Early Weightbearing and Mobilization Versus Non-Weightbearing and Immobilization After ORIF of Unstable Ankle Fractures: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Return to work
研究概览
简要总结
The primary objective of the investigators randomized controlled trial is to determine if early protected weightbearing and ankle range of motion after surgical treatment (open reduction internal fixation - ORIF) for ankle fractures improves the rate of return to work and functional outcome compared to postoperative ankle immobilization in a non-weightbearing cast.
详细描述
This is a randomized controlled trial comparing early weightbearing and mobilization VS immobilization and non-weightbearing after initial treatment of unstable ankle fractures.
The primary objective of our randomized control trial is to determine if early protected weightbearing and ankle range of motion post open reduction internal fixation (ORIF) for unstable ankle fractures improves the rate of return to work and functional outcome compared to postoperative ankle immobilization in a non-weightbearing cast.
Our secondary objective is to determine the rate of adverse events (wound healing, infection, hardware failure) with early weightbearing and ROM comparable to rates with traditional post-op ankle immobilization.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral unstable ankle fracture requiring surgical stabilization
- •Treatment within two weeks of injury
- •Closed or low grade open ankle fracture (grade 1 and/or 2)
- •Skeletally mature
排除标准
- •Skeletally immature
- •Previous ipsilateral ankle surgery
- •Bilateral ankle fractures or other major injuries that would affect recovery time
- •Grade 3 open fractures
- •Inability to co-operate with post-op protocol (advanced dementia, polytrauma patient)
- •Non-ambulatory pre injury
- •Tibial plafond fractures including articular impaction requiring elevation
- •Syndesmosis injury requiring fixation
- •Posterior Malleolus fracture - more than 25% of articular surface
研究组 & 干预措施
Non-weightbearing no ROM
Patients will be placed in a back slab post-op and will remain non-weight bearing with crutches with no range of motion for a total of 6 weeks.
After 6 weeks post-op, they will be placed in a boot orthosis and permitted to weight-bear as tolerated.
干预措施: non-weight bearing, no range of motion (Behavioral)
Early weight-bearing and ROM
Patients will be placed in a back slab post-operatively. At 2 weeks post op they will have the back slab removed and placed in a boot orthosis. At this time they will be permitted to weight-bear as tolerated and perform limited ankle range of motion exercises.
After 6 weeks post op they will start to wean from the boot orthosis.
干预措施: Early weight-bearing and range of motion exercises (Behavioral)
结局指标
主要结局
Return to work
时间窗: 3 months
Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work compared to traditional post-op ankle immobilization in a non-weightbearing cast?
次要结局
- Functional outcome and event rate(6 weeks)
- Return to work and functional outcome(12 months)
- Functional outcome and event rate(2 weeks)
- Return to work and functional outcome(9 weeks)
- Return to work and functional outcome(6 months)