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Weight bearing or non-weight bearing after surgically fixed ankle fractures, the WOW! Study: Study protocol for a randomized controlled trial

机译:外科固定踝关节骨折后负重或不负重,哇!研究:随机对照试验的研究方案

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摘要

Background The optimal post-operative care regimen after surgically fixed Lauge Hansen supination exorotation injuries remains to be established. This study compares whether unprotected weight bearing as tolerated is superior to protected weight bearing and unprotected non-weight bearing in terms of functional outcome and safety. Methods/Design The WOW! Study is a prospective multicenter clinical trial. Patients between 18 and 65 years of age with a Lauge Hansen supination exorotation type 2, 3 or 4 ankle fractures requiring surgical treatment are eligible for inclusion. An expert panel validates the classification and inclusion eligibility. After surgery, patients are randomized to either the 1) unprotected non-weight-bearing, 2) protected weight-bearing, or 3) unprotected weight-bearing group. The primary outcome measure is ankle-specific disability measured by the Olerud-Molander ankle score. Secondary outcomes are 1) quality of life (e.g., return to work and resumption of sport), 2) complications, 3) range of motion, 4) calf wasting, and 5) maximum pressure load after 3 months and 1 year. Discussion This trial is designed to compare the effectiveness and safety of unprotected weight bearing with two commonly used post-operative treatment regimens after internal fixation of specified, intrinsically stable but displaced ankle fractures. An expert panel has been established to evaluate every potential subject, which ensures that every patient is strictly screened according to the inclusion and exclusion criteria and that there is a clear indication for surgical fixation. Keywords: Ankle, Ankle fracture, Lauge Hansen, Post-operative care regimen, Weight bearing
机译:背景技术尚待确定手术修复劳格·汉森(Lauge Hansen)旋后拔除伤后的最佳术后护理方案。这项研究比较了在功能结果和安全性方面,无保护的负重承受能力是否优于受保护的负重和不受保护的无负重。方法/设计哇!研究是一项前瞻性的多中心临床试验。年龄在18至65岁之间,需要进行手术治疗且患有Lauge Hansen旋后,2、3或4种踝关节骨折的患者符合入选条件。专家小组将验证分类和纳入资格。手术后,将患者随机分为1)无保护的非负重,2)受保护的负重或3)无保护的负重组。主要结局指标是通过Olerud-Molander踝关节评分测量的特定于踝关节的残疾。次要结果是1)生活质量(例如重返工作岗位和恢复运动),2)并发症,3)运动范围,4)小腿消瘦和5)3个月零一年后的最大压力负荷。讨论本试验旨在比较内部固定的固有稳定但移位的踝部骨折后,采用两种常用的术后治疗方案比较无保护负重的有效性和安全性。已经建立了一个专家小组来评估每个潜在的受试者,以确保严格按照纳入和排除标准对每个患者进行筛查,并明确指出手术固定的指征。关键词:踝关节踝关节骨折Lauge Hansen术后护理方案负重

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