比较立即和延迟的重量轴承在患者的脚开放缩减内部固定-一个可行性随机对照试验的协议随机对照试验
Blare Mason1, Zohreh Jafarian Tangrood2, Jonathan Sharr1
1Division of Orthopaedic Surgery, Christchurch Hospital, Christchurch, New Zealand.
Contemporary clinical trials communications
|June 3, 2024
概括
这项试点研究调查了足骨折手术后的立即与延迟的举重. 立即举重可能是一个可行的和有益的康复策略后开放的减少内部固定 (ORIF).
科学领域:
- 整形外科手术 整形外科手术
- 康复医学 康复医学 康复医学
- 临床试验 临床试验
背景情况:
- 在关节开放缩减内部固定 (ORIF) 后,关于最佳承重时间存在不确定性.
- 传统的六周无重量轴承 (NWB) 协议是常见的,但立即重量轴承 (IWB) 显示了潜在的益处.
- 康复策略在不同的脚骨折模式上有所不同.
研究的目的:
- 评估一项完全随机对照试验 (RCT) 的可行性,该试验将立即减重 (IWB) 与脚ORIF后延迟减重 (DWB) 的比较.
- 为了优化标准康复方案的病人接受脚ORIF.
- 收集有关患者结果和与不同承重协议相关的并发症的初步数据.
主要方法:
- 一项试点随机对照试验 (RCT) 涉及32名手术固定脚骨折的成年参与者.
- 参与者被随机分配到即时举重 (IWB) 组 (24小时内举重) 或延迟举重 (DWB) 组 (NWB六周).
- 收集的数据包括功能评分 (Olerud和Molander,自报告的脚和脚评分,SF-36),返回工作时间,并发症的X光评估. 通过招聘,坚持和学率来评估可行性.
主要成果:
- 这个试点RCT的目的是确定一个更大的研究的可行性.
- 将收集有关患者报告的结果,恢复工作和放射性并发症的数据.
- 将评估可行性指标,如招聘率,执法率和学率.
结论:
- 这项试验性随机对照试验将提供关键数据,以了解关节ORIF后立即承重的可行性.
- 结果将为未来的最终RCT的设计提供信息,以优化康复方案.
- 这项研究旨在确定早期举重是否是足骨折恢复的安全有效组成部分.
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