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Clinical outcome results of total ankle replacement and ankle arthrodesis: a pilot randomised controlled trial.
Foot and Ankle Surgery : Official Journal of the European Society of Foot and Ankle Surgeons 2020 October 18
BACKGROUND: Ankle arthrodesis (AA) and replacement (TAA) are widely accepted options in managing end-stage ankle arthritis (ESAA). We hypothesize that clinical outcomes would be similar for both interventions.
METHODS: We conducted a multicenter randomized controlled trial that collected data on patient demographics, complication rates, Ankle Osteoarthritis Scale (AOS) and Short Form-36 (SF-36) scores. We evaluated pre and postoperative scores within and between cohorts.
RESULTS: The thirty-nine ankles enrolled had a mean follow-up of 5.1 ± 2.8 years. Total AOS scores improved significantly in both groups; 59.4 ± 15.9 to 38 ± 20 (p-value = 0.002) for TAA and 64.6 ± 19.7 to 31.8 ± 16.5 (p-value < 0.001) for AA at last follow-up. Complication rate was higher in the AA cohort with four major complications (20%).
CONCLUSION: We observed a statistically significant benefit with TAA and AA. As a pilot trial, this study is meant to inform on design and feasibility of future RCTs.
LEVEL OF EVIDENCE: II.
METHODS: We conducted a multicenter randomized controlled trial that collected data on patient demographics, complication rates, Ankle Osteoarthritis Scale (AOS) and Short Form-36 (SF-36) scores. We evaluated pre and postoperative scores within and between cohorts.
RESULTS: The thirty-nine ankles enrolled had a mean follow-up of 5.1 ± 2.8 years. Total AOS scores improved significantly in both groups; 59.4 ± 15.9 to 38 ± 20 (p-value = 0.002) for TAA and 64.6 ± 19.7 to 31.8 ± 16.5 (p-value < 0.001) for AA at last follow-up. Complication rate was higher in the AA cohort with four major complications (20%).
CONCLUSION: We observed a statistically significant benefit with TAA and AA. As a pilot trial, this study is meant to inform on design and feasibility of future RCTs.
LEVEL OF EVIDENCE: II.
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