Latest Review Date: June 2024

Category:  Surgery                                                                 

POLICY

Total ankle replacement using an FDA-approved device may be considered medically necessary in skeletally mature patients with moderate to severe ankle (tibiotalar) pain that limits daily activity and who have the following conditions:

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

AND absence of the following contraindications:

• Extensive avascular necrosis of the talar dome;
• Compromised bone stock or soft tissue (including skin and muscle);
• Severe malalignment (e.g., > 15 degrees) not correctable by surgery;
• Active ankle joint infection;
• Peripheral vascular disease;
• Charcot neuroarthropathy.
• Peripheral neuropathy;
• Ligamentous instability;
• Subluxation of the talus;
• History of ankle joint infection;
• Presence of severe deformities above or beneath the ankle.

Revision or replacement of an implanted total ankle prosthesis may be considered medically necessary for failure of a previously implanted ankle prosthesis (e.g., implant loosening, malpositioning, periprosthetic, infection, or periprosthetic fracture).

DESCRIPTION OF PROCEDURE OR SERVICE

A variety of total ankle replacement (TAR) system designs, including fixed-bearing and mobile-bearing, are being investigated for the management of moderate-to-severe tibiotalar pain. TAR (arthroplasty) is being evaluated as an alternative to tibiotalar fusion (arthrodesis) in patients with arthritis.

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. The main alternative to total ankle replacement is arthrodesis. While both procedures are designed to reduce pain, the total ankle replacement is also intended to improve function and reduce stress on adjacent joints. TAR has been investigated since the 1970s, 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. More than twenty different ankle replacement systems are currently being evaluated worldwide.

Total ankle replacement has been performed in patients with severe rheumatoid arthritis, severe osteoarthritis, or post-traumatic osteoarthrosis. In general, patients selected for arthroplasty would not be good candidates for arthrodesis due to the presence of bilateral or subtalar arthritis or Chopart arthrosis. Optimal candidates for total ankle replacement are considered to be older (age > 50), thin, low-demand individuals with minimal deformity.  Patients should have no functional barriers to participation in a rehabilitation program.

KEY POINTS

Summary of Evidence

The established standard for the painful arthritic ankle is fusion, which usually results in a pain-free but rigid ankle in the short term. Complications associated with ankle fusion are non-union, an increase in arthrosis, and pain in adjoining joints, and not uncommonly, amputation. For specific conditions, including presence of bilateral, subtalar or midfoot arthritis, fusion is not indicated. Therefore, in the absence of an established alternative for specific conditions, total ankle replacement may be considered medically necessary when those specified conditions are met.

Practice Guidelines and Position Statements

American Orthopaedic Foot and Ankle Society (AOFAS)

The AOFAS Position Statement on The Use of Total Ankle Replacement for the Treatment of Arthritic Conditions of the Ankle (approved April 2018) concludes “Ankle arthritis is a condition that can result in substantial pain and dysfunction. The American Orthopaedic Foot & Ankle Society supports the use of total ankle replacement as an option for the treatment of ankle arthritis that has failed conservative management in select patients due to its demonstrated improved outcomes in multiple peer reviewed publications.”

American College of Foot and Ankle Surgeons (ACFAS)

The ACFAS Position Statement on Total Ankle Replacement Surgery (February 2020) notes that not every patient with end-stage arthritis of the ankle is a sound candidate for ankle replacement. A surgeon experienced in total ankle surgery can make this determination through careful history and physical evaluation. In the United States, total ankle replacement surgery is currently a safe and effective treatment option for select patients with end stage ankle arthritis. Studies have shown total ankle replacement surgery improves patient function, reduces pain, and promotes improved quality of life.

American Academy of Orthopaedic Surgeons (AAOS)

AAOS published a 2010 technology overview of surgical treatment options for patients with ankle arthritis in whom nonoperative treatment has failed. The report concluded that based on low- and very low-quality evidence, treatment of ankle arthritis with either a Generation 2 or Generation 3 total ankle arthroplasty results in an improvement in pain and function. The literature does not conclusively demonstrate predictors of better or worse patient-oriented outcomes (e.g., device failure, reoperation, pain relief, patient satisfaction, walking ability) for total ankle arthroplasty.

Additionally, the report concluded that there is limited data from multiple studies directly comparing the efficacy of total ankle arthroplasty to arthrodesis in patients with arthritis. The disparate preoperative ankle function scores and demographic characteristics between the groups enrolled in the relevant comparative studies prohibit meaningful comparisons and confound the interpretation of the data. Analysis of adverse events that corrected for preoperative differences in patients characteristics, provide conflicting results.

National Institute for Health and Clinical Excellence (NICE)

NICE considers total ankle replacement surgery standard clinical practice with an efficacy and safety profile that is sufficiently well-known.

KEY WORDS

Agility ankle, ankle replacement, total ankle arthroplasty, ankle, total ankle replacement, ankle arthrodesis

APPROVED BY GOVERNING BODIES

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.  In 2002, the U.S. Food and Drug Administration (FDA) approved the Agility® Ankle Revision Prosthesis (DePuy Orthopaedics), which is intended for cemented use only in patients with a failed previous ankle surgery. In 2005, the FDA reviewed a 510(k) marketing clearance application for the Topez™ Total Ankle Replacement (Topez Orthopedics, Inc., Boulder, Colorado) and determined that it was substantially equivalent to the existing DePuy Agility device.  The Topez Ankle is now called the InBone™ Total Ankle System (Wright Medical Technology, Arlington, TN).  This device is also intended for cemented use only. The Agility LP (DePuy Orthopaedics) and the Eclipse (Kinetikos Medical, Carlsbad, CA) received 510(k) marketing clearance in 2006.  The SALTO Talaris® (Tornier, Edina, MN) received 510(k) marketing clearance in 2006 and 2009. These semi-constrained cemented prostheses are indicated in patients with end-stage ankle disorders (e.g., affected with severe rheumatoid, post-traumatic, or degenerative arthritis) as an alternative to ankle fusion.

Three-piece mobile-bearing systems have a polyethylene component that is unattached and articulates independently with both the tibial and talar components.  The three-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 and have a porous coating on the components to encourage osseointegration.  They include the Ankle Evolution System (AES, Biomet, Whippany, NJ), Buechel- Pappas system, HINTEGRA® Total Ankle Prosthesis (New Deal), Mobility™ Total Ankle System (DePuy), Salto Total Ankle Prosthesis (Tornier), Scandinavian Total Ankle Replacement (STAR, Small Bone Innovations, Morrisville, PA), Bologna and Oxford Universities (BOX) Ankle (MAT Ortho), CCI Evolution Ankle (Van Straten), Zenith (Corin) and the TNK ankle (Kyocera Corporation, Kyoto, Japan). Three-component mobile-bearing systems are Class III devices and are considered under a different regulatory pathway (premarket approval) than the fixed component devices described above, which were cleared for marketing under the 510(k) regulatory pathway. Premarket approval (PMA) requires demonstration of clinical efficacy in FDA-regulated trials conducted under an investigational device exemption (IDE). In May 2009, the FDA approved the STAR ankle as an alternative to fusion for replacing an ankle joint deformed by rheumatoid arthritis, primary arthritis, or post-traumatic arthritis. As a condition of the approval, the device maker must evaluate the safety and effectiveness of the device over the next eight years.  The Mobility™ Total Ankle System is currently being evaluated in a FDA-regulated investigational device exemption (IDE) trial.  The Ankle Evolution System (AES), Buechel-Pappas, Mobility, Salto Total Ankle, BOX Ankle, CCI Evolution Ankle, Zenith, and the TNK ankle are not currently used in the United States.

BENEFIT APPLICATION

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING 

CPT Codes:

REFERENCES

1. Adukia V, Mangwani J, Issac R, Hussain S, Parker L. Current concepts in the management of ankle arthritis. J Clin Orthop Trauma. 2020 May-Jun;11(3):388-398.
2. Agility-Ankle Revision Prosthesis 510(k) Summary.  www.fda.gov/cdrh/pdf2/k020541.pdf.
3. American Academy of Orthopaedic Surgeons (AAOS). Technology Overview. The surgical treatment of ankle arthritis. 2010. www.aaos.org/research/overviews/AnkleArthritis_surgical.pdf.
4. American College of Foot and Ankle Surgeons (ACFAS). Position Statement on Total Ankle Replacement Surgery. February 2020. www.acfas.org/Health-Policy-and-Advocacy/Policy-Statements/Position-Statements/
5. American Orthopaedic Foot & Ankle Society (AOFAS). Position Statement: The Use of Total Ankle Replacement for the Treatment of Arthritic Conditions of the Ankle. July 2022. www.aofas.org/docs/default-source/research-and-policy/position-statements/total-ankle-replacement-position-statement.pdf?sfvrsn=9a9512c7_6
6. Demetracopoulos CA, Cody EA, Adams SB Jr, DeOrio JK, Nunley JA et al. Outcomes of Total Ankle Arthroplasty in Moderate and Severe Valgus Deformity. Foot Ankle Spec. 2019 Jun;12(3):238-245.
7. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
8. Jeyaseelan L, Si-Hyeong Park S, Al-Rumaih H, Veljkovic A, Penner MJ, et al. Outcomes Following Total Ankle Arthroplasty: A Review of the Registry Data and Current Literature. Orthop Clin North Am. 2019 Oct;50(4):539-548.
9. Kanzaki N, Chinzei N, Yamamoto T, Yamashita T, Ibaraki K, Kuroda R. Clinical Outcomes of Total Ankle Arthroplasty With Total Talar Prosthesis. Foot Ankle Int. 2019 Aug;40(8):948-954.
10. Kim HJ, Suh DH, Yang JH, Lee JW, Kim HJ, et al. Total ankle arthroplasty versus ankle arthrodesis for the treatment of end-stage ankle arthritis: a meta-analysis of comparative studies. Int Orthop. 2017 Jan;41(1):101-109.
11. Koo K, Liddle AD, Pastides PS, Rosenfeld PF. The Salto total ankle arthroplasty - Clinical and radiological outcomes at five years. Foot Ankle Surg. 2019 Aug;25(4):523-528.
12. Kurokawa H, Taniguchi A, Morita S, Takakura Y, Tanaka Y. Total ankle arthroplasty incorporating a total talar prosthesis: a comparative study against the standard total ankle arthroplasty. Bone Joint J. 2019 Apr;101-B(4):443-446.
13. Lee GW, Seon JK, Kim NS, Lee KB. Comparison of intermediate-term outcomes of total ankle arthroplasty in patients younger and older than 55 years. Foot Ankle Int. 2019;40(7):762-768.
14. Marks RM. Mid-Term Prospective Clinical and Radiographic Outcomes of a Modern Fixed-Bearing Total Ankle Arthroplasty. J Foot Ankle Surg. 2019 Nov;58(6):1163-1170.
15. Mehdi N, Bernasconi A, Laborde J, Lintz F. Comparison of 25 ankle arthrodeses and 25 replacements at 67 months' follow-up. Orthop Traumatol Surg Res. 2019 Feb;105(1):139-144.
16. Merrill RK, Ferrandino RM, Hoffman R, Ndu A, Shaffer GW. Comparing 30-day all-cause readmission rates between tibiotalar fusion and total ankle replacement. Foot Ankle Surg. 2019 Jun;25(3):327-331.
17. Norvell DC, Ledoux WR, Shofer JB, Hansen ST, Davitt J, et al. Effectiveness and Safety of Ankle Arthrodesis Versus Arthroplasty: A Prospective Multicenter Study. J Bone Joint Surg Am. 2019 Aug 21;101(16):1485-1494.
18. Nunley JA, Adams SB, Easley ME, DeOrio JK. Prospective Randomized Trial Comparing MobileBearing and Fixed-Bearing Total Ankle Replacement. Foot Ankle Int. 2019 Nov;40(11):1239-1248.
19. Onggo JR, Nambiar M, Phan K, Hickey B, Galvin M, Bedi H. Outcome after total ankle arthroplasty with a minimum of five years follow-up: A systematic review and meta-analysis. Foot Ankle Surg. 2019 Jul 25. pii: S1268-7731(19)30111-0. [Epub ahead of print]
20. Palanca A, Mann RA, Mann JA, Haskell A. Scandinavian Total Ankle Replacement: 15-Year Follow-up. Foot Ankle Int. 2018 Feb;39(2):135-142.
21. Segal AD, Cyr KM, Stender CJ, Whittaker EC, Hahn ME, et al. A three-year prospective comparative gait study between patients with ankle arthrodesis and arthroplasty. Clin Biomech (Bristol, Avon). 2018 May;54:42-53.
22. Shane A, Sahli H. Total Ankle Replacement Options. Clin Podiatr Med Surg. 2019 Oct;36(4):597-607.
23. Stadler C, Stobich M, Ruhs B, et al. Intermediate to long-term clinical outcomes and survival analysis of the Salto Mobile Bearing total ankle prothesis. Arch Orthop Trauma Surg. 2021 Jun 4 [Online ahead of print].
24. van der Plaat LW, Haverkamp D. Patient selection for total ankle arthroplasty. Orthop Res Rev. 2017 Jul 31;9:63-73.
25. Veljkovic AN, Daniels TR, Glazebrook MA, Dryden PJ, Penner MJ, et al. Outcomes of Total Ankle Replacement, Arthroscopic Ankle Arthrodesis, and Open Ankle Arthrodesis for Isolated Non-Deformed End-Stage Ankle Arthritis. J Bone Joint Surg Am. 2019 Sep 4;101(17):1523-1529.

POLICY HISTORY

Medical Policy Group, January 2009 (3)

Medical Policy Administration Committee, February 2009

Medical Policy Group, April 2009

Medical Policy Group, September 2009 (3)

Medical Policy Administration Committee, September 2009

Available for comment September 18-November 2, 2009

Medical Policy Group, November 2009 (3)

Medical Policy Administration Committee, November 2009

Medical Policy Group, October 2010

Medical Policy Group, October 2011; (3): Updated Description, Key Points & References

Medical Policy Group, April 2012 (2): 2012 Update-updated Key Points and References

Medical Policy Group, November 2012 (3): Additional 2012 Update to Description, Key Points and References

Medical Policy Panel, August 2013

Medical Policy Group, August 2013 (3):  2013 Updated to Description, Key Points and References; no change in policy statement

Medical Policy Group, October 2013 (3): Removed ICD-9 Procedure codes; no change in policy statement.

Medical Policy Panel, July 2014

Medical Policy Group, July 2014 (3): 2014 Updates to Description & References; no change in policy statement  Policy retired.

Medical Policy Group, October 2019 (7): Reviewed by consensus. Policy Statement clarified. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, June 2021 (7): Reviewed by consensus. Updates to Key Points and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, June 2022 (7): Reviewed by consensus. Updates to Key Points and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, June 2023 (7): Reviewed by consensus. Updates to Benefit Application and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, June 2024 (7): Reviewed by consensus. Updates to References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.