Total ankle replacement (TAR), also known as ankle arthroplasty, is the replacement of an injured ankle joint with an artificial joint. TAR has been used as an alternative to tibiotalar fusion (arthrodesis) in individuals with debilitating end-stage arthritis, loss of ankle function, and pain that is refractory to conservative treatment.
Ankle fusion involves the removal of the articular surfaces of the ankle joint and the fusion of the tibia bone to the talus bone. A fused ankle prevents flexion and extension of the foot and limits side-to-side motion. TAR aims to relieve pain without limiting the ankle’s range of motion or affecting the other leg joints.
A variety of total ankle replacement system designs, including fixed-bearing and mobile-bearing, have received FDA approval for the management of moderate-to-severe tibiotalar pain. The fixed-bearing devices are implanted with cement fixation (e.g., the Agility™ LP Total Ankle Replacement System; the Topez Total Ankle Replacement; the Eclipse Total Ankle Implant; the Inbone™ Total Ankle System; the Salto Talaris Total Ankle Prosthesis; the Infinity™ Total Ankle System). The mobile-bearing Scandinavian Total Ankle Replacement (STAR® system) is indicated for use as a noncemented implant and relies on bearings that move across a surface of polyethylene, a flexible plastic.
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.
Total ankle replacement is considered medically appropriate if ALL of the following are met:
Skeletally mature individuals
Individuals with moderate to severe ankle (tibiotalar) pain that limits daily activity
Documentation of 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 arthritis (e.g., rheumatoid)
ABSENCE of ALL 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
Any specific products referenced in this policy are just examples and are intended for illustrative purposes 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. These examples are contained in the parenthetical e.g. statement.
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.
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.
American College of Foot and Ankle Surgeons (ACFAS). (2020, February). Position statement: Total ankle replacement surgery. Retrieved January 26, 2021 from http://www.acfas.org/.
American Orthopaedic Foot & Ankle Society. (2018, April). Position statement: the use of total ankle replacement for the treatment of arthritic conditions of the ankle. Retrieved January 26, 2021 from http://www.aofas.org/.
DiLorio, A., Viste, A., Fessy, M.H., & Besse, J.L. (2017). The AES total ankle arthroplasty analysis of failures and survivorship at ten years. International Orthopaedics, 41 (12), 2525-2533. Abstract retrieved April 24, 2018 from PubMed database.
Maffuli, N., Longs, U.G., Locher, J., Romeo, G., Salvatore, G., & Denaro, V. (2017). Outcome of ankle arthrodesis and ankle prosthesis: a review of the current status. British Medical Bulletin, 124 (1), 91-112. Abstract retrieved April 24, 2018 from PubMed database.
Onggo, J.R., Nambiar, M., Phan, K., Hickey, B., Galvin, M., & Bedi, H. (2019). Outcome after total ankle arthroplasty with a minimum of five years follow-up: a systematic review and meta-analysis. Foot and Ankle Surgery, 25 (5), 556-563. Abstract retrieved March 10, 2020.
U. S. Food and Drug Administration. (2002, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K020541. Retrieved May 15, 2012 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 May 15, 2012 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 May 15, 2012 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 May 15, 2012 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 May 15, 2012 from http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050050b.pdf.
Winifred A. Hayes, Inc. Medical Technology Directory. (2017, December; last update search April 2020). Comparative effectiveness review of total ankle replacement: a review of reviews. Retrieved January 26, 2021 from www.Hayesinc.com/subscribers. (61 articles and/or guidelines reviewed)
Zaidi, R., Cro, S., Gurusamy, K., Sivanadarajah, N., Macgregor, A., Henricson, A., & Goldberg, A. (2013). The outcome of total ankle replacement: A systematic review and meta-analysis. The Bone and Joint Journal, 95-B (11), 1500-1507. (Level 1 evidence)
ORIGINAL EFFECTIVE DATE: 4/12/2007
MOST RECENT REVIEW DATE: 3/11/2021
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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