SURG.00081 Total Ankle Replacement



|[pic] |Medical Policy |

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|Subject: |Total Ankle Replacement |

|Policy #:   |SURG.00081 |Current Effective Date:   |07/07/2010 |

|Status: |Revised |Last Review Date:   |05/13/2010 |

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|Description/Scope |

This document addresses total ankle replacement (arthroplasty).

|Position Statement |

Medically Necessary:

Total ankle replacement using an FDA approved device* is considered medically necessary when all of the criteria in Group A are met, and one of the criteria in Group B is met, and none of the conditions in Group C are present:

Group A (ALL 3 of the following):

• Skeletally mature individual; and

• Ankle pain that significantly limits daily activity; and

• 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

Group B (at least 1 of the following):

• Arthritis in adjacent joints (i.e., subtalar or midfoot); or

• Arthrodesis of the contralateral ankle; or

• Inflammatory (e.g., rheumatoid) arthritis; or

• Severe arthritis of the contralateral ankle.

Group C (NONE of the following):

• Active ankle joint infection

• Charcot neuropathy

• Compromised bone stock or soft tissue

• Extensive avascular necrosis of the talar dome

• Malalignment (such as varus or valgus deformity greater than 15 degrees) not correctable by surgery

• Peripheral vascular disease

Revision or replacement of an implanted total ankle replacement is considered medically necessary, using an FDA approved device*, when the implanted device has failed, and the criteria outlined above are met (i.e., all 3 in Group A, at least 1 in Group B, and none of the exclusionary criteria in Group C are present).

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 FDA approved device, see Rationale section.

|Rationale |

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). 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.

Until recently, there has been inadequate data available on total ankle replacements to permit conclusions regarding their safety and effectiveness. Larger studies with longer-term outcomes are being reported. Wood (2008) conducted a study of 200 total ankle replacements and reports on the medium-term results five years postoperatively. Of the 200 ankles, 119 patients had inflammatory arthritis and 81 patients 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 five-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 old 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 six 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).

The remaining information in this Rationale summarizes several prior key studies that detail concerns with earlier attempts at total ankle replacement.

One case series of 100 consecutive total ankle replacements using the Agility™ Total Ankle System (DePuy, Inc., Warsaw, IN) has been published (Pyevich, 1998). Follow-up ranged from 2 to 12 years; the prostheses were implanted between 1984 and 1993. Individuals were evaluated with an interview focusing on pain and activities of daily living, and clinical and radiologic examination. Of the 85 ankles in 83 patients that were available for follow-up, 98% were associated with some level of pain relief. A total of 74% of patients reported an increase in their functional level. Based on radiologic exam, 36% of prostheses were associated with a delayed union or nonunion. Migration of talar or tibial components of the prosthesis were also noted; migration of the tibial component was associated with nonunion. Nonunion was associated with ballooning lysis at the interface between the bone and tibial component, although lysis was also seen in cases when a solid union was present. The authors conclude that these intermediate results are encouraging, although the radiographic findings created concerns about long-term outcomes. Another case series of 86 cases has been published and reported similar results (Conti, 1999). While 79 of the 86 cases (92%) reported a favorable outcome, there were similar radiographic findings. A total of 22% of prosthetic components had migrated, and 8 of the 12 tibial components that had migrated involved a delayed union or nonunion. The lack of any control group precludes a comparison of the prosthesis with arthrodesis. Since the Agility Total Ankle System received U.S. Food and Drug Administration (FDA) clearance for marketing through the 510(k) process, detailed clinical outcomes were not required for FDA approval. While several authors suggest that this prosthesis is most commonly used in this country, no additional clinical studies of the Agility Total Ankle System were identified in a literature search.

Additional reviews have detailed the numerous technical challenges of total ankle replacement, including the evolving prosthetic designs, optimizing postoperative biomechanics and surgical complications. In general, second generation devices have shown positive intermediate outcomes but published results are limited and anecdotal. Buechel and colleagues (2003) reported on a case series of 50 ankle replacements in 49 patients using the Buechel Pappas device. Patients were followed up for 2 to 10 years. This article focused primarily on the surgical technique and did not report member outcomes in detail. For example, while outcome was reported as excellent or good in 48% and 40% of patients, respectively, there was inadequate detail documenting how this outcome was assessed. In addition, the Buechel Pappas device is not commercially available currently.

There remains a high complication rate with all prostheses and a frequent need for re-operation (Kopp, 2006; San Giovanni, 2006). Schuberth (2006) reported that total ankle replacement is associated with a learning curve and the surgeon experience can influence the clinical outcome. Doets (2006) states total ankle replacement should be restricted to the experienced ankle surgeon. Kopp (2006) and Schuberth (2006) reported concerning radiographic findings of perioprosthetic lucency that could perhaps compromise the longevity of the prosthesis. They concluded that additional studies are necessary.

In a systematic review of the literature addressing the intermediate and long-term outcomes of total ankle replacement and ankle arthrodesis Haddad (2007) states that the evidence suggests that these two procedures have equivalent outcomes in terms of ankle function, pain, revision, conversion to arthrodesis, implant survival and quality of life. They did not perform a comparison of safety and efficacy. The authors noted that their study exposed a lack of objective, prospective and controlled data on either procedure and the available data are predominantly from retrospective, uncontrolled case series from single institutions.

|Background/Overview |

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:

• Resolution of pain

• Function of both the ankle and proximal joint in various activities, such as walking on flat or irregular surfaces, or walking up stairs

• Long-term outcomes

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.

|Definitions |

Arthrodesis: the surgical fusion of a joint

Arthroplasty: a procedure in which a joint is removed and replaced with a prosthesis

|Coding |

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:

|CPT |  |

|27702 |Arthroplasty, ankle; with implant (total ankle) |

|27703 |Arthroplasty, ankle; revision, total ankle |

|  |  |

|ICD-9 Procedure |  |

|81.56 |Total ankle replacement |

|  |  |

|ICD-9 Diagnosis |  |

|714.0-714.9 |Rheumatoid arthritis and other inflammatory polyarthropathies |

|715.17 |Osteoarthrosis, localized, primary, ankle and foot |

|715.27 |Osteoarthrosis, localized, secondary, ankle and foot |

|715.37 |Osteoarthrosis, localized, not specified whether primary or secondary, ankle and foot |

|715.97 |Osteoarthrosis, unspecified whether generalized or localized, ankle and foot |

|716.17 |Traumatic arthropathy, ankle and foot |

|716.57 |Unspecified polyarthropathy or polyarthritis, ankle and foot |

|716.67 |Unspecified monoarthritis, ankle and foot |

|716.87 |Other specified arthropathy, ankle and foot |

|716.97 |Arthropathy, unspecified, ankle and foot |

|719.47 |Pain in joint, ankle and foot |

|996.40-996.49 |Mechanical complication of internal orthopedic device, implant, and graft |

|V43.66 |Organ or tissue replaced by other means, 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.

|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. Bonnin M, Judet T, Colombier JA, et al. Midterm results of the Salto Total Ankle Prosthesis. Clin Orthop Relat Res. 2004; (424):6-18.

3. Buechel FF Sr, Buechel FF Jr, Pappas MJ. Ten-year evaluation of cementless Buechel-Pappas meniscal bearing total ankle replacement. Foot Ankle Int. 2003; 24(6):462-472.

4. Colman AB, Pomeroy GC. Transfibular ankle arthrodesis with rigid internal fixation: an assessment of outcome. Foot Ankle Int. 2007; 28(3):303-307.

5. Conti SF, Bisignani G, Martin R. Update on total ankle replacement. Semin Arthroplasty Reconstruct Foot Ankle. 1999; 10:62-71.

6. Conti SF, Wong YS. Complications of total ankle replacement. Foot Ankle Clin. 2002; 7(4):791-807.

7. Doets H, Brand R, Nelissen R. Total ankle arthroplasty in inflammatory joint disease with use of two mobile-bearing designs. J Bone Joint Surg Am. 2006; 88(6):1272-1284.

8. Dyrby C, Chou LB, Andriacchi TP, Mann RA. Functional evaluation of the Scandinavian total ankle replacement. Foot ankle Int. 2004; 25(6):377-381.

9. Easley ME, Vertullo CJ, Urban WC, Nunley JA. Total ankle arthroplasty. J Am Acad Orthop Surg. 2002; 10(3):157-167.

10. Gill LH. Challenges in total ankle arthroplasty. Foot Ankle Int. 2004; 25(4):195-207.

11. Guyer AJ, Richardson G. Current concepts review: total ankle arthroplasty. Foot Ankle Int. 2008; 29(2):256-264.

12. Haddad SL, Coetzee JC, Estok R, et al. Intermediate and long-term outcomes of total ankle arthroplasty and ankle arthrodesis. A systematic review of the literature. J Bone Joint Surg Am. 2007; 89(9):1899-1905.

13. Hintermann B, Valderrabano V. Total ankle replacement. Foot Ankle Clin 2003; 8(2):375-405.

14. Hopgood P, Kumar R, Wood PL. Ankle arthrodesis for failed total ankle replacement. 2006; 88(8):1032-1038.

15. Hurowitz EJ, Gould JS, Fleisig GS, Fowler R. Outcome analysis of agility total ankle replacement with prior adjunctive procedures: two to six year followup. Foot Ankle Int. 2007; 28(3):308-312.

16. Knecht SI, Estin M Callaghan JJ, et al. The Agility total ankle arthroplasty. Seven to sixteen-year follow-up. J Bone Joint Surg Am. 2004; 86-A(6):1161-1171.

17. Kopp FJ, Patel MM, Deland JT, O'Malley MJ. Total ankle arthroplasty with the Agility prosthesis: clinical and radiographic evaluation. Foot Ankle Int. 2006; 27(2):97-103.

18. Kotnis R, Pasapula C, Anwar F, et al. The management of failed ankle replacement. J Bone Joint Surg Br. 2006; 88(8):1039-1047.

19. Morse KR, Flemister AS, Baumhauer JF, DiGiovanni BF. Distraction arthroplasty. Foot Ankle Clin. 2007; 12(1):29-39.

20. Pyevich MT, Saltzman CL, Callaghan JJ, Alvine FG. Total ankle arthroplasty: a unique design. Two to twelve-year follow-up. J Bone Joint Surg Am. 1998; 80(10):1410-1420. 

21. Raikin SM, Myerson MS. Avoiding and managing complications of the Agility Total Ankle Replacement system. Orthopedics. 2006; 29(10):930-938.

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. San Giovanni TP, Keblish DJ, Thomas WH, Wilson MG. Eight-year results of a minimally constrained total ankle arthroplasty. Foot Ankle Int. 2006; 27(6):418-426.

24. Schuberth JM, Patel S, Zarutsky E. Perioperative complications of the Agility total ankle replacement in 50 initial, consecutive cases. J Foot Ankle Surg. 2006; 45(3):139-146.

25. 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.

26. 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.

27. 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.

28. Stamatis ED, Myerson MS. How to avoid specific complications of total ankle replacement. Foot Ankle Clin. 2002; 7(4):765-789.

29. 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

30. 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.

31. Wood PL, Deakin S. Total ankle replacement. The results in 200 ankles. J Bone Joint Surg Br. 2003; 85(3):334-341.

32. 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.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Orthopaedic Foot & Ankle Society. Position statement on Total Ankle Replacement Surgery (2009). Available at: . Accessed on February 26, 2010.

|Index |

Agility™ Total Ankle System

Ankle Arthroplasty

Ankle Replacement

Buechel-Pappas Total Ankle Replacement System

Eclipse Total Ankle Implant

INBONE™ Total Ankle System

SALTO Talaris Total Ankle Prosthesis

STAR Prosthesis

Topez Total Ankle Replacement System

Total Ankle Replacement

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.

|Document History |

|Status |Date |Action |

|Revised |05/13/2010 |Medical Policy & Technology Assessment Committee (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 Websites. |

|  |06/03/2009 |Updated Rationale to include FDA approval of total knee 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 |

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