METHOD: Peer reviewed English language publications of human, Therapeutic Studies only – investigating the efficacy of total ankle arthroplasty were evaluated. Repetitive evaluation and similar results of same date sets were not included.

Preponderance of studies are unfavorable with an overall Level III rating (>25% are Level III or better) for predicting success – or neutral with an overall Level III rating (>25% are Level III or better) for predicting success. Favorable studies are in the minority with an overall Level IV rating (>25% Level IV of better.) The preponderance of data for unfavorable or neutral is of a greater strength and number than favorable.p>

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TOTAL ANKLE ARTHRO-PLASTY

Studies Favorable:  Total 22

Level II:  1 Study

1. Total Ankle Arthroplasty in Inflammatory Joint Disease with Use of Two Mobile-Bearing Designs .
H. Cornelis Doets, Ronald Brand, and Rob G.H.H. Nelissen.
J. Bone Joint Surg. Am., Jun 2006; 88: 1272 – 1284.
A prospective observational study on patients with the diagnosis of inflammatory joint disease or has provided a detailed analysis of the risk factors for failure. Ninety-three total ankle arthroplasties were performed. The clinical result at one year after surgery showed a significant improvement in the scores on all three scoring systems. Mobile-bearing total ankle arthroplasty is a valid treatment option for the rheumatoid ankle if proper indications are used. Aseptic loosening and persistent deformity are the most important modes of failure.
Level II – Favorable

Level IV:  21 Studies

1. Intermediate and Long-Term Outcomes of Total Ankle Arthroplasty and Ankle Arthrodesis. A Systematic Review of the Literature.
S.L. Haddad, J.C. Coetzee, R. Estok, K. Fahrbach, D. Banel, and L. Nalysnyk.
J. Bone Joint Surg. Am., Sep 2007; 89: 1899 – 1905.
Literature review 5 star randomized controlled trials, 4 star prospective and retrospective non-randomized controlled trials, and 2 star case series studies. the intermediate and long-term outcomes analyzed in this review do suggest that total ankle arthroplasty is comparable with ankle arthrodesis, but data is limited.
Level IV – Favorable

2.   Total Ankle Arthroplasty: a Unique Design. Two to Twelve-Year Follow-up.
Michael T. Pyevitch, Charles L. Saltzman, John J. Callaghan, and Frank G. Alvine.
J. Bone Joint Surg. Am., Oct 1998; 80: 1410 – 20.
Case series study including one hundred consecutive Agility ankle replacements were performed in ninety-five patients between 1984 and 1993. The early experience with the Agility ankle implant is encouraging; the results appear to be better than those associated with most other ankle prostheses. In the present series, most patients were satisfied with the outcome of the operation and were functioning well with the implant.
Level IV – Favorable

3.  The Agility Total Ankle Arthroplasty. Seven to Sixteen-Year Follow-up.
Stephen I. Knecht, Miriam Estin, John J. Callaghan, Miriam B. Zimmerman, Kyle J. Alliman, Frank G. Alvine, and Charles L. Saltzman.
J. Bone Joint Surg. Am., Jun 2004; 86: 1161 – 1171.
Case series study. We conducted an independent review of all Agility total ankle replacements performed by a single surgeon between 1984 and 1994. Included one hundred and thirty-two arthroplasties were performed in 126 patients. The relatively low rates of radiographic hindfoot arthritis and revision procedures at an average of nine years after the arthroplasty are encouraging. Agility total ankle replacement is a viable and durable option for the treatment of ankle arthritis in selected patients.
Level IV – Favorable

4.  Total ankle replacement in rheumatoid arthritis .
PF Lachiewicz, AE Inglis, and CS Ranawat.
J. Bone Joint Surg. Am., Mar 1984; 66: 340 – 343.
Case series study. Included rheumatoid arthritis patients. Fifteen single-axis arthroplasties, fourteen of the Mayo and one of the Buchholz type, after an average follow-up of thirty-nine months seven ankles were rated excellent and eight, good. The relief of pain was gratifying in all of the patients, only four patients having residual slight pain with starting activity. The average gain in the range of motion was 9 degrees. No patient had loosening that required reoperation, although radiolucent lines were seen in eleven ankles. Likely to be successful in carefully selected rheumatoid arthritis patients.
Level IV – Favorable

5.  Outcome analysis of agility total ankle replacement with prior adjunctive procedures: two to six year followup.
Hurowitz EJ, Gould JS, Fleisig GS, Fowler R.
Foot Ankle Int. 2007 Mar;28(3):308-12.
A retrospective case review (series) of 65 agility total ankle replacements (64 patients) was done between April, 1998, and March, 2002. Patients with rheumatoid arthritis (RA) were found to have a statistically significant lower rate of failure.
Level IV – Favorable

6.  Functional evaluation of the Scandinavian Total Ankle Replacement .
Dyrby C, Chou LB, Andriacchi TP, Mann RA.
Foot Ankle Int. 2004 Jun;25(6):377-81.
Series, no control group. Scandinavian Total Ankle Replacement (STAR). Nine patients (six males and three females) with an average age of 65 years, scheduled for unilateral total ankle replacement for osteoarthritis and rheumatoid arthritis, were evaluated both preoperatively and postoperatively in a gait analysis laboratory. Arthroplasty patients showed reduced range of motion at the ankle compared to normal controls. Postoperative arthroplasty subjects had significantly improved external ankle dorsiflexion moment, the moment that affects the plantarflexor muscles, when compared to their preoperative status. The moment in arthroplasty patients was increased, indicating improved function of the ankle joint.
Level IV – Favorable

7.  An artificial ankle joint.
Newton SE.
Clin Orthop Relat Res. 1979 Jul-Aug;(142):141-5.
Case series, no control. Study of 50 total ankle arthroplasty cases shows that predictably good results can be obtained in ankles with good stability, reasonably normal anatomy, and rheumatoids who are not on long-term steroid therapy.
Level IV – Favorable

8.  Total ankle arthroplasty in rheumatoid arthritis: a long-term follow-up study.
Unger AS, Inglis AE, Mow CS, Figgie HE 3rd.
Foot Ankle. 1988 Feb;8(4):173-9.Links
Case series. Patients with rheumatoid arthritis who had undergone total ankle arthroplasty and had a minimum of 2 yr follow-up were studied. Of the original 21 patients 17 were available for review. Twenty-three ankle replacements with an average follow-up of 5.6 yr were studied. On follow-up 2 ankles were rated excellent, 13 were rated good, 4 were rated fair, and 4 were rated poor. Thus, 83% were satisfactory on follow-up. Radiographic analysis revealed migration and settling of the talar component in 14 of 15 cases. Bone cement radiolucencies were found in 14 of 15 cases. Bone cement radiolucencies were found in 14 of 15 tibial components with tilting in 12 of these components. The postoperative position of the implant did not correlate with the development of radiolucencies or migration of the implant.
Level IV – Favorable

9.  A comparative study of cemented metal and uncemented ceramic prostheses.
Takakura Y, Tanaka Y, Sugimoto K, Tamai S, Masuhara K. Ankle arthroplasty
Clin Orthop Relat Res. 1990 Mar;(252):209-16.
Case series. From 1975 to 1980, total ankle arthroplasty was performed using a metal and polyethylene prosthesis on 30 ankles in 28 patients with painful arthritis. However, because loosening and sinking of the prosthesis were significant, a ceramic total prosthesis was designed in 1980 to be used without cement. Between 1980 and 1987, 39 ankles in 35 patients with osteoarthritis, rheumatoid arthritis, and hemophilic arthritis were replaced using the ceramic prosthesis. Out of 39 ankles, nine were replaced with cement and 30 without cement. The follow-up period for the cemented metal and ceramic cases ranged from 13.4 to 6.2 years, with an average of 8.1 years, and for uncemented ceramic cases from 1.2 to 6.4 years, with an average of 4.1 years. Based on a rating scale for ankle evaluation, 27% of the cemented cases and 67% of the uncemented cases are satisfactory. Five metal ankles and one ceramic ankle were reoperated upon, with one revision and five arthrodeses performed. Ceramic total ankle arthroplasty, performed without cement, has to date provided mostly excellent stable results.
Level IV – Favorable

10.  Ten-year evaluation of cementless Buechel-Pappas meniscal bearing total ankle replacement.
Buechel FF Sr, Buechel FF Jr, Pappas MJ.
Foot Ankle Int. 2003 Jun;24(6):462-72.Links
Case series. Fifty deep-sulcus (Buechel-Pappas) total ankle replacements were implanted in 49 patients. Clinical results using a strict ankle scoring system demonstrated good/excellent results in 88% of cases.
Level IV – Favorable

11.  Total ankle replacement.
Lodhi Y, McKenna J, Herron M, Stephens MM.
Ir Med J. 2004 Apr;97(4):104-5.Links
Case series. 29 patients underwent 30 Scandinavian Total Ankle Replacements (STAR) by a single surgeon, over a four year period (1997 to 2001). Our intermediate term result for the STAR (W. Link GmbH & Co., Hamburg, Germany) ankle replacement has yielded 90% excellent and good functional outcomes in a mixed osteo arthritic and rheumatoid population which mirrors the results of those published from Scandinavia.
Level IV – Favorable

12.  Total ankle replacement in patients with rheumatoid arthritis.
Su EP, Kahn B, Figgie MP.
Clin Orthop Relat Res. 2004 Jul;(424):32-8.Click here to read Links
Case series. To date, with 6.4 years followup, the ankles are clinically doing well, as evidenced by high AOFAS ankle-hindfoot scores. Radiographs have shown implant stability in 88.5% of ankles.
Level IV – Favorable

13.  Efficacy of total ankle replacement with meniscal-bearing devices: a systematic review and meta-analysis.
Stengel D, Bauwens K, Ekkernkamp A, Cramer J.
Arch Orthop Trauma Surg. 2005 Mar;125(2):109-19. Epub 2005 Feb 3.
Systematic review. Meta-analysis of studies exploring the efficacy of three-component total ankle prostheses. We demanded a minimum sample size of 20 subjects, at least 1 year of follow-up, and a clinically relevant study endpoint (for example, results of ankle scoring, ranges of motion [ROM], complications, and survival rates). Ankle arthroplasty improves pain and joint mobility in end-stage ankle arthritis.
Level IV – Favorable

14.  Total ankle replacement. Early experiences with STAR prosthesis.
Murnaghan JM, Warnock DS, Henderson SA.
Ulster Med J. 2005 May;74(1):9-13.
Case series reporting a review of the early results of our first 22 prostheses in 20 patients undergoing Scandinavian Total Ankle Replacement (STAR) in Northern Ireland. These early results show high levels of patient satisfaction, and we are encouraged to continue with total ankle arthroplasty.
Level IV – Favorable

Level III:  1 Study

1.  Comparison of Reoperation Rates Following Ankle Arthrodesis and Total Ankle Arthroplasty.
Nelson F. SooHoo, David S. Zingmond, and Clifford Y. Ko.
J. Bone Joint Surg. Am., Oct 2007; 89: 2143 – 2149.
Retrospective, comparative non-randomized uncontrolled study. A total of 4705 ankle fusions and 480 ankle replacements were performed during the ten-year study period. This study confirms that, compared with ankle fusion, ankle replacement is associated with a higher risk of complications but also potential advantages in terms of a decreased risk of the patient requiring subtalar joint fusion. Additional controlled trials are needed to clarify the appropriate indications for ankle arthrodesis and ankle replacement.
Level III – Unfavorable

Level IV:  6 Studies

1.  Uncemented STAR total ankle prostheses. Three to eight-year follow-up of fifty-one consecutive ankles.
Anderson T, Montgomery F, Carlsson A.
J Bone Joint Surg Am. 2003 Jul;85-A(7):1321-9.
Case series. Intermediate-term results of fifty-one consecutive Scandinavian Total Ankle Replacements (STAR). Between 1993 and 1999, fifty-one consecutive ankles were replaced with an uncemented, hydroxyapatite-coated STAR total ankle prosthesis.
Total ankle replacement may be a realistic alternative to arthrodesis, provided that the components are correctly positioned and are of the correct size. However, the risks of loosening and failure are still higher than are such risks after total hip or total knee replacement.
Level IV – Unfavorable >

2.  Clinical Results of the Mayo Total Ankle Arthroplasty.
Harold B. Kitakoka and Gary L. Patzer.
J. Bone Joint Surg. Am., Nov 1996; 78: 1658 – 64.
Case series study. Two hundred and four primary Mayo total ankle arthroplasties were performed in 179 patients at the Mayo Clinic from 1974 through 1988. The relatively high rates of complications and reoperations are of concern. For these reasons, we no longer recommend ankle arthroplasty with the constrained Mayo implant for rheumatoid arthritis or osteoarthrosis of the ankle.
Level IV – Unfavorable

3.  Total ankle arthroplasty. Clinical study of fifty cases.
SE Newton.
J. Bone Joint Surg. Am., Jan 1982; 64: 104 – 111.
Case series study. A prosthesis for the ankle joint designed in 1973 was implanted in fifty patients who otherwise would have required fusion of the ankle to relieve severe pain. Ankle fusion remains the procedure of choice for most painful ankle conditions, particularly if the subtalar and mid-tarsal joints are not involved and if the patient subjects the extremity to high levels of activity.
Level IV – Unfavorable

4.  Total ankle arthroplasty with the Agility prosthesis: clinical and radiographic evaluation.
Kopp FJ, Patel MM, Deland JT, O’Malley MJ.
Foot Ankle Int. 2006 Feb;27(2):97-103.
Retrospective case series study reviewing the results of total ankle arthroplasty in 41 consecutive patients (43 ankles). Agility total ankle arthroplasty results in a favorable clinical outcome and patient satisfaction in most patients at intermediate-term followup. However, total ankle arthroplasty is associated with potential complications and the need for subsequent operative intervention. Radiographic followup commonly reveals periprosthetic lucency, lysis, and component migration or subsidence, but this does not appear to adversely affect the intermediate-term clinical outcome. The long-term consequences of such radiographic findings are of concern, and surgeons and patients choosing this procedure need to be cautious.
Level IV – Unfavorable >

5.  Total ankle arthroplasty. A long-term review of the London Hospital experience.
Bolton-Maggs BG, Sudlow RA, Freeman MA.
J Bone Joint Surg Br. 1985 Nov;67(5):785-90.
Case series. Retrospective study of 62 total ankle arthroplasties performed between 1972 and 1981. Only 13 can be described as satisfactory. The complications encountered in all 62 arthroplasties are detailed, the most significant being superficial wound healing problems, talar collapse, and loosening of the components; 13 prosthetic joints have already been removed and arthrodesis attempted. High complication rate and the generally poor long-term clinical results, we recommend arthrodesis as the treatment of choice.
Level IV – Unfavorable

6.   Survivorship analysis of the Mayo total ankle arthroplasty.
HB Kitaoka, GL Patzer, DM Ilstrup, and SL Wallrichs.
J. Bone Joint Surg. Am., Jul 1994; 76: 974 – 979.
Case series study. From 1974 until the end of 1988, 204 primary Mayo total ankle arthroplasties were performed at the Mayo Clinic. We do not recommend the use of the Mayo total ankle arthroplasty, particularly in younger patients who have had a previous operative procedure on the ipsilateral ankle or foot.
Level IV – Unfavorable

TOTAL ANKLE ARTHRO-PLASTY
Studies Neutral:  Total 5

Level II:  1 Study

1.  Total ankle replacement in ankle osteoarthritis: an analysis of muscle rehabilitation.
Valderrabano V, Nigg BM, von Tscharner V, Frank CB, Hintermann B. J. Leonard Goldner Award 2006.
Foot Ankle Int. 2007 Feb;28(2):281-91.
Prospective cohort study on total ankle replacement for unilateral severe ankle osteoarthritis. Fifteen patients were assessed before and after TAR in 3-month intervals up to 1 year. TAR surgery improved muscle function (torque, EMG intensity) in osteoarthritic ankles. However, after 1 year, patients did not reach the level of the contralateral healthy leg, and the EMG frequency remained unchanged.
Level II – Neutral

Level III:  1 Study

1. Comparative analysis of ankle arthroplasty versus ankle arthrodesis.
McGuire MR, Kyle RF, Gustilo RB, Premer RF.
Clin Orthop Relat Res. 1988 Jan;(226):174-81.
Retrospective cohort study of 41 patients with total ankle arthroplasty (25 patients) and ankle arthrodesis (18 patients), the mean follow-up period was 3.8 years for total ankle arthroplasties and 3.3 for ankle arthrodeses. Sixteen of the 23 ankle arthroplasty patients, and 17 of the 18 arthrodesis patients had good or excellent results.
Level III – Neutral

Level IV: 3 Studies

1. Total ankle replacement. The results in 200 ankles.
Wood PL, Deakin S.
J Bone Joint Surg Br. 2003 Apr;85(3):334-41.
Case series. Between 1993 and 2000 we implanted 200 cementless, mobile-bearing STAR total ankle replacements. These results of ankle replacement are encouraging but
The follow-up is only midterm. It seems probable that ankle replacement will find a place alongside other joint replacements but it is unlikely that it will displace fusion as has occurred in the knee.
Level IV – Neutral

2. Complications and Failure After Total Ankle Arthroplasty.
Adrienne A. Spirt, Mathieu Assal, and Sigvard T. Hansen, Jr.
J. Bone Joint Surg. Am., Jun 2004; 86: 1172 – 1178.
Retrospective, case series study on the cause and frequency of reoperation and failure after total ankle arthroplasty. Three hundred and six consecutive primary total ankle arthroplasties were performed with use of the DePuy Agility Total Ankle System between 1995 and 2001. Relatively high rate of reoperation after total ankle arthroplasty with this second-generation device. Younger age was found to have a negative effect on the rates of reoperation and failure. Most prostheses could be salvaged; however, the functional outcome of this procedure is uncertain.
Level IV – Neutral

3.  Total joint arthroplasty. The ankle.
Stauffer RN.
Mayo Clin Proc. 1979 Sep;54(9):570-5.
Case series, no control. The Mayo total ankle replacement is a metal-on-polyethylene, congruent, constrained prosthesis. Analysis of 94 patients (102 ankle prostheses) revealed good clinical results in patients with rheumatoid arthritis and in older persons with posttraumatic degenerative disease. Younger, more active patients in the latter category had more disappointing results. Further design development is under way to improve range-of-motion characteristics, decrease constraint forces, and improve bone fixation of the prosthetic components.
Level IV – Neutral

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