Trauma and Orthopaedic Research Unit, Canberra Hospital, Building 6 Level 1, PO Box Woden ACT, Canberra, 2606, Australia.
Australian National University Medical School, Level 2 Peter Baume Building 42, Linneaus Way, Canberra, 0200, Australia.
BMC Musculoskelet Disord. 2021 Sep 8;22(1):766. doi: 10.1186/s12891-021-04644-4.
It is controversial whether or not the carpometacarpal joint (CMCJ) should be included in total wrist arthrodesis (TWA). Complications commonly occur at this site and studies examining its inclusion and exclusion are conflicting. A randomised clinical trial comparing wrist arthrodesis with CMCJ arthrodesis and spanning plate to wrist arthrodesis with CMCJ preservation and non-CMCJ spanning plate has not been performed.
A single centre randomised clinical trial including 120 adults with end-stage isolated wrist arthritis will be performed to compare TWA with and without the CMCJ included in the arthrodesis. The primary outcome is complications in the first post-operative year. Secondary outcomes are Disabilities of the Arm, Shoulder and Hand (DASH) score, Patient Rated Wrist Evaluation (PRWE) and grip strength measured at 1, 2 and 5 years. Late complications, return to work and satisfaction will also be recorded.
It is unknown whether the CMCJ should be included in TWA. This trial will contribute to an improved understanding of optimal management of the CMCJ in total wrist arthrodesis.
This trial was prospectively registered with the Australia New Zealand Clinical Trials Registry with identifying number ACTRN12621000169842 on the 16th February 2021. WHO: U1111-12626523.
ACTRN12621000169842.
掌腕关节(CMCJ)是否应包括在全腕关节融合术(TWA)中存在争议。该部位常发生并发症,且研究对其包含和排除的结果存在争议。尚未进行比较包含或不包含 CMCJ 融合术以及跨关节板的腕关节融合术与仅行 CMCJ 保留和非 CMCJ 跨关节板的腕关节融合术的随机临床试验。
将开展一项单中心随机临床试验,纳入 120 例终末期孤立性腕关节炎成人患者,比较 TWA 联合和不联合 CMCJ 融合术的效果。主要结局为术后 1 年内的并发症。次要结局为上肢功能障碍(DASH)评分、患者自评腕关节评估(PRWE)和 1、2、5 年时的握力。还将记录迟发性并发症、重返工作岗位和满意度。
目前尚不清楚 CMCJ 是否应包括在 TWA 中。该试验将有助于更好地了解 TWA 中 CMCJ 的最佳处理方法。
该试验于 2021 年 2 月 16 日前瞻性地在澳大利亚和新西兰临床试验注册中心注册,注册号为 ACTRN12621000169842。注册号:U1111-12626523。
ACTRN12621000169842。