Randomised Controlled Trial of the Timing of Full Weight Bearing Walking After Soft Tissue Hallux Valgus Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Hallux Valgus Angle as a Measure of the Radiological Changes
研究概览
简要总结
Investigate the optimal timing for weight bearing after Hallux Valgus surgery. Hypothesis: Early weight bearing does not affect outcome after the Endoscopic Distal Soft Tissue Procedure for Hallux Valgus Correction.
详细描述
Introduction:
- Rehabilitation plans after hallux valgus/bunion surgery is varied
- From a patient's perspective, full weight bearing is paramount for quality of life and return to work/study
- No high-level study showing the optimal time to resume full weight bearing available
Hypothesis:
Early weight bearing (at 2 weeks post-op) does not affect outcome after the Endoscopic Distal Soft Tissue Procedure for Hallux Valgus correction
Trial Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Surgeon blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing the EDSTP recruited
排除标准
- •Cases requiring additional procedures (eg 2nd toe correction)
- •Mental incapacitation
- •Physical disability hindering rehabilitation (eg CVA, neurological disorder)
研究组 & 干预措施
Control Rehab
Follow existing rehabilitation protocol of Non-weight bearing walking for 6 weeks followed by heel walking for 6 weeks; then the resumption of normal full weight-bearing walking in normal shoes at 12 weeks post-operation
Accelerated Rehab
Accelerated rehabilitation protocol of non-weight bearing walking for 2 weeks followed by heel walking for 10 weeks; then the resumption of normal full weight-bearing walking in normal shoes at 12 weeks post-operation
干预措施: Accelerated Rehabilitation plan (Other)
结局指标
主要结局
Hallux Valgus Angle as a Measure of the Radiological Changes
时间窗: 0, 12, 26 weeks post-surgery
Weight bearing feet X-Ray to measure radiological parameters of hallux valgus. A larger angle represents the more severe condition. This is the angle between the 1st metatarsal and the proximal phalanx.
Inter-metatarsal Angle as a Measure of the Radiological Changes
时间窗: 0, 12, 26 weeks post-surgery
Weight bearing feet X-Ray to measure radiological parameters of hallux valgus. A larger angle represents the more severe condition. This is measure using the bisecting line between the 1st metatarsal and the 2nd metatarsal.
Radiological Changes (Tibial Sesamoid Position)
时间窗: 0, 12, 26 weeks post-surgery
Weight bearing feet X-Ray to measure radiological parameters of hallux valgus. 4 represents the most neutral position. bigger difference from 4 means more severe condition. This a score from 0-7.
次要结局
- Foot Function (FAOS ADL)(0, 12, 26 week post-surgery)
- Foot Function (FAOS QoL)(0, 12, 26 week post-surgery)
- Foot Function (FAOS Symptoms)(0, 12, 26 week post-surgery)
- Foot Function (FAOS Pain)(0, 12, 26 week post-surgery)
- Foot Function (FAOS Sport)(0, 12, 26 week post-surgery)
研究者
Samuel KK Ling
Orthopaedic Surgeon
Chinese University of Hong Kong