全踝关节置换与踝关节融合术的临床疗效结果：一项初步随机对照试验。
Clinical outcome results of total ankle replacement and ankle arthrodesis: a pilot randomised controlled trial.
机构信息
Department of Orthopedic Surgery, Queen Elizabeth II Health Sciences Center, 1796 Summer Street, Halifax, Nova Scotia, B3H 3A7, Canada.
Dalhousie University, Division of Orthopedic Surgery, Queen Elizabeth II Health Sciences Center, 1796 Summer Street, Halifax, Nova Scotia, B3H 3A7, Canada.
出版信息
Foot Ankle Surg. 2021 Apr;27(3):326-331. doi: 10.1016/j.fas.2020.10.005. Epub 2020 Oct 17.
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.
背景
踝关节融合术（AA）和置换术（TAA）是治疗终末期踝关节关节炎（ESAA）的广泛接受的选择。我们假设这两种干预措施的临床结果相似。
方法
我们进行了一项多中心随机对照试验，收集了患者人口统计学、并发症发生率、踝关节骨关节炎量表（AOS）和 36 项简短健康调查问卷（SF-36）评分的数据。我们评估了队列内和队列间的术前和术后评分。
结果
39 个踝关节的平均随访时间为 5.1 ± 2.8 年。两组的总 AOS 评分均显著改善；TAA 从 59.4 ± 15.9 分提高到 38 ± 20 分（p 值=0.002），AA 从 64.6 ± 19.7 分提高到 31.8 ± 16.5 分（p 值<0.001）。AA 组的并发症发生率较高，有 4 例严重并发症（20%）。
结论
我们观察到 TAA 和 AA 有统计学上显著的益处。作为一项试点试验，本研究旨在为未来的 RCT 提供设计和可行性方面的信息。
证据水平
II 级。
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