Indications

Total ankle replacement may be considered medically necessary for treatment of debilitating end-stage ankle arthritis when ALL of the following indications are met:

• The patient is skeletally mature (skeletal maturity implies radiographic closure of the epiphyseal growth plates and cessation of vertical growth); AND
  
  
• There is moderate to severe ankle (tibiotalar) pain that significantly limits daily activity; AND
  
  
• At least 6 months of conservative treatment (such as anti-inflammatory medication, physical therapy, splints or orthotic devices as indicated) has been tried and has failed to provide improvement; AND
  
  
• An FDA-approved device is used.

AT LEAST ONE of the following indications must also be present:

1. Arthritis in adjacent joints (i.e. subtalar or midfoot); OR
2. Severe arthritis of the contralateral ankle; OR
3. Arthrodesis (fusion) of the contralateral ankle; OR
4. Inflammatory (e.g., rheumatoid) arthritis

Total ankle replacement is considered not medically necessary if the indications above are not met. 

Revision to an existing prosthetic ankle implant is eligible when there is infection, inflammatory reaction, mechanical or other complication.

Limitations

Total ankle replacement is contraindicated and is considered not medically necessary when any of the following are present:

• Extensive avascular necrosis of the talar dome;
• Comprised bone stuck or soft tissue (including skin and muscle);
• Severe malalignment (eg., >15 degrees) not correctable by surgery;
• Active ankle joint infection;
• Peripheral vascular disease;
• Charcot neuroneuropathy.

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

Description

Total ankle replacement, or arthroplasty, involves the surgical removal of a dysfunctional and painful ankle joint and replacement with a prosthetic ankle.  Arthritic ankle joints frequently result in decreased range of motion, swelling, joint stiffness, pain with weight-bearing activity, instability secondary to pain, and visible joint deformity.  Conservative management typically consists of pain control medications, activity limitation, stabilization with bracing, shoe modifications, heat, and physical therapy.  When conservative management fails, ankle arthrodesis or fusion of the joint, has been the standard surgical treatment.  Fusion of the ankle joint provides control of the pain of severe ankle arthritis, but results in limited joint movement.  Total ankle replacement has been developed as an alternative to surgical joint fusion.  Total ankle replacement relieves pain and restores joint function/mobility in patients with medically refractory, end-stage degenerative joint disease that has resulted from such conditions as severe osteoarthritis, severe post-traumatic arthritis, or rheumatoid arthritis. 

Place of Service: Inpatient

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Lee KB, Cho SG, Hur Cl, et al. Perioperative complications of HINTEGRA total ankle replacement; our initial 50 cases. Foot Ankle Int. 2008;29(10):978-84.

Schutte BG, Louwerens JW. Short-term results of our first 49 Scandinavian total ankle replacement  (STAR). Foot Ankle Int. 2008;29(2):124-7

Wood PL, Prem H, Sutton C. Total ankle replacement: medium-term results in 200 Scandinavian total ankle replacements. J Bone Joint Surg Br.2008;90(5):605-9.

Besse JL, Brito N, Lienhart C. Clinical evaluation and radiographic assessment of bone lysis of the AES total ankle replacement. Foot Ankle Int.2009;30(10):964-75.

Claridge RJ, Sagherian BH. Intermediate term outcome of the agility total ankle arthroplasty. Foot Ankle Int. 2009;30(9):824-35. 

Glazebrook MA, Arsenault K, Dunbar M. Evidence-based classification of complications in total ankle arthroplasty. Foot Ankle Int. 2009;30(10):945-9.

Jensen NC, Linde F. Long-term follow-up on 33 TPR ankle joint replacements in 26 patients, with rheumatoid arthritis. Foot Ankle Surgery.2009;15(3):123-6

Kim BS, Choi WJ, Kim YS, Lee JW. Total ankle replacement in moderate to severe varus deformity of the ankle. 2009;91(9):1183-90.

Saltzman CL, Mann RA, Ahrens JE, et al. Prospective controlled trial of STAR total ankle replacement versus ankle fusion: initial results. Foot Ankle Int. 2009;30(7):579-96.

Wood PL, Sutton C, Mishra V, Suneja R. A randomized, controlled trial of two mobile-bearing total ankle replacements. J Bone Joint surg Br. 2009;91(1):69-74.

Gougoulias N, Khanna A, Maffulli N. How successful are current ankle replacements?: a systematic review of the literature. Clin Orthop Relat Res. 2010;468(1):199-208.

Karantana A, Hobson S, Dhar S. The Scandinavian total ankle replacement: survivorship at 5 and 8 years comparable to other series. Clin Orthop Relat Res. 2010;468(4):951-7.

Morgan SS, Brooke B, Harris NJ. Total ankle replacement by the ankle evolution system: medium-term outcome. J Bone Joint Surg Br. 2010;92(1):61-5.

Whalen JL, Spelsberg SC, Murray P. Wound breakdown after total ankle arthroplasty. Foot Ankle Int. 2010;31(4):301-5.

American Orthopaedic Foot and Ankle Society (AOFAS). Position statement on total ankle arthroplasty. August 4, 2009. Available at: www.aofas.org..

Blue Cross Blue Shield Association Medical Policy 7.01.77 (Total Ankle Replacement);September 2009.

InterQual Level of Care Criteria 2010, Acute Care Adult, McKesson Health Solutions, LLC