Clinical UM Guideline

 

Subject: Total Ankle Replacement
Guideline #: CG-SURG-74 Publish Date:    06/28/2018
Status: New Last Review Date:    03/22/2018

Description

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:

Clinical Indications

Medically Necessary:

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:

  1. All of the following clinical features are present:
    1. Skeletally mature individual; and
    2. Ankle pain that significantly limits daily activity; and
    3. Completion and failure of at least 6 months of conservative treatment (such as anti-inflammatory medication, physical therapy, splints or orthotic devices as indicated);
      AND
  2. At least 1 of the following clinical conditions are present:
    1. Arthritis in adjacent joints (that is, subtalar or midfoot); or
    2. Arthrodesis of the contralateral ankle; or
    3. Inflammatory (for example, rheumatoid) arthritis; or
    4. Severe arthritis of the contralateral ankle;
      AND
  3. None of the following contraindications to total ankle replacement are present:
    1. Active ankle joint infection
    2. Charcot neuropathy
    3. Compromised bone stock or soft tissue
    4. Extensive avascular necrosis of the talar dome
    5. Malalignment (such as varus or valgus deformity greater than 15 degrees) not correctable by surgery
    6. Peripheral vascular disease

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.

Not Medically Necessary:

Total ankle replacement is considered not medically necessary when the above criteria are not met and for all other conditions.

*For U.S. Food and Drug Administration approved device explanation, see Discussion/General Information section.

Coding

The following codes for treatments and procedures applicable to this guideline 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.

CPT

 

27702

Arthroplasty, ankle; with implant (total ankle)

27703

Arthroplasty, ankle; revision, total ankle

 

 

ICD-10 Procedure

 

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]

 

 

ICD-10 Diagnosis

 

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

M13.0

Polyarthritis, unspecified

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

Discussion/General Information

Total ankle replacement (also known as an ankle arthroplasty) 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. However, 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. Since then, researchers have continued to investigate new designs that can be broadly subdivided into constrained and unconstrained designs. Constrained prostheses offer the advantage of greater stability, but they can also cause 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 standard alternative to total ankle replacement is ankle arthrodesis (also known as an ankle fusion) that involves fusing the bones together completely, restricting ankle motion. 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 addition, an arthrodesis puts additional strain on proximal joints, which may in turn accelerate the development of arthritis in the knee and hip.

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 principal limitations of past total ankle replacements have been the loosening of the prosthesis, which requires 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. If an arthrodesis or ankle replacement is not properly aligned, significant gait abnormalities may result.

The first U.S. Food and Drug Administration (FDA) approved total ankle prosthetic device is the Scandinavian Total Ankle Replacement (STAR) system (Stryker, Mahwah, NJ), which was approved in May 2009. Researchers followed a group of 224 individuals in a clinical study and found that the STAR system demonstrated similar rates of unfavorable events, surgical interventions, and major complications as the alternative of arthrodesis. With this approval of an ankle replacement system, improvement in prosthesis design, and longer-term outcome studies, total ankle replacement is now being considered as an alternative to ankle arthrodesis for the treatment of ankle arthritis. Since the STAR system was approved, the FDA has approved several devices through the 510(k) process including, but not limited to, the INBONE® Total Ankle System (Wright Medical Technology, Memphis, TN) and the Salto Talaris® Total Ankle Prosthesis (Integra LifeSciences, Plainsboro, NJ).

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 that had an intra-operative malleolar fracture, and 10 ankles that 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, have moderate or severe ankle pain, loss of mobility and function of the ankle, and 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 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 suggested that those individuals with end-stage ankle arthritis reported lower quality-of-life, and surgical treatment, either by arthrodesis or ankle replacement, may improve reported quality-of-life. This study was limited by the small number of participants and the inability to account for comorbidities that 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 STAR 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 STAR. 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.

Brunner and colleagues (2013) performed a small study to determine the long-term survivorship of the STAR system. After observing 79 ankles in 72 subjects, the researchers found that 38% had a revision of at least 1 metal component. The implant survival rate was 70.7% at ten years and 45.6% at 14 years. The reasons for revision included aseptic loosening, subsidence of the talar component, and progressive cyst formation. There was a 76% rate of residual pain at the last follow-up; however, most subjects reported satisfaction with the results. Limitations of the study included a small sample size and loss to follow-up.

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 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 significant improvements.

A small (n=76) prospective study (Kraal, 2013) suggested that at 15 years follow-up, artificial joint survival remains relatively high at 80%, with a 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 indications for replacement in all participants was inflammatory joint disease, potentially limiting generalizability of the findings.

A small cohort study by Jastifer and colleagues (2014) published extended long-term data. Artificial joint survival in 18 participants who underwent revision with STAR. 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 in 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 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.

In a retrospective observational study, Pedowitz and colleagues (2016) compared sagittal plane movement for individuals who underwent total ankle arthroplasty (n=41) versus tibiotalar arthrodesis (n=27). Data was collected using radiological assessment and questionnaires (SF-12 2.0, visual analogue scale for pain [VAS], and the Foot and Ankle Ability Measure [FAAM]). The researchers found that the arthroplasty group maintained a greater mean overall sagittal movement (34.2º; 17º to 52.90º) compared to the arthrodesis group (24.3º; 6.9º to 32.4º; p<0.001). In addition, the mean movement across the midfoot was better in the arthroplasty group (p<0.001). The VAS score was a mean of 12.84 mm lower for the arthroplasty goup (p=0.01) while the FAAM score was 10.52 points higher (p=0.01). The authors concluded that total ankle arthroplasty “preserves more anatomic sagittal plane motion and provides greater pain relief and better patient-perceived outcomes compared with ankle arthrodesis.” Limitations of the study included possible bias and confounding due to the retrospective design. The authors noted that the measurement results were static, and further studies are needed to see if the results translate into improved walking ability.

Maffulli and colleagues (2017) performed a systematic review to compare total ankle arthroplasty to arthrodesis for end-stage ankle osteoarthritis. The authors included 21 studies and 32,422 procedures from 1988 to 2017 that had a minimum 6-month follow-up. They found that arthroplasty effectively relieves pain and restores function; however, it has a higher revision rate (20.5%) than arthrodesis (10.3%) (odds ratio [OR] 2.28; 95% CI, 1.63 to 3.19; p<0.0001). The authors concluded:

When considering other treatment options, TAR [total ankle replacement] is an attractive alternative given the theoretical benefit of motion preservation. However, because of the paucity of long-term data, there is insufficient evidence to recommend total ankle replacement over arthrodesis for all patients at this time. Proper patient selection is critical for successful treatment of end-stage ankle OA [osteoarthritis].

In a 2017 meta-analysis, Kim and colleagues compared total ankle arthroplasty to arthrodesis for the treatment of end-stage ankle arthritis. The authors included 10 studies from 2007 to 2015, and the primary outcome was post-operative clinical scores (AOFAS, SF-36, VAS for pain) and the rate of satisfaction. The authors did not find a significant difference between the arthroplasty group and arthrodesis group for the AOFAS score (mean difference [MD] 7.34; 95 % CI, −1.79 to 16.48; p=0.12). Likewise, there were no significant differences for SF-36 scores, the VAS pain score, and the rate of satisfaction. However, the risk of reoperation for the arthroplasty group was significantly higher (RR 1.81; 95 % CI, 1.37 to 2.39; p<0.001), as was the risk of major surgical complications (RR 2.25; 95 % CI, 1.16 to 4.36; p=0.02). The authors concluded that clinical outcomes for total ankle arthroplasty are the same as for arthrodesis. Limitations of the study included a lack of RCTs, heterogeneity among studies, the diversity of prosthesis devices used, the variety of clinical scoring systems used, and the variable follow-up periods. The authors recommend further high-quality studies with long-term follow-up.

Lawton and colleagues (2017) examined the 10-year outcomes of third-generation total ankle arthroplasty compared to arthrodesis. The authors analyzed pooled data from 2006 to 2016, including 200 arthoplasties and 80 arthrodesis procedures. The overall complication, revision, and reoperation rate for arthroplasty was 19.7%, 7.9%, and 9.5%, respectively, compared to 26.9%, 5.4%, 12.9% for arthrodesis, respectively. The most common complications of arthroplasty were aseptic loosening (5.8%), wound complications (5.4%), fracture (4.9%), and deep infection (0.9%). The most common complications of arthrodesis were wound complications (9.8%), nonunion (7.9%), deep infection (3.6%), and fracture (0.8%). Participants who underwent arthroplasty had a more symmetric gait than those who had arthrodesis. The authors concluded that even though arthrodesis had a higher complication rate, arthroplasty had a higher revision rate. They stated that the decision on which method to use “should be made on a case-by-case basis, accounting for appropriate patient selection, discussions regarding pros and cons of each treatment choice, and knowledge of perioperative complication profiles with each procedure.” Limitations of the study included a lack of RCTs, heterogeneity among the available studies, and a variation in reporting methods.

In 2014, the American Orthopaedic Foot and Ankle Society (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.”

The American College of Foot and Ankle Surgeons (ACFAS) updated their position statement on total ankle replacement surgery in July 2016, and they concluded 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.”

Definitions

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.

References

Peer Reviewed Publications:

  1. Anderson T, Montgomery F, Carlsson A. Uncemented STAR total ankle prosthesis. Three to eight-year follow-up of fifty-one consecutive ankles. J Bone Joint Surg Am. 2003; 85-A(7):1321-1329.
  2. Brunner S, Barg A, Knupp M, et al. The Scandinavian total ankle replacement: long-term, eleven to fifteen-year, survivorship analysis of the prosthesis in seventy-two consecutive patients. J Bone Joint Surg Am. 2013; 95(8):711-718.
  3. Colman AB, Pomeroy GC. Transfibular ankle arthrodesis with rigid internal fixation: an assessment of outcome. Foot Ankle Int. 2007; 28(3):303-307.
  4. Conti SF, Wong YS. Complications of total ankle replacement. Foot Ankle Clin. 2002; 7(4):791-807, vii.
  5. Daniels TR, Younger AS, Penner M, et al. Intermediate-term results of total ankle replacement and ankle arthrodesis: a COFAS multicenter study. J Bone Joint Surg Am. 2014; 96(2):135-142.
  6. Dyrby C, Chou LB, Andriacchi TP, Mann RA. Functional evaluation of the Scandinavian total ankle replacement. Foot Ankle Int. 2004; 25(6):377-381.
  7. Easley ME, Vertullo CJ, Urban WC, Nunley JA. Total ankle arthroplasty. J Am Acad Orthop Surg. 2002; 10(3):157-167.
  8. Gill LH. Challenges in total ankle arthroplasty. Foot Ankle Int. 2004; 25(4):195-207.
  9. Guyer AJ, Richardson G. Current concepts review: total ankle arthroplasty. Foot Ankle Int. 2008; 29(2):256-264.
  10. Hintermann B, Valderrabano V. Total ankle replacement. Foot Ankle Clin. 2003; 8(2):375-405.
  11. Hopgood P, Kumar R, Wood PL. Ankle arthrodesis for failed total ankle replacement. 2006; 88(8):1032-1038.
  12. Jastifer JR, Coughlin MJ. Long-term follow-up of mobile bearing total ankle arthroplasty in the United States. Foot Ankle Int. 2015; 36(2):143-150.
  13. Jastifer J, Coughlin MJ, Hirose C. Performance of total ankle arthroplasty and ankle arthrodesis on uneven surfaces, stairs, and inclines: a prospective study. Foot Ankle Int. 2015; 36(1):11-17.
  14. Kim HJ, Suh DH, Yang JH, 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; 41(1):101-109.
  15. Kotnis R, Pasapula C, Anwar F, et al. The management of failed ankle replacement. J Bone Joint Surg Br. 2006; 88(8):1039-1047.
  16. Kraal T, van der Heide HJ, van Poppel BJ, et al. Long-term follow-up of mobile-bearing total ankle replacement in patients with inflammatory joint disease. Bone Joint J. 2013; 95-B(12):1656-1661.
  17. Lawton CD, Butler BA, Dekker RG 2nd, et al. Total ankle arthroplasty versus ankle arthrodesis-a comparison of outcomes over the last decade. J Orthop Surg Res. 2017; 12(1):76.
  18. Maffulli N, Longo UG, Locher J, et al. Outcome of ankle arthrodesis and ankle prosthesis: a review of the current status. Br Med Bull. 2017; 124(1):91-112.
  19. Morse KR, Flemister AS, Baumhauer JF, DiGiovanni BF. Distraction arthroplasty. Foot Ankle Clin. 2007; 12(1):29-39.
  20. Pedowitz DI, Kane JM, Smith GM, et al. Total ankle arthroplasty versus ankle arthrodesis: a comparative analysis of arc of movement and functional outcomes. Bone Joint J. 2016; 98-B(5):634-640.
  21. Queen RM, Adams SB Jr, Viens NA, et al. Differences in outcomes following total ankle replacement in patients with neutral alignment compared with tibiotalar joint malalignment. J Bone Joint Surg Am. 2013; 95(21):1927-1934.
  22. 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):579-596.
  23. Slobogean GP, Younger A, Apostle KL, et al. Preference-based quality of life of end-stage ankle arthritis treated with arthroplasty or arthrodesis. Foot Ankle Int. 2010; 31(7):563-566.
  24. Smith R, Wood PL. Arthrodesis of the ankle in the presence of a large deformity in the coronal plane. J Bone Joint Surg Br. 2007; 89(5):615-619.
  25. SooHoo NF, Zingmond DS, Ko CY. Comparison of reoperation rates following ankle arthrodesis and total ankle arthroplasty. J Bone Joint Surg Am. 2007; 89(10):2143-2149.
  26. Spirt AA, Assal M, Hansen ST Jr. Complications and failure after total ankle arthroplasty. J Bone Joint Surg Am. 2004; 86-A(6):1172-1178.
  27. Stamatis ED, Myerson MS. How to avoid specific complications of total ankle replacement. Foot Ankle Clin. 2002; 7(4):765-789.
  28. Stengel D, Bauwens K, Ekkernkamp A, Cramer J. Efficacy to total ankle replacement with meniscal-bearing devices: a systemic review and meta-analysis. Arch Orthop Trauma Surg. 2005; 125(2):109-119.
  29. Vickerstaff JA, Miles AW, Cunningham JL. A brief history of total ankle replacement and a review of the current status. Med Eng Phys. 2007; 29(10):1056-1064.
  30. Wood PL, Deakin S. Total ankle replacement. The results in 200 ankles. J Bone Joint Surg Br. 2003; 85(3):334-341.
  31. 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):605-609.
  32. Zaidi R, Cro S, Gurusamy K, et al. The outcome of total ankle replacement: a systematic review and meta-analysis. Bone Joint J. 2013; 95-B(11):1500-1507.
  33. Zhao H, Yang Y, Yu G, Zhou J. A systematic review of outcome and failure rate of uncemented Scandinavian total ankle replacement. Int Orthop. 2011; 35(12):1751-1758.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American College of Foot and Ankle Surgeons. Position statement: total ankle replacement surgery. July 2016. Available at: http://www.acfas.org/Health-Policy-and-Advocacy/Policy-Statements/Position-Statements/. Accessed on February 23, 2018.
  2. American Orthopaedic Foot & Ankle Society. Position statement: the use of total ankle replacement for the treatment of arthritic conditions of the ankle. March 2014. Available at: http://www.aofas.org/medical-community/health-policy/Documents/Total-Ankle-Replacement-Position-Statement-3-2014-FINAL.pdf. Accessed on February 23, 2018.
  3. STAR Total Ankle Replacement System [Product Information], Morrisville, PA. Small Bone Innovations. Updated on September 18, 2008. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050050c.pdf. Accessed on February 23, 2018.
  4. U.S. Food and Drug Administration Premarket Approvals. Scandinavian Total Ankle Replacement System (STAR Ankle). P050050. Rockville, MD: FDA. May 29, 2009. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050050a.pdf. Accessed on February 23, 2018.
Websites for Additional Information
  1. National Institutes of Health (NIH), Medline Plus. Ankle Replacement. Updated on March 9, 2017. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/007254.htm. Accessed on February 23, 2018.
Index

Agility® LP Total Ankle System
Ankle Arthroplasty
Ankle Replacement
Eclipse Total Ankle Implant
Hintermann Series H2 Total Ankle System
INBONE Total Ankle System
Infinity® Total Ankle System
Integra® Cadence® Total Ankle Replacement System
Invision Total Ankle Revision System
Salto Talaris Total Ankle Prosthesis
STAR Total Ankle Replacement System
Total Ankle Replacement
Vantage® Total Ankle System
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.

History

Status

Date

Action

New

03/22/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. Initial document development. Moved content of SURG.00081 Total Ankle Replacement to new clinical utilization management guideline document with the same title.