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