K0038 Total Ankle Replacements final by gdf57j

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									TITLE: Total Ankle Replacements: Clinical Effectiveness and a Review of the Guidelines


DATE: 20 October 2008


RESEARCH QUESTIONS:

1.        What is the clinical effectiveness of total ankle replacements?

2.        What are the guidelines regarding total ankle replacements?

METHODS:

A limited literature search was conducted on key health technology assessment resources,
including PubMed, the Cochrane Library (Issue 4, 2008), University of York Centre for Reviews
and Dissemination (CRD) databases, ECRI, EuroScan, international health technology
agencies, and a focused Internet search. Results include articles published between 2003 and
October 2008, and are limited to English language publications only. No filters were applied to
limit the retrieval. Internet links are provided, where available.

The summary of findings was prepared from the abstracts of the relevant information. Please
note that data contained in abstracts may not always be an accurate reflection of the data
contained within the full article.

RESULTS:

The literature search identified two systematic reviews, three controlled clinical trials, and thirty-
four observational studies. Of the observational studies, two have been included in the main
report. The remainder, which did not directly compare ankle replacement with ankle arthrodesis
or were not specific to the Hintegra® prosthesis, are listed in the appendix with other articles of
potential interest. The literature search did not identify any health technology assessments,
randomized controlled trials, or evidence-based guidelines.


Disclaimer: The Health Technology Inquiry Service (HTIS) is an information service for those involved in planning and providing
health care in Canada. HTIS responses are based on a limited literature search and are not comprehensive, systematic reviews.
The intent is to provide a list of sources of the best evidence on the topic that CADTH could identify using all reasonable efforts
within the time allowed. HTIS responses should be considered along with other types of information and health care considerations.
The information included in this response is not intended to replace professional medical advice, nor should it be construed as a
recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality
evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for
which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation
of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect.
CADTH is not liable for any loss or damages resulting from use of the information in the report.

Copyright: This report contains CADTH copyright material and may contain material in which a third party owns copyright. This
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Links: This report may contain links to other information on available on the websites of third parties on the Internet. CADTH does
not have control over the content of such sites. Use of third party sites is governed by the owners’ own terms and conditions.
HTIS reports are organized so that the higher quality evidence is presented first. Therefore,
health technology assessment reports, systematic reviews, and meta-analyses are presented
first. These are followed by randomized controlled trials, controlled clinical trials, observational
studies, and evidence-based guidelines.


OVERALL SUMMARY OF FINDINGS:

Two systematic reviews were identified. Haddad et al. (2007)1 performed a systematic review
comparing total ankle arthroplasty with ankle arthrodesis. The review included 49 studies; 10
studies of ankle arthroplasty and 39 studies of ankle arthrodesis. The comparative results are
shown in Table 1.
                                                                                          1
Table 1: Comparison of ankle arthroplasty and ankle arthrodesis outcomes, Haddad et al.
             Outcomes                   Ankle arthroplasty (n=852 patients)   Ankle arthrodesis (n=1,262 patients)
AOFAS Ankle-Hindfoot Scale score       78.2 points (95%CI, 71.9-84.5)         75.6 points (95%CI, 71.6-79.6)
Rating of results (% of patients)      Excellent: 38%                         Excellent: 31%
                                       Good: 30.5%                            Good: 37%
                                       Fair: 5.5%                             Fair: 13%
                                       Poor: 24%                              Poor: 13%
Revision rate                          7% (95%CI, 3.5-10.9)                   9% (95%CI, 5.5-11.6)
Percentage of patients requiring       1%                                     5%
below-the-knee amputation
AOFAS=American Orthopaedic Foot and Ankle Society; CI=confidence interval

The five-year implant survival rate was 78% (95%CI, 69.0-87.6), and the 10-year survival rate
was 77% (95%CI, 63.3-90.8). The authors noted that data were sparse and more comparative
studies were needed to strengthen the conclusion. However, they stated that the intermediate
outcomes of total ankle arthroplasty and ankle arthrodesis appeared to be similar.

Stengel et al. (2005)2 conducted a systematic review/meta-analysis to investigate the efficacy of
three-component ankle implants in patients with end-stage arthritis. The review included 18
studies (n=1,086 patients) of five implants: Scandinavian Total Ankle Replacement (STAR),
Buechel-Pappas, LCS, RAMSES, and ESKA implants. The pooled outcomes reported in the
review were:
    • standardized 100-point ankle and hindfoot scores pooled from 10 trials (n=497) showed
        a mean improvement of 45.2 points (95%CI, 39.3-51.1)
    • overall range of motion improved slightly; 6.3 degrees (95%CI, 2.2-10.5)
    • weighted complication rates ranged from 1.6% (deep infections) to 14.7% (impingement)
    • secondary surgery was required in 12.5% of cases and secondary arthrodesis was
        required in 6.3% of cases
    • weighted five-year prosthesis survival rate averaged 90.6%
The authors concluded that ankle arthroplasty improved pain and joint mobility in end-stage
ankle arthritis. However, due to the poor quality of the included studies, further comparison of
ankle fusion with total ankle replacement should be conducted with a well-designed,
randomized trial.

Three controlled clinical trials, all addressing gait, were identified. Houdijk et al. (2008)3
compared mechanical load and quasi-stiffness of the ankle joint in 10 total ankle replacement
(TAR) patients and 10 age-matched healthy control subjects, walking barefoot on an indoor
track, at self-selected walking speeds. No differences were observed between the two groups in
peak moments or in the stiffness coefficient. Internal work at the ankle during the step was


    Total Ankle Replacements                                                                                   2
considered to be significantly different (p=0.02) for TAR [-0.078 (0.088) J kg(-1)] versus control
[0.005 (0.048) J kg(-1)], but it was thought this might be due to minor differences in walking
speeds between the two groups. The authors concluded that, although there was a small
difference in internal work at the ankle, the difference in mechanical loading of the ankle after
TAR was not significantly different compared with normal subjects.

Piriou et al. (2008)4 compared before and after gait analyses of 12 patients who received ankle
arthroplasty to 12 patients who received ankle arthrodesis, and to a control group of 12 healthy
subjects. Time of analysis post-surgery, and a comparison of pre- and post-intervention
outcomes were not reported in the abstract. No data from comparisons of either intervention to
the control group was reported in the abstract. Patients with ankle arthrodesis demonstrated a
faster gait and longer step length compared with ankle replacement. Ankle replacement patients
showed restored ground reaction force pattern, greater symmetry in gait, and greater movement
at the ankle than the arthrodesis group. The authors concluded that ankle replacement resulted
in a significantly slower gait, but the improved symmetry (timing) resulted in limp reduction.

Doets et al. (2007)5 compared gait analysis of 10 patients who received uneventful total ankle
replacements (time of analysis post-surgery not reported) with 10 healthy control subjects,
during barefoot walking. Compared with the control group, the ankle replacement group
showed:
    • 6% lower velocity
    • reduced dorsiflexion (p<0.001)
    • no differences in the joint angular pattern of the knee joint
    • minimal changes at the hindfoot-to-tibia and forefoot-to-hindfoot levels
    • increased ground reaction force at midstance (p=0.005)
    • decreased magnitude of the vertical peak at terminal stance (p<0.001)
    • electromyographic (EMG) activity patterns not fully normalized
The authors concluded that, although ground reaction forces and EMG activity did not fully
normalize, the remainder of the gait pattern was near normal, following uneventful total ankle
replacement.

One comparative observational study and one observational study specific to the Hintegra®
device were identified by the literature search. SooHoo et al. (2007)6 retrospectively compared
re-operation rates following 480 ankle replacements and 4,705 ankle fusions, over a 10-year
period. Outcomes reported were:
    •   rates of major revision surgery were significantly higher (p<0.001) for ankle replacement
        than ankle arthrodesis; 9% for ankle replacement and 5% for ankle arthrodesis at one
        year; 23% for ankle replacement and 11% for ankle arthrodesis at five years
    •   rates of subtalar fusion were lower with ankle replacement (p=0.03); 0.7% for ankle
        replacement and 2.8% for ankle arthrodesis
The authors concluded that ankle replacement was associated with a higher rate of
complications than ankle arthrodesis, but showed a decreased risk of the patient requiring
subtalar joint fusion.

Hintermann et al. (2004)7 describe a study of short-term outcomes in 116 patients (122 ankles)
receiving the Hintegra® ankle prosthesis. The average length of follow-up was 18.9 months
(range 1-3 years). Eight ankles required revision. The clinical result was rated as excellent or
good in 82% of the cases, and 84% of patients were satisfied. AOFAS hindfoot score improved
from 40 points pre-operatively to 85 points post-operatively. Eighty-three ankles (68%) were
pain-free. The tibial component was stable in all ankles, and with no tilting since surgery. Two



   Total Ankle Replacements                                                                   3
ankles showed migration of the talar component. The authors concluded that the outcomes of
function, pain relief, and patient satisfaction were promising and mostly superior to those
outcomes with other devices.

In summary, outcomes for total ankle replacement were comparable to and, in some cases,
superior to those for ankle arthrodesis. However, most authors stated that good quality,
comparative trials are necessary to confirm their conclusions. The single observational study on
the Hintegra® ankle (2004)7 concluded that this device may be successful as a total ankle
replacement.




   Total Ankle Replacements                                                                 4
REFERENCES SUMMARIZED:

Health technology assessments
No literature identified

Systematic reviews and meta-analyses

1.       Haddad SL, Coetzee JC, Estok R, Fahrbach K, Banel D, Nalysnyk L. 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):1899-905. PubMed:
         PM17768184

2.       Stengel D, Bauwens K, Ekkernkamp A, Cramer J. Efficacy of total ankle replacement
         with meniscal-bearing devices: a systematic review and meta-analysis. Arch Orthop
         Trauma Surg 2005;125(2):109-19. PubMed: PM15690167
         Structured abstract available:
         http://www.mrw.interscience.wiley.com/cochrane/cldare/articles/DARE-
         20059848/frame.html (accessed 2008 Oct 9).

Randomized controlled trials
No literature identified

Controlled clinical trials

3.       Houdijk H, Doets HC, van Middelkoop M, Dirkjan Veeger HE. Joint stiffness of the ankle
         during walking after successful mobile-bearing total ankle replacement. Gait Posture
         2008;27(1):115-9. PubMed: PM17462899

4.       Piriou P, Culpan P, Mullins M, Cardon JN, Pozzi D, Judet T. Ankle replacement versus
         arthrodesis: a comparative gait analysis study. Foot Ankle Int 2008;29(1):3-9. PubMed:
         PM18275730

5.       Doets HC, van Middelkoop M, Houdijk H, Nelissen RG, Veeger HE. Gait analysis after
         successful mobile bearing total ankle replacement. Foot Ankle Int 2007;28(3):313-22.
         PubMed: PM17371655


Observational studies

6.       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):2143-9.
         PubMed: PM17908889

7.       Hintermann B, Valderrabano V, Dereymaeker G, Dick W. The HINTEGRA ankle:
         rationale and short-term results of 122 consecutive ankles. Clin Orthop Relat Res
         2004;(424):57-68. PubMed: PM15241144

Guidelines and recommendations
No literature identified




     Total Ankle Replacements                                                                 5
PREPARED BY:
Karen Cimon, Research Assistant
Jessie Cunningham, MISt, Information Specialist
Health Technology Inquiry Service
Email: htis@cadth.ca
Tel: 1-866-898-8439




   Total Ankle Replacements                       6
APPENDIX – FURTHER INFORMATION:

Economic analyses and cost information

8.        SooHoo NF, Kominski G. Cost-effectiveness analysis of total ankle arthroplasty. J Bone
          Joint Surg Am 2004;86-A(11):2446-55. PubMed: PM15523017
          Structured Abstract Available:
          http://www.crd.york.ac.uk/CRDWeb/ShowRecord.asp?View=Full&ID=22004009232
           (accessed 2008 Oct 9).

Observational studies (non-comparative or non-Hintegra®)

9.        Benedetti MG, Leardini A, Romagnoli M, Berti L, Catani F, Giannini S. Functional
          outcome of meniscal-bearing total ankle replacement: a gait analysis study. J Am
          Podiatr Med Assoc 2008;98(1):19-26. PubMed: PM18202330

10.       Schutte BG, Louwerens JW. Short-term results of our first 49 Scandinavian total ankle
          replacements (STAR). Foot Ankle Int 2008;29(2):124-7. PubMed: PM18315965

11.       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):605-9.
          PubMed: PM18450626

12.       Ali MS, Higgins GA, Mohamed M. Intermediate results of Buechel Pappas unconstrained
          uncemented total ankle replacement for osteoarthritis. J Foot Ankle Surg 2007;46(1):16-
          20. PubMed: PM17198948

13.       Fevang BT, Lie SA, Havelin LI, Brun JG, Skredderstuen A, Furnes O. 257 ankle
          arthroplasties performed in Norway between 1994 and 2005. Acta Orthop
          2007;78(5):575-83. PubMed: PM17966015

14.     Henricson A, Skoog A, Carlsson A. The Swedish Ankle Arthroplasty Register: An analysis
        of 531 arthroplasties between 1993 and 2005. Acta Orthop 2007;78(5):569-74. PubMed:
        PM17966014

15.       Hosman AH, Mason RB, Hobbs T, Rothwell AG. A New Zealand national joint registry
          review of 202 total ankle replacements followed for up to 6 years. Acta Orthop
          2007;78(5):584-91. PubMed: PM17966016

16.       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):308-12. PubMed: PM17371654

17.       Valderrabano V, Nigg BM, von Tscharner V, Frank CB, Hintermann B. J. Leonard
          Goldner Award 2006. Total ankle replacement in ankle osteoarthritis: an analysis of
          muscle rehabilitation. Foot Ankle Int 2007;28(2):281-91. PubMed: PM17296155

18.       Conti S, Lalonde KA, Martin R. Kinematic analysis of the agility total ankle during gait.
          Foot Ankle Int 2006;27(11):980-4. PubMed: PM17144964




      Total Ankle Replacements                                                                   7
19.       Doets HC, Brand R, Nelissen RG. Total ankle arthroplasty in inflammatory joint disease
          with use of two mobile-bearing designs. J Bone Joint Surg Am 2006;88(6):1272-84.
          PubMed: PM16757761

20.       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.
          PubMed: PM16487461

21.       Nelissen RG, Doets HC, Valstar ER. Early migration of the tibial component of the
          buechel-pappas total ankle prosthesis. Clin Orthop Relat Res 2006;448:146-51.
          PubMed: PM16826109

22.       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):139-46.
          PubMed: PM16651192

23.       Valderrabano V, Pagenstert G, Horisberger M, Knupp M, Hintermann B. Sports and
          recreation activity of ankle arthritis patients before and after total ankle replacement. Am
          J Sports Med 2006;34(6):993-9. PubMed: PM16452268

24.       van der Heide HJ, Nováková I, de Waal Malefijt MC. The feasibility of total ankle
          prosthesis for severe arthropathy in haemophilia and prothrombin deficiency.
          Haemophilia 2006;12(6):679-82. PubMed: PM17083522

25.       Carlsson A, Markusson P, Sundberg M. Radiostereometric analysis of the double-coated
          STAR total ankle prosthesis: a 3-5 year follow-up of 5 cases with rheumatoid arthritis
          and 5 cases with osteoarthrosis. Acta Orthop 2005;76(4):573-9. PubMed: PM16195076

26.       Murnaghan JM, Warnock DS, Henderson SA. Total ankle replacement. Early
          experiences with STAR prosthesis. Ulster Med J 2005;74(1):9-13. PubMed:
          PM16022128

27.       Anderson T, Montgomery F, Carlsson A. Uncemented STAR total ankle prostheses. J
          Bone Joint Surg Am 2004;86-A Suppl 1(Pt 2):103-11. PubMed: PM15466751

28.       Bonnin M, Judet T, Colombier JA, Buscayret F, Graveleau N, Piriou P. Midterm results
          of the Salto Total Ankle Prosthesis. Clin Orthop Relat Res 2004;(424):6-18. PubMed:
          PM15241138

29.       Knecht SI, Estin M, Callaghan JJ, Zimmerman MB, Alliman KJ, Alvine FG, et al. The
          Agility total ankle arthroplasty. Seven to sixteen-year follow-up. J Bone Joint Surg Am
          2004;86-A(6):1161-71. PubMed: PM15173288

30.       Kofoed H. Scandinavian Total Ankle Replacement (STAR). Clin Orthop Relat Res
          2004;(424):73-9. PubMed: PM15241146

31.       Lodhi Y, McKenna J, Herron M, Stephens MM. Total ankle replacement. Ir Med J
          2004;97(4):104-5. PubMed: PM15200217




      Total Ankle Replacements                                                                    8
32.       McGarvey WC, Clanton TO, Lunz D. Malleolar fracture after total ankle arthroplasty: a
          comparison of two designs. Clin Orthop Relat Res 2004;(424):104-10. PubMed:
          PM15241150

33.       Nagashima M, Takahashi H, Kakumoto S, Miyamoto Y, Yoshino S. Total ankle
          arthroplasty for deformity of the foot in patients with rheumatoid arthritis using the TNK
          ankle system: clinical results of 21 cases. Mod Rheumatol 2004;14(1):48-53. PubMed:
          PM17028805

34.       Spirt AA, Assal M, Hansen ST, Jr. Complications and failure after total ankle
          arthroplasty. J Bone Joint Surg Am 2004;86-A(6):1172-8. PubMed: PM15173289

35.       Valderrabano V, Hintermann B, Dick W. Scandinavian total ankle replacement: a 3.7-
          year average followup of 65 patients. Clin Orthop Relat Res 2004;(424):47-56. PubMed:
          PM15241143

36.       Zerahn B, Kofoed H. Bone mineral density, gait analysis, and patient satisfaction, before
          and after ankle arthroplasty. Foot Ankle Int 2004;25(4):208-14. PubMed: PM15132927

37.       Anderson T, Montgomery F, Carlsson A. Uncemented STAR total ankle prostheses.
          Three to eight-year follow-up of fifty-one consecutive ankles. J Bone Joint Surg Am
          2003;85-A(7):1321-9. PubMed: PM12851358

38.       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):462-72. PubMed: PM12854666

39.       Natens P, Dereymaeker G, Abbara M, Matricali G. Early results after four years
          experience with the S.T.A.R. uncemented total ankle prosthesis. Acta Orthop Belg
          2003;69(1):49-58. PubMed: PM12666291

40.       Wood PL, Deakin S. Total ankle replacement. The results in 200 ankles. J Bone Joint
          Surg Br 2003;85(3):334-41. PubMed: PM12729104

Review articles

41.       Bestic JM, Peterson JJ, Deorio JK, Bancroft LW, Berquist TH, Kransdorf MJ.
          Postoperative evaluation of the total ankle arthroplasty. AJR Am J Roentgenol
          2008;190(4):1112-23. PubMed: PM18356463

42.       Chou LB, Coughlin MT, Hansen S Jr, Haskell A, Lundeen G, Saltzman CL, et al.
          Osteoarthritis of the ankle: the role of arthroplasty. J Am Acad Orthop Surg
          2008;16(5):249-59. PubMed: PM18460685

43.       Cracchiolo A, Deorio JK. Design features of current total ankle replacements: implants
          and instrumentation. J Am Acad Orthop Surg 2008;16(9):530-40. PubMed: PM18768710

44.       Deorio JK, Easley ME. Total ankle arthroplasty. Instr Course Lect 2008;57:383-413.
          PubMed: PM18399599




      Total Ankle Replacements                                                                   9
45.       Guyer AJ, Richardson G. Current concepts review: total ankle arthroplasty. Foot Ankle
          Int 2008;29(2):256-64. PubMed: PM18315988

46.       Image-guided surgery systems for joint replacement. In: HTAIS Health Technology
          Forecast [database online]. Plymouth Meeting (PA): ECRI Institute; 2008 (accessed
          2008 Oct 9).
          Report is available for purchase at www.ecri.org.

47.       Martin RL, Stewart GW, Conti SF. Posttraumatic ankle arthritis: an update on
          conservative and surgical management. J Orthop Sports Phys Ther 2007;37(5):253-9.
          PubMed: PM17549954

48.       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):1056-64. PubMed:
          PM17300976

49.       Wood PL, Crawford LA, Suneja R, Kenyon A. Total ankle replacement for rheumatoid
          ankle arthritis. Foot Ankle Clin 2007;12(3):497-508, vii. PubMed: PM17765841

50.       Lewis G. Biomechanics of and research challenges in uncemented total ankle
          replacement. Clin Orthop Relat Res 2004;(424):89-97. PubMed: PM15241148

51.       Su EP, Kahn B, Figgie MP. Total ankle replacement in patients with rheumatoid arthritis.
          Clin Orthop Relat Res 2004;(424):32-8. PubMed: PM15241141

      Additional references

52.       Haskell A, Mann RA. Perioperative complication rate of total ankle replacement is
          reduced by surgeon experience. Foot Ankle Int 2004;25(5):283-9. PubMed:
          PM15134607

53.       Myerson MS, Mroczek K. Perioperative complications of total ankle arthroplasty. Foot
          Ankle Int 2003;24(1):17-21. PubMed: PM12540076

54.       Saltzman CL, Amendola A, Anderson R, Coetzee JC, Gall RJ, Haddad SL, et al.
          Surgeon training and complications in total ankle arthroplasty. Foot Ankle Int
          2003;24(6):514-8. PubMed: PM12854675




      Total Ankle Replacements                                                                10

								
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