BlueCross BlueShield of Tennessee Medical Policy Manual

Total Ankle Replacement

DESCRIPTION

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.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

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 and Ankle Surgeons (ACFAS). (2016, July). Position statement: Total ankle replacement surgery. Retrieved April 24, 2018 from http://www.acfas.org/positions/.

American Orthopaedic Foot & Ankle Society. (2014, March). Position statement: the use of total ankle replacement for the treatment of arthritic conditions of the ankle. Retrieved July 2, 2015 from http://www.aofas.org/medical-community/health-policy/Documents/Total-Ankle-Replacement-Position-Statement-3-2014-FINAL.pdf.

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.

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). Total ankle replacement: a review of reviews. Retrieved April 24, 2018 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:  5/9/2019

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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