Immediate Protected Weight Bearing Versus Conventional Non-Weight Bearing After Surgical Fixation of Unstable Ankle Fractures: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Olerud-Molander Ankle Score (OMAS).
研究概览
简要总结
This prospective randomized controlled trial evaluates the safety and effectiveness of immediate protected weight bearing following surgical fixation of unstable ankle fractures. Participants are randomized to immediate protected weight bearing from the first postoperative day using a Walker boot and crutches or conventional non-weight bearing for six weeks. Functional outcome (OMAS), pain (VAS), ankle range of motion, quality of life (SF-12), and postoperative complications are assessed over 12 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unstable ankle fracture requiring ORIF.
- •Written informed consent.
排除标准
- •Psychiatric disorder.
- •Pre-existing mobility limitation.
- •Cognitive impairment.
- •BMI >30 kg/m².
- •Poorly controlled type 2 diabetes.
- •Soft tissue injury requiring external fixation.
- •Gustilo II/III open fractures.
- •Unstable fixation.
- •Refusal/inability to consent or allow anonymized data use.
- •Any condition compromising safety or validity.
研究组 & 干预措施
Immediate protected weight bearing
Immediate protected weight bearing from postoperative day 1 using a Walker boot and crutches plus standardized rehabilitation
干预措施: Immediate protected weight bearing (Other)
Immediate protected weight bearing
Immediate protected weight bearing from postoperative day 1 using a Walker boot and crutches plus standardized rehabilitation
干预措施: Rehabilitation (Other)
Conventional treatment
Conventional non-weight bearing for 6 weeks followed by progressive weight bearing plus standardized rehabilitation
干预措施: Rehabilitation (Other)
结局指标
主要结局
Olerud-Molander Ankle Score (OMAS).
时间窗: 6 weeks, 12 weeks, 6 months and 12 months after surgery
次要结局
- Visual Analogic Scale (VAS) for pain(6 weeks, 12 weeks, 6 months and 12 months.)
- SF-12 quality of life(6 weeks, 12 weeks, 6 months and 12 months.)