Skip to main content
Log in

Total Ankle Replacement Compatible with Ligament Function Produces Mobility, Good Clinical Scores, and Low Complication Rates: An Early Clinical Assessment

  • Clinical Research
  • Published:
Clinical Orthopaedics and Related Research®

Abstract

Background

A three-part ankle replacement was developed to achieve compatibility with the natural ligaments by allowing fibers on the medial and lateral sides to remain isometric during passive motion. Unlike all current prostheses, the new design uses nonanatomically shaped components on the tibia and talus and a fully conforming interposed meniscal bearing.

Questions/purposes

Does this new design restore ankle mobility, improve clinical score, and result in low complication and early revision rates?

Patients and Methods

We reviewed 51 patients in whom 51 prostheses were implanted in a seven-center trial from July 2003 to July 2006. The mean age of the patients at surgery was 61.5 years (range, 35.1–82.5 years). We used the AOFAS score to assess clinical outcome. We used lateral radiographs to assess function. The minimum followup was 24 months (mean, 30 months; range, 24–48 months).

Results

The mean preoperative AOFAS score of 38.5 increased to 76.9, 79.1, 76.4, and 79.0 at 12, 24, 36, and 48 months, respectively. We observed a correlation between meniscal bearing movement on the tibial component (mean, 3.4 mm; range, 2–12 mm) and range of flexion at the replaced ankle (mean, 27.4º; range, 16º–53º). We revised one arthroplasty in the second postoperative year for lateral impingement, providing a 3-year cumulative survival rate of 97% and performed one other secondary operation for hindfoot pain.

Conclusions

These data suggest the new prosthesis can provide short-term restoration of ankle mobility, a good clinical score, and low complication and failure rates. Longer followup with larger numbers is required.

Level of Evidence

Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4A–B
Fig. 5
Fig. 6
Fig. 7

Similar content being viewed by others

References

  1. Affatato S, Leardini A, Leardini W, Giannini S, Viceconti M. Meniscal wear at a three-component total ankle prosthesis by a knee joint simulator. J Biomech. 2007;40:1871–1876.

    Article  CAS  PubMed  Google Scholar 

  2. Affatato S, Taddei P, Leardini A, Giannini S, Spinelli M, Viceconti M. Wear behaviour in total ankle replacement: a comparison between an in vitro simulation and retrieved prostheses. Clin Biomech (Bristol, Avon). 2009;24:661–669.

    Article  CAS  Google Scholar 

  3. 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;85:1321–1329.

    PubMed  Google Scholar 

  4. Armitage P, Berry G. Statistical Methods in Medical Research. Oxford, England: Blackwell Scientific Publications; 1994.

    Google Scholar 

  5. Bauer G, Eberhardt O, Rosenbaum D, Claes L. Total ankle replacement: review and critical analysis of the current status. Foot Ankle Surg. 1996;2:119–126.

    Article  Google Scholar 

  6. 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.

    Article  PubMed  Google Scholar 

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

    PubMed  Google Scholar 

  8. Calderale PM, Garro A, Barbiero R, Fasolio G, Pipino F. Biomechanical design of the total ankle prosthesis. Eng Med. 1983;12:69–80.

    Article  CAS  PubMed  Google Scholar 

  9. Chou LB, Coughlin MT, Hansen S Jr, Haskell A, Lundeen G, Saltzman CL, Mann RA. Osteoarthritis of the ankle: the role of arthroplasty. J Am Acad Orthop Surg. 2008;16:249–259.

    PubMed  Google Scholar 

  10. Conti SF, Wong YS. Complications of total ankle replacement. Clin Orthop Relat Res. 2001;391:105–114.

    Article  PubMed  Google Scholar 

  11. Corazza F, Stagni R, Castelli VP, Leardini A. Articular contact at the tibiotalar joint in passive flexion. J Biomech. 2005;38:1205–1212.

    Article  PubMed  Google Scholar 

  12. Cracchiolo A 3rd, Deorio JK. Design features of current total ankle replacements: implants and instrumentation. J Am Acad Orthop Surg. 2008;16:530–540.

    PubMed  Google Scholar 

  13. Deorio JK, Easley ME. Total ankle arthroplasty. Instr Course Lect. 2008;57:383–413.

    PubMed  Google Scholar 

  14. Easley ME, Vertullo CJ, Urban WC, Nunley JA. Total ankle arthroplasty. J Am Acad Orthop Surg. 2002;10:157–167.

    PubMed  Google Scholar 

  15. Fevang BT, Lie SA, Havelin LI, Brun JG, Skredderstuen A, Furnes O. 257 ankle arthroplasties in Norway between 1994 and 2005. Acta Orthop. 2007;78:575–583.

    Article  PubMed  Google Scholar 

  16. Freeman MA. Current state of total joint replacement. Br Med J. 1976;2:1301–1304.

    Article  CAS  PubMed  Google Scholar 

  17. Giannini S, Leardini A, O’Connor JJ. Total ankle replacement: review of the designs and of the current status. Foot Ankle Surg. 2000;6:77–88.

    Article  Google Scholar 

  18. Giannini S, Vannini F, Faldini C, Bevoni R, Nanni M, Leonetti D. The minimally invasive hallux valgus. Interactive Surgery. 2007;2:17–23.

    Article  Google Scholar 

  19. Gougoulias NE, Khanna A, Maffulli N. History and evolution in total ankle arthroplasty. Br Med Bull. 2009;89:111–151.

    Article  PubMed  Google Scholar 

  20. Gould JS, Alvine FG, Mann RA, Sanders RW, Walling AK. Total ankle replacement: a surgical discussion. Part I: replacement systems, indications, and contraindications. Am J Orthop. 2000;29:604–609.

    CAS  PubMed  Google Scholar 

  21. Gould JS, Alvine FG, Mann RA, Sanders RW, Walling AK. Total ankle replacement: a surgical discussion. Part II: the clinical and surgical experience. Am J Orthop. 2000;29:675–682.

    CAS  PubMed  Google Scholar 

  22. Guyer AJ, Richardson G. Current concepts review: total ankle arthroplasty. Foot Ankle Int. 2008;29:256–264.

    Article  PubMed  Google Scholar 

  23. 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;89:1899–1905.

    Article  CAS  PubMed  Google Scholar 

  24. Henricson A, Skoog A, Carlsson A. The Swedish Ankle Arthroplasty Register: an analysis of 531 arthroplasties between 1993 and 2005. Acta Orthop. 2007;78:569–574.

    Article  PubMed  Google Scholar 

  25. 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.

    Article  PubMed  Google Scholar 

  26. Hosman AH, Mason RB, Hobbs T, Rothwell AG. A New Zealand national joint registry review of 202 total ankle replacements followed up for up to 6 years. Acta Orthop. 2007;78:584–591.

    Article  PubMed  Google Scholar 

  27. Ingrosso S, Benedetti MG, Leardini A, Casanelli S, Sforza T, Giannini S. Gait analysis in patients operated with a novel total ankle prosthesis. Gait Posture. 2009;30:132–137.

    Article  CAS  PubMed  Google Scholar 

  28. Kempson GE, Freeman MA, Tuke MA. Engineering considerations in the design of an ankle joint. Biomed Eng. 1975;10:166–171, 180.

    CAS  PubMed  Google Scholar 

  29. Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994;15:349–353.

    CAS  PubMed  Google Scholar 

  30. Kofoed H. Scandinavian Total Ankle Replacement (STAR). Clin Orthop Relat Res. 2004;424:73–79.

    Article  PubMed  Google Scholar 

  31. Kofoed HA, Sorensen TS. Ankle arthroplasty for rheumatoid arthritis and osteoarthritis: prospective long-term study of cemented replacements. J Bone Joint Surg Br. 1998;80:328–332.

    Article  CAS  PubMed  Google Scholar 

  32. Lachiewicz PF. Total ankle arthroplasty: indications, techniques, and results. Orthop Rev. 1994;23:315–320.

    CAS  PubMed  Google Scholar 

  33. Leardini A, Catani F, Giannini S, O’Connor JJ. Computer-assisted design of the sagittal shapes of a ligament-compatible total ankle replacement. Med Biol Eng Comp. 2001;39:168–175.

    Article  CAS  Google Scholar 

  34. Leardini A, Moschella D. Dynamic simulation of the natural and replaced human ankle joint. Med Biol Eng Comp. 2002;40:193–199.

    Article  CAS  Google Scholar 

  35. Leardini A, O’Connor JJ. A model for lever-arm length calculation of the flexor and extensor muscles at the ankle. Gait Posture. 2002;15:220–229.

    Article  PubMed  Google Scholar 

  36. Leardini A, O’Connor JJ, Catani F, Giannini S. A geometric model of the human ankle joint. J Biomech. 1999;32:585–591.

    Article  CAS  PubMed  Google Scholar 

  37. Leardini A, O’Connor JJ, Catani F, Giannini S. Kinematics of the human ankle complex in passive flexion: a single degree of freedom system. J Biomech. 1999;32:111–118.

    Article  CAS  PubMed  Google Scholar 

  38. Leardini A, O’Connor JJ, Catani F, Giannini S. Mobility of the human ankle and the design of total ankle replacement. Clin Orthop Relat Res. 2004;424:39–46.

    Article  PubMed  Google Scholar 

  39. Michael JM, Golshani A, Gargac S, Goswami T. Biomechanics of the ankle joint and clinical outcomes of total ankle replacement. J Mech Behav Biomed Mater. 2008;1:276–294.

    Article  PubMed  Google Scholar 

  40. Natens P, Dereymaeker G, Abbara M, Matricali G. Early results after four years experience with the STAR uncemented total ankle prosthesis. Acta Orthop Belg. 2003;69:49–58.

    PubMed  Google Scholar 

  41. Neufeld SK, Lee TH. Total ankle arthroplasty: indications, results, and biomechanical rationale. Am J Orthop (Belle Mead NJ). 2000;29:593–602.

    CAS  Google Scholar 

  42. 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;80:1410–1420.

    CAS  PubMed  Google Scholar 

  43. Reggiani B, Leardini A, Corazza F, Taylor M. Finite element analysis of a total ankle replacement during the stance phase of gait. J Biomech. 2006;39:1435–1443.

    Article  CAS  PubMed  Google Scholar 

  44. Rush J. Management of the rheumatoid ankle and hindfoot. Curr Orthop. 1996;10:174–178.

    Article  Google Scholar 

  45. Saltzman CL, McIff TE, Buckwalter JA, Brown TD. Total ankle replacement revisited. J Orthop Sports Phys Ther. 2000;30:56–67.

    CAS  PubMed  Google Scholar 

  46. SooHoo NF, Zingmond DS, Ko CY. Comparison of reoperation rates following ankle arthrodesis and total ankle arthroplasty. J Bone Joint Surg Am. 2007;89:2143–2149.

    Article  PubMed  Google Scholar 

  47. Stagni R, Leardini A, Ensini A. Ligament fibre recruitment at the human ankle joint complex in passive flexion. J Biomech. 2004;37:1823–1829.

    Article  PubMed  Google Scholar 

  48. 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;125:109–119.

    Article  PubMed  Google Scholar 

  49. Vickerstaff JA, Miles AW, Cunningham JL. A brief history of total ankle replacement and a review of the current status. Med Eng Phys. 2007;29:1056–1064.

    Article  PubMed  Google Scholar 

  50. Wood PL, Clough TM, Smith R. The present state of ankle arthroplasty. Foot Ankle Surg. 2008;14:115–119.

    Article  PubMed  Google Scholar 

  51. Wood PL, Crawford LA, Suneja R, Kenyon A. Total ankle replacement for rheumatoid ankle arthritis. Foot Ankle Clin. 2007;12:497–508, vii.

    Article  PubMed  Google Scholar 

  52. Wood PL, Deakin S. Total ankle replacement: the results in 200 ankles. J Bone Joint Surg Br. 2003;85:334–341.

    Article  CAS  PubMed  Google Scholar 

  53. Wood PL, Sutton C, Mishra V, Suneja R. A randomised, controlled trial of two mobile-bearing total ankle replacements. J Bone Joint Surg Br. 2009;91:69–74.

    CAS  PubMed  Google Scholar 

  54. Younger A, Penner M, Wing K. Mobile-bearing total ankle arthroplasty. Foot Ankle Clin. 2008;13:495–508, ix–x.

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

We acknowledge the contribution of clinical data from Livio Nogarin (Mantova), Bruno Magnan (Verona), Leo Massari (Ferrara), Marco Guelfi (Novara), and Antonio Volpe (Abano Terme). We are grateful to Adler Ortho srl (Bologna, Italy) for support in arranging communication and data collection among the centers and to Mike Tuke and Rob Wozencroft for cooperation in the development of components and instruments. We also acknowledge the statistical analysis performed by Barbara Bordini of the IOR and the advice of Dr John Bithell of St Peter’s College, Oxford.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Alberto Leardini DPhil.

Additional information

The Istituto Ortopedico Rizzoli and one of the authors (JJO) have a licensing arrangement with the company producing the prosthesis, under which they receive royalties.

Each clinician in the list of authors certifies that his or her institution approved the human protocol for this investigation, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained.

The design and development work were performed at Istituto Ortopedico Rizzoli, Bologna, Italy, at Oxford Orthopaedic Engineering Centre, Oxford, UK, and Finsbury Orthopaedic Ltd, Leatherhead, UK. The surgery and clinical examinations took place at Bologna and at the six other hospitals listed in the Acknowledgments. Data analysis was performed at Bologna.

About this article

Cite this article

Giannini, S., Romagnoli, M., O’Connor, J.J. et al. Total Ankle Replacement Compatible with Ligament Function Produces Mobility, Good Clinical Scores, and Low Complication Rates: An Early Clinical Assessment. Clin Orthop Relat Res 468, 2746–2753 (2010). https://doi.org/10.1007/s11999-010-1432-3

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11999-010-1432-3

Keywords

Navigation