moan R. Debate continues over value of vertebroplasty. Diagnostic Imaging. 2010;32(2):5.
- ^ Jensen, ME; McGraw, JK, Cardella, JF, Hirsch, JA (2009 Jul). "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 : JVIR 20 (7 Suppl): S326-31. doi:10.1016/j.jvir.2009.04.022. PMID 19560019.
- ^ 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. http://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=24383&ContrNum=03102. Retrieved 18 October 2011.
- ^ Klazen CA, Lohle PN, de Vries J, et al. (August 2010). "Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomized trial". Lancet 376 (9746): 1085–92. doi:10.1016/S0140-6736(10)60954-3. PMID 20701962.
- ^ 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
- ^ 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. //www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2930487.
- ^ 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. PMID 19657121.
- ^ [2]
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Orthopedic surgery, operations/surgeries and other procedures on bones and joints (ICD-9-CM V3 76–81, ICD-10-PCS 0P–S)
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| Bones |
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Facial
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- Jaw reduction
- Dentofacial osteotomy
- Genioplasty/Mentoplasty
- Orthognathic surgery
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Spine
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- Coccygectomy
- Laminotomy
- Laminectomy
- Laminoplasty
- Corpectomy
- Facetectomy
- Foraminotomy
- Vertebral fixation
- Percutaneous vertebroplasty
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Upper extremity
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Acromioplasty
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Lower extremity
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- Femoral head ostectomy
- Astragalectomy
- Distraction osteogenesis
- Ilizarov apparatus
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General
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- Ostectomy
- Bone grafting
- Osteotomy
- Epiphysiodesis
- Reduction
- Internal fixation
- External fixation
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Medical imaging
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- Dual energy X-ray absorptiometry/Digital X-ray radiogrammetry
- pQCT
- Skeletal survey
- Bone scintigraphy
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| Cartilage |
- Articular cartilage repair
- Knee cartilage replacement therapy
- Autologous chondrocyte implantation
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| Joints |
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Spine
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- Arthrodesis
- Intervertebral discs
- Discectomy
- Annuloplasty
- Arthroplasty
- Back examination
- Straight leg raise
- Waddell's signs
- Schober's test
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Upper extremity
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- Shoulder surgery
- Shoulder replacement
- Bankart repair
- Weaver–Dunn procedure
- Ulnar collateral ligament reconstruction
- Hand surgery
- exam:
- Shoulder examination
- Elbow examination
- Wrist examination
- Tinel sign/Phalen maneuver
- Finkelstein's test
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Lower extremity
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- Hip resurfacing
- Hip replacement
- Rotationplasty
- Anterior cruciate ligament reconstruction
- Knee replacement/Unicompartmental knee arthroplasty
- Ankle replacement
- Broström procedure
- Triple arthrodesis
- exam:
- Hip examination
- Knee examination
- Ankle examination
- CPRs:
- Pittsburgh knee rules
- Ottawa knee rules
- Ottawa ankle rules
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General
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- Arthrotomy
- Arthroplasty
- Synovectomy
- Arthroscopy
- Replacement joint
- imaging: Arthrogram
- Arthrocentesis
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anat(c/f/k/f, u, t/p, l)/phys/devp/cell
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noco/cong/tumr, sysi/epon, injr
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noco(arth/defr/back/soft)/cong, sysi/epon, injr
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