Early Clinical Results of the BOX Ankle Replacement Are Satisfactory: A Multicenter Feasibility Study of 158 Ankles

Abstract

A new design for a 3-part ankle replacement was developed in an effort to achieve compatibility with the naturally occurring ligaments of the ankle by allowing certain fibers to remain isometric during passive motion. In order to test the design concept clinically, 158 prostheses were implanted in 156 patients within a 9-center trial and were followed up for a mean of 17 (range 6 to 48) months. The mean age at the time of surgery was 60.5 (range 29.7 to 82.5) years. Outcome measures included the American Orthopaedic Foot & Ankle Surgery hindfoot-ankle score and range of motion measured on lateral radiographs of the ankle. The preoperative American Orthopaedic Foot & Ankle Surgery score of 36.3 rose to 74.6, 78.6, 76.4, and 79.0, respectively, at 12, 24, 36, and 48 months. A significant correlation between meniscal bearing movement on the tibial component (mean 3.3 mm; range 2 to 11 mm) and range of flexion at the replaced ankle (mean 26.5°; range 14° to 53°) was observed in radiograms at extreme flexions. Two (1.3%) revisions in the second and third postoperative years necessitated component removal (neither were for implant failure), and 7 (4.4%) further secondary operations were required. The results of this investigation demonstrated that non-anatomic–shaped talar and tibial components, with a fully conforming interposed meniscal bearing, can provide safety and efficacy in the short term, although a longer follow-up period is required to more thoroughly evaluate this ankle implant.