This document addresses total ankle replacement (arthroplasty) to replace a painful ankle joint. This procedure is indicated for pain due to osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis.
Note: Please see the following related document for additional information:
Total ankle replacement using a U.S. Food and Drug Administration approved device* is considered medically necessary to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis when criteria in A, B, and C below are met:
Revision or replacement of an implanted total ankle replacement is considered medically necessary, using a U.S. Food and Drug Administration approved device*, when the implanted device has failed, and ALL of the criteria outlined above are met, EXCEPT criterion A3 regarding "Completion and failure of at least 6 months of conservative treatment." For replacement or revision, no prior treatment other than previous prosthetic implantation is required.
Investigational and Not Medically Necessary:
Total ankle replacement is considered investigational and not medically necessary when the above criteria are not met and for all other conditions.
*For U.S. Food and Drug Administration approved device, see Rationale section.
Ankle arthrodesis (fusion) has been considered to be the preferred surgical procedure for the treatment of ankle arthritis. However, arthrodesis is not without its disadvantages and limitations. Arthrodesis can limit the motion of the ankle, thereby limiting mobility. During the recovery period following ankle arthrodesis, immobilization is usually required until there are signs of clinical and radiographic fusion (this can last 12 to 20 weeks). Some individuals develop a nonunion and require additional surgery. Adjacent joints may become painful due to the development of arthritis. In May 2009, the U.S. Food and Drug Administration (FDA) approved the Scandinavian Total Ankle Replacement™ (S.T.A.R.) System (Small Bone Innovations, Inc., Morrisville, PA-Small Bone Innovations, Inc. was acquired by Stryker in 2014). Although several other ankle systems have had FDA clearance through the 510(k) process, the S.T.A.R. System is the first approval of an ankle replacement system by the FDA. The researchers followed a group of 224 individuals in a clinical study and found that the ankle replacement system demonstrated similar rates of unfavorable events, surgical interventions and major complications as the alternative of fusion surgery (arthrodesis). With this approval of an ankle replacement system, improvement in prosthesis designs, and longer term outcome studies, total ankle replacement is now being considered as an alternative to ankle arthrodesis for the treatment of ankle arthritis.
Wood (2008) conducted a study of 200 total ankle replacements and reports on the medium-term results, 5 years postoperatively. Of the 200 ankles, 119 individuals had inflammatory arthritis and 81 individuals had osteoarthritis (25 were fracture-related). Using the American Orthopaedic Foot and Ankle Society (AOFAS) ankle and hindfoot scoring tool to assess pain and function, the authors found that 135 ankles (67.5%) had good relief from pain. The 5-year survival rate of the prosthesis was 93.3% and the 10-year survival rate was 80.3%. Overall, 24 ankles failed at a mean of 48 months. Other complications included 5 ankles with delayed wound healing, 9 ankles had an intra-operative malleolar fracture and 10 ankles had a post-operative fracture within the first 12 months following total ankle replacement. The authors concluded that their survivorship figures were similar to those of early reports of total knee replacement when techniques and designs were being developed.
In order to help ensure the success of the total ankle replacement surgery, only certain individuals would be optimal candidates for this procedure. There is debate in the orthopedic community about what constitutes an optimal candidate for total ankle replacement surgery. Older, thin, sedentary individuals with minimal ankle deformity would be considered the optimal candidates. Some authors define older as greater than 50 years of age and thin as weighing less than 200 pounds. However, there is no clear consensus about what defines older, thin or sedentary. Due to the complexity of the ankle replacement procedure and potential for complications, individuals should have reached skeletal maturity, should have moderate or severe ankle pain, loss of mobility and function of the ankle and should have completion of at least 6 months of conservative treatment (Saltzman, 2009). Experience of the surgeon can also be a contributing factor to the success of a total ankle replacement. The overall incidence of adverse events and the need for subsequent surgeries has been reported to decrease with improved technique and greater surgeon experience (Saltzman, 2009).
In 2010, Slobogean and colleagues reported on quality of life 1 year post either ankle arthrodesis or total ankle replacement for end-stage ankle arthritis. A total of 107 individuals prospectively completed a Short-Form-36 (SF-36) generic health-related quality of life instrument and completed it again 1 year following either ankle arthrodesis or total ankle replacement. At baseline, there was no difference in the values between the two groups. At baseline, the health state value for the total ankle replacement group was 0.67 and for the arthrodesis group it was 0.66. At 1 year post surgery, the health state value for the total ankle replacement group was 0.73 and for the arthrodesis group was also 0.73. There was marked increase in both groups from baseline to 1 year post surgery; however, no significant difference between the two treatment groups. This study suggests that those individuals with end-stage ankle arthritis report lower quality of life and surgical treatment either by arthrodesis or ankle replacement may improve reported quality of life. This study is limited by the small number of participants and the inability to account for comorbidities which may affect the reported health state values. Further study is warranted.
In 2011, Zhao and colleagues reported on the outcomes and failure rates of the S.T.A.R. ankle replacement system. Reporting on a total of 16 studies which encompassed 2088 total ankle replacements and a mean follow-up time of 52 months, the 5-year pooled survival rate was 85.9% and the pooled 10-year survival rate was 71.1%. The mean failure rate of the S.T.A.R. implant was 11.1%. The three most common reasons for failure were aseptic loosening, malalignment, and infection. The authors concluded that an increase in surgeon experience and appropriate candidate selection could help to improve outcomes and decrease failure rate.
Malalignment of greater than 15 degrees has been considered to be a contraindication to total ankle replacement. A study by Queen and colleagues (2013) reported on the varying degrees of malalignment and compared the clinical outcomes and physical performance following total ankle replacement surgery. A total of 103 participants had total ankle replacement surgery; 17 of those participants were noted to have a malalignment of greater than 15 degrees preoperatively. Prior to surgery, participants had a clinician's assessment of function and also completed self-reported pain and function questionnaires. The participants completed the questionnaires again at 12 and 24 months following surgery. The authors report no significant differences in the clinical or functional outcomes on the basis of preoperative malalignment. The authors also note that the participants in their study were only followed for 2 years after ankle replacement surgery and "additional studies following patients for more than two years are necessary to understand the influence of preoperative alignment on the longevity of fixed-bearing total ankle implants."
A meta-analysis by Zaidi and colleagues (2013) looked at 58 studies involving 7942 total ankle replacement surgeries. The majority of the studies were level IV studies. The most commonly reported reason for total ankle replacement was post-traumatic arthritis followed by primary arthritis and rheumatoid arthritis. Overall 10-year survival rate of the implant was 89%. The authors reported intrinsic biases in all of the studies reviewed. But at 10 years postoperatively, the AOFAS and visual analog scores reported showed significant improvements.
A small (n=76) prospective study (Kraal, 2013) suggests that at 15 years follow-up, artificial joint survival remains relatively high, at 80% with sustained improvement in AOFAS scores (mean=80.4%, confidence interval [CI], 72-88). In this small cohort study, all devices were mobile-bearing in design and indication for replacement in all participants was inflammatory joint disease, potentially limiting generalizability of the findings.
Another small cohort study by Jastifer and colleagues (2014) published extended long-term data. Artificial joint survival in 18 participants who underwent revision with S.T.A.R. System was evaluated 10-15 years (mean 12.6 years) post-operation. Overall survival was high, at 94.4%, but 39% (n=7) of ankles required additional procedures (most were performed at 9 years or more). AOFAS scores improved from 32.8 preoperatively to 78 at the most recent follow-up and all participants rated their perceived outcome of total ankle replacement as good or excellent. Visual analog scores pain scores were reduced from a mean of 8.1 preoperatively to 2.1 at last follow-up. Although small, this study provides additional support for the longevity of total ankle replacement.
In a large cohort study, Daniels and colleagues (2014) compared intermediate-term results of total ankle replacement to arthrodesis. Of 388 ankles, 321 were available for follow-up at a mean of 5.5 years post-operation (n=232 replacements and n=89 arthrodesis). Authors found that despite higher rates of complication and reoperation rates in the total ankle replacement group, the primary outcomes of interest (Ankle Osteoarthritis Scale [AOS] and SF-36 scores) were equitable between the procedures. Authors highlight the potentially confounding aspect of this study that the arthrodesis group was younger, more likely to smoke and more likely to have diabetes. An additional short-coming was the lack of stratification by device type (six different total ankle replacement systems were used).
A novel prospective study by Jastifer and colleagues (2015) similarly evaluated the performance of total ankle replacement to arthrodesis; however, the focus of their investigation was performance on uneven surfaces, stairs and inclines. In total, 77 ankles received either total ankle replacement (n=61) or arthrodesis (n=16). Clinical and functional status of participants' ankles was evaluated preoperatively and postoperatively at 6 and 12 months. Both groups improved postoperatively from baseline, but the total ankle replacement group performed significantly better at walking up stairs (p=0.013), down stairs (p=0.012), and uphill (p=0.016). Furthermore the AOFAS scores, ankle dorsiflexion and ankle plantar flexion were also better in the total ankle replacement group (p=0.03, p<0.001, and p<0.001, respectively). This is the first study to investigate ankle joint performance of arthroplasty versus arthrodesis on uneven surfaces and stairs. Further investigation in large, diverse populations with long-term follow-up is warranted given the current recommendation that arthrodesis is more appropriate for younger, active individuals.
The American College of Foot and Ankle Surgeons® (ACFAS) updated their position statement on total ankle replacement surgery in July 2013 and they conclude that "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."
In 2014, the AOFAS released the following position statement: "The [AOFAS] endorses the use of total ankle replacement surgery for treatment of arthritic conditions of the ankle and does not consider this procedure to be experimental in select patients with this diagnosis who have failed nonoperative treatment."
Total ankle replacement involves the surgical removal of a dysfunctional and painful ankle joint and its replacement with a prosthetic device. The purpose of a total ankle replacement is to relieve pain and restore joint function in individuals with medically refractory, end-stage degenerative joint disease resulting from conditions such as osteoarthritis, post-traumatic arthritis, or rheumatoid 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. Total ankle replacement has 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. However, researchers have continued to investigate new designs, which can be broadly subdivided into constrained and unconstrained designs. Constrained prostheses offer the advantage of greater stability, but with decreased mobility and increased stress at the bone implant interface, potentially leading to a greater risk of early loosening and failure. Unconstrained designs provide improved range of motion in multiple planes, but at the expense of stability. The first devices investigated were implanted with cement fixation, which in recent years has given way to cementless designs. The main alternative to total ankle replacement is arthrodesis which involves fusing the bones together completely restricting ankle motion. While both procedures are designed to reduce pain, the total ankle replacement is also intended to improve function.
The following outcomes are relevant to the analysis of safety and efficacy of total ankle replacement, compared to ankle arthrodesis, the standard treatment alternative:
For example, if an arthrodesis or ankle replacement is not properly aligned, significant gait abnormalities may result. In addition, an arthrodesis puts additional strain on proximal joints, which may in turn accelerate the development of arthritis in the knee and hip. The principal limitations of past total ankle replacements have been loosening of the prosthesis, requiring revision. If the prosthesis requires removal, the success of a subsequent arthrodesis must be considered. Different prostheses require different amounts of removal of bone stock, potentially compromising the success of a subsequent arthrodesis.
Arthrodesis: The surgical fusion of a joint.
Arthroplasty: A procedure in which a joint is removed and replaced with a prosthesis.
Prosthesis: An artificial device to replace or augment a missing or impaired part of the body.
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
When services may be Medically Necessary when criteria are met:
|27702||Arthroplasty, ankle; with implant (total ankle)|
|27703||Arthroplasty, ankle; revision, total ankle|
|0SRF0J9||Replacement of right ankle joint with synthetic substitute, cemented, open approach|
|0SRF0JA||Replacement of right ankle joint with synthetic substitute, uncemented, open approach|
|0SRF0JZ||Replacement of right ankle joint with synthetic substitute, open approach|
|0SRG0J9||Replacement of left ankle joint with synthetic substitute, cemented, open approach|
|0SRG0JA||Replacement of left ankle joint with synthetic substitute, uncemented, open approach|
|0SRG0JZ||Replacement of left ankle joint with synthetic substitute, open approach|
|0SWF0JZ-0SWFXJZ||Revision of synthetic substitute in right ankle joint [by approach; includes codes 0SWF0JZ, 0SWF3JZ, 0SWF4JZ, 0SWFXJZ]|
|0SWG0JZ-0SWGXJZ||Revision of synthetic substitute in left ankle joint [by approach; includes codes 0SWG0JZ, 0SWG3JZ, 0SWG4JZ, 0SWGXJZ]|
|M05.071-M05.079||Felty's syndrome, ankle and foot|
|M05.171-M05.179||Rheumatoid lung disease with rheumatoid arthritis of ankle and foot|
|M05.271-M05.279||Rheumatoid vasculitis with rheumatoid arthritis of ankle and foot|
|M05.371-M05.379||Rheumatoid heart disease with rheumatoid arthritis of ankle and foot|
|M05.471-M05.479||Rheumatoid myopathy with rheumatoid arthritis of ankle and foot|
|M05.571-M05.579||Rheumatoid polyneuropathy with rheumatoid arthritis of ankle and foot|
|M05.671-M05.679||Rheumatoid arthritis of ankle and foot with involvement of other organs and systems|
|M05.771-M05.779||Rheumatoid arthritis with rheumatoid factor of ankle and foot without organ or systems involvement|
|M05.871-M05.879||Other rheumatoid arthritis with rheumatoid factor of ankle and foot|
|M06.071-M06.079||Rheumatoid arthritis without rheumatoid factor, ankle and foot|
|M06.871-M06.879||Other specified rheumatoid arthritis, ankle and foot|
|M08.071-M08.079||Unspecified juvenile rheumatoid arthritis, ankle and foot|
|M08.271-M08.279||Juvenile rheumatoid arthritis with systemic onset, ankle and foot|
|M08.471-M08.479||Pauciarticular juvenile rheumatoid arthritis, ankle and foot|
|M08.871-M08.879||Other juvenile arthritis, ankle and foot|
|M08.971-M08.979||Juvenile arthritis, unspecified|
|M12.571-M12.579||Traumatic arthropathy, ankle and foot|
|M12.871-M12.879||Other specific arthropathies, not elsewhere classified, ankle and foot|
|M13.171-M13.179||Monoarhtritis, not elsewhere classified, ankle and foot|
|M13.871-M13.879||Other specified arthritis, ankle and foot|
|M15.0||Primary generalized (osteo)arthritis|
|M15.3||Secondary multiple arthritis|
|M19.071-M19.079||Primary osteoarthritis ankle and foot|
|M19.171-M19.179||Post-traumatic osteoarthritis, ankle and foot|
|M19.271-M19.279||Secondary osteoarthritis, ankle and foot|
|M25.571-M25.579||Pain in ankle|
|T84.018A-T84.018S||Broken internal joint prosthesis [when specified as ankle]|
|T84.028A-T84.028S||Dislocation of other internal joint prosthesis [when specified as ankle]|
|T84.038A-T84.038S||Mechanical loosening of other internal prosthetic joint [when specified as ankle]|
|T84.068A-T84.068S||Wear of articular bearing surface of internal prosthetic joint [when specified as ankle]|
|T84.098A-T84.098S||Other mechanical complication of other internal joint prosthesis [when specified as ankle]|
|Z96.661-Z96.669||Presence of artificial ankle joint|
When services are Investigational and Not Medically Necessary:
For the procedure codes listed above when criteria are not met, for all other diagnoses not listed, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Websites for Additional Information|
Agility® LP Total Ankle System
INBONE® Total Ankle System
SALTO Talaris® Total Ankle Prosthesis
STAR Total Ankle Replacement System
Total Ankle Replacement
Zimmer® Trabecular Metal™ Total Ankle
The use of specific product names is illustrative 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.
|Revised||05/04/2017||Medical Policy & Technology Assessment Committee (MPTAC) review. Minor typographical change in the Position Statement. Updated Rationale and Reference sections.|
|Revised||05/05/2016||MPTAC review. Updated References. Removed ICD-9 codes from Coding section.|
|Revised||05/07/2015||MPTAC review. Clarified medically necessary statement regarding revision or replacement of a previously implanted prosthesis. Updated References.|
|Reviewed||02/05/2015||MPTAC review. Updated Rationale and References sections.|
|Reviewed||02/13/2014||MPTAC review. Updated Rationale and References.|
|Revised||02/14/2013||MPTAC review. Clarification to Position Statement. Updated Rationale, References, and Index.|
|Revised||02/16/2012||MPTAC review. Clarification of Position Statement. Updated Rationale, Definitions, References and Index.|
|Reviewed||05/19/2011||MPTAC review. Updated Rationale, References and Index.|
|Revised||05/13/2010||MPTAC review. Addition to medically necessary statement about revision or replacement. Updated Coding and References.|
|Revised||11/19/2009||MPTAC review. Added medically necessary criteria for FDA approved device. Updated Rationale, Coding, References and Web Sites.|
|06/03/2009||Updated Rationale to include FDA approval of total ankle replacement system.|
|Reviewed||11/20/2008||MPTAC review. References, Coding, Rationale and Background/Overview sections updated.|
|Reviewed||11/29/2007||MPTAC review. References, Rationale and Background/Overview sections updated. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary."|
|Reviewed||12/07/2006||MPTAC review. Rationale and References updated.|
|Reviewed||09/14/2006||MPTAC review. References updated.|
|Revised||09/22/2005||MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.|
|Pre-Merger Organizations||Last Review Date||Document Number||Title|
|Anthem Southeast||11/08/2004||Memo 1179||Total Ankle Replacement|
|WellPoint Health Networks, Inc.||1/04/2004||3.01.13||Total Ankle Replacement|