DESCRIPTION
The ankle joint is a comparatively small joint relative to the weight bearing and torque it must withstand. These factors have made the design of total ankle joint replacements technically challenging. Total ankle replacements have been investigated since the 1970s, with initially promising results, but the procedure was essentially abandoned in the 1980s due to a high long-term failure rate, both in terms of pain control and improved function. Newer models have since been developed, which can be broadly subdivided into two design types, fixed bearing and mobile bearing.
Fixed-bearing designs lock the polyethylene component into the baseplate, which provides greater stability, but increases constraint and edge-loading stress at the bone implant interface, potentially increasing risk of early loosening and failure. The fixed-bearing devices are implanted with cement fixation (e.g., the Agility Ankle Revision; the Topez Total Ankle Replacement; the Eclipse Total Ankle Implant; the Inbone™ Total Ankle System; the Salto Talaris Total Ankle Prosthesis).
Mobile-bearing systems have a polyethelene component that is unattached and articulates independently with both the tibial and talar components. The 3-piece mobile-bearing prostheses are designed to reduce constraint and edge loading, but are less stable than fixed-bearing designs and have the potential for dislocation and increased wear of the polyethylene component. Mobile-bearing designs are intended for uncemented implantation (e.g., Scandinavian Total Ankle Replacement (S.T.A.R. Ankle)) and have a porous coating on the components to encourage osseo-integration. The Buechel-Pappas device and the TNK ankle are additional mobile bearing devices, however they not approved for use by the FDA.
POLICY
Total ankle replacement is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Total ankle replacement for the treatment of other conditions/diseases is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Total ankle replacement is considered medically appropriate if ALL of the following criteria are met:
ALL of the following:
Skeletally mature individuals
Individuals with moderate to severe ankle (tibiotalar) pain that limits daily activity
ANY ONE of the following:
Arthritis in adjacent joints (i.e., subtalar or midfoot)
Severe arthritis of the contralateral ankle
Arthrodesis of the contralateral ankle
Inflammatory (e.g., rheumatoid) arthritis
ABSENCE of ALL of the following:
Extensive avascular necrosis of the talar dome
Compromised bone stock or soft tissue, including skin and muscle involving the ankle
Severe malalignment (e.g., > 15 degrees) not correctable by surgery
Active ankle joint infection
Peripheral vascular disease
Charcot neuroarthropathy
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Published evidence of well-designed studies in peer review journals and randomized controlled trials with long-term follow-up are not available for other conditions/diseases.
SOURCES
American College of Foot & Ankle Surgeons (ACFAS). (2010, March). ACFAS position statement on total ankle replacement surgery. Retrieved June 15, 2010 from http://www.acfas.org/Physicians/Content.aspx?id=1933.
American Orthopaedic Foot & Ankle Society (AOFAS). (2009, August). Position statement: Total ankle replacement surgery. Retrieved June 11, 2010 from http://www.aofas.org/userfiles/file/PatientEd/TAR_0809.pdf.
Bestic, J. M., Peterson, J. J., DeOrio, J. K., Bancroft, L. W., Berquist, T. H. & Kransdorf, M. J. (2008). Postoperative evaluation of the total ankle arthroplasty. AJR. American Journal of Roentgenology, 190 (4), 1112-1123.
BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2009). Total ankle replacement (7.01.77) Retrieved June 11, 2010 from BlueWeb. (22 articles and/or guidelines)
Canale, S. T. & Beaty, J. H. (Eds.). (2008). Campbell’s Operative Orthopaedics (11th ed., Chapter 5). Philadelphia: Mosby Elsevier.
Diel, P., Thier, C., Aghayey, E., Preis, M., Dudda, M., Espinosa, N., et al. (2010). The International Documentation and Evaluation System IDES: A single center observational case series for development of an ankle prosthesis documentation questionnaire and study of its feasibility and face validity. Journal of Foot and Ankle Research, 3 (4), 1-8. (Level 4 Evidence - Independent study)
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2009, November). Total ankle replacement for degenerative ankle disease. Retrieved June 11, 2010 from ECRI Institute. (38 articles and/or guidelines reviewed)
Goldman, L., & Ausiello, D. (Eds.). (2008).Cecil Medicine (23rd ed., Chapter 299). Philadelphia: Saunders Elsevier.
Gougoulias, N., Khanna, A., & Maffulli, N. (2010). How successful are current ankle replacements? A systematic review of the literature. Clinical Orthopaedics and Related Research, 468 (1), 199-208.
Ishikawa, S. N. (2008). Total ankle arthroplasty. In Canale & Beaty (Eds.), Campbell’s operative orthopaedics (11th ed., Chapter 5). Philadelphia: Mosby Elsevier.
Kurup, H. V, & Taylor, G. R. (2008). Medial impingement after ankle replacement. International Orthopaedics, 32 (2), 243-246.
Saltzman, C. L., Kadoko, R. G., & Suh, J. S. (2010). Treatment of isolated ankle osteoarthritis with arthrodesis or the total ankle replacement: A comparison of early outcomes. Clinics in Orthopedic Surgery, 2 (1), 1-7. (Level 2 Evidence - Independent study)
Saltzman, C. L., Mann, R. A., Ahrens, J. E., Amendola, A., Anderson, R. B., Berlet, G. C., et al. (2009). Prospective controlled trial of STAR total ankle replacement versus ankle fusion: Initial results. Foot & Ankle International, 30 (7), 579-596. (Level 1 Evidence - Industry sponsored)
U. S. Food and Drug Administration. (2002, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K020541. Retrieved June 11, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf2/K020541.pdf.
U. S. Food and Drug Administration. (2005, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K051023. Retrieved June 11, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf5/K051023.pdf.
U. S. Food and Drug Administration. (2006, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K061749. Retrieved June 11, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf6/K061749.pdf.
U. S. Food and Drug Administration. (2009, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K090076. Retrieved June 15, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090076.pdf.
U. S. Food and Drug Administration. (2009, May). Center for Devices and Radiological Health. Scandinavian total ankle replacement (S.T.A.R. ankle)) - P050050. Retrieved June 14, 2010 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=11149.
van der Heide, H. J., Schutte, B., Louwerens, J. W., van den Hoogen, F. H., & Malefijt, M. C. (2009). Total ankle prostheses in rheumatoid arthropathy: Outcome in 52 patients followed for 1-9 years. Acta Orthopaedica, 80 (4), 440-444. (Level 2 Evidence - Independent study)
Winifred S. Hayes. Medical Technology Directory. (2010, February). Total ankle replacement. Retrieved June 1, 2010 from www.Hayesinc.com/subscribers. (73 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 4/12/2007
MOST RECENT REVIEW DATE: 12/11/2010
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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