Background:This multicenter prospective cohort study assessed the safety and performance of the Trabecular Metal Total Ankle System (TM Ankle; Zimmer) for primary total ankle arthroplasty (TAA).Methods:One hundred and twenty-one consecutive patients qualifying for primary TAA were enrolled in the study. All patients received the TM Ankle implant. Clinical outcome examinations and radiographic evaluations were conducted at 6 weeks, 6 months, 1 year, 2 years, and 3 years. Patient-reported outcome measures (PROMs) were evaluated with use of the EuroQol-5 Dimensions questionnaire (EQ-5D), Ankle Osteoarthritis Scale (AOS), American Orthopaedic Foot & Ankle Society questionnaire (AOFAS), and patient satisfaction at each time point. Complications were classified according to the Canadian Orthopaedic Foot and Ankle Society (COFAS) system.Results:The average AOFAS, EQ-5D, AOS pain, and AOS difficulty scores showed significant improvement at 6 weeks, 6 months, 1 year, 2 years, and 3 years as compared with the preoperative baseline (p < 0.001). The Kaplan-Meier survival estimate for revision when used in primary cases was 97.35% at 3 years. During the 3 years of follow-up, 9 patients showed abnormal radiographic findings. Two ankles had intraoperative complications, 38 had complications that were non-surgical or device-related, and 3 ankles underwent revision.Conclusions:The results of the present study indicated that patient well-being significantly increased following TAA with use of the TM Ankle. Radiographic parameters also demonstrated a low incidence of abnormal findings.Level of Evidence:Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Fixed-Bearing Trabecular Metal Total Ankle Arthroplasty Using the Transfibular Approach for End-Stage Ankle Osteoarthritis: An International Non-Designer Multicenter Prospective Cohort Study / R. D'Ambrosi, H.T. Tiusanen, J.K. Ellington, F. Kraus, A. Younger, F.G. Usuelli. - In: JB & JS OPEN ACCESS. - ISSN 2472-7245. - 7:3(2022), pp. e21.00143.1-e21.00143.8. [10.2106/JBJS.OA.21.00143]

Fixed-Bearing Trabecular Metal Total Ankle Arthroplasty Using the Transfibular Approach for End-Stage Ankle Osteoarthritis: An International Non-Designer Multicenter Prospective Cohort Study

R. D'Ambrosi
Primo
;
2022

Abstract

Background:This multicenter prospective cohort study assessed the safety and performance of the Trabecular Metal Total Ankle System (TM Ankle; Zimmer) for primary total ankle arthroplasty (TAA).Methods:One hundred and twenty-one consecutive patients qualifying for primary TAA were enrolled in the study. All patients received the TM Ankle implant. Clinical outcome examinations and radiographic evaluations were conducted at 6 weeks, 6 months, 1 year, 2 years, and 3 years. Patient-reported outcome measures (PROMs) were evaluated with use of the EuroQol-5 Dimensions questionnaire (EQ-5D), Ankle Osteoarthritis Scale (AOS), American Orthopaedic Foot & Ankle Society questionnaire (AOFAS), and patient satisfaction at each time point. Complications were classified according to the Canadian Orthopaedic Foot and Ankle Society (COFAS) system.Results:The average AOFAS, EQ-5D, AOS pain, and AOS difficulty scores showed significant improvement at 6 weeks, 6 months, 1 year, 2 years, and 3 years as compared with the preoperative baseline (p < 0.001). The Kaplan-Meier survival estimate for revision when used in primary cases was 97.35% at 3 years. During the 3 years of follow-up, 9 patients showed abnormal radiographic findings. Two ankles had intraoperative complications, 38 had complications that were non-surgical or device-related, and 3 ankles underwent revision.Conclusions:The results of the present study indicated that patient well-being significantly increased following TAA with use of the TM Ankle. Radiographic parameters also demonstrated a low incidence of abnormal findings.Level of Evidence:Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
Settore MED/33 - Malattie Apparato Locomotore
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/946758
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