A Randomized Clinical Trial Comparing Late Versus Early Physiotherapy Start Times Following Multi Ligament Reconstruction for Knee Dislocation (Co-LEAP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Need for knee manipulation at or within 6months of initial surgery.
研究概览
简要总结
A knee dislocation is an unusual and extremely serious injury and is defined as complete displacement of the tibia with respect to the femur, usually with disruption of 3 or more of the stabilizing ligaments. When the knee dislocates, there is often significant damage to the soft-tissues envelope surrounding the joint, including adjacent neurovascular structures. Not surprisingly, this injury is a profoundly debilitating, life-altering event, with the potential to necessitate career change in athletes and laborers alike. Current evidence indicates that operative management for these injuries is more effective at returning patients to pre-morbid range of motion (ROM) and activity than conservative management. Post operative rehabilitation programs for these patients must balance the need for stability of their surgical repair and knee ROM and functionality. Experimental data suggests that post-operative immobilization offers greater protection of the surgical reconstruction, whereas immediate, aggressive physiotherapy may be more effective at preventing arthrofibrosis stiffness. The investigators are proposing a randomized clinical trial comparing early physiotherapy (day one post op) versus immobilization for three weeks then initiation of physiotherapy. The physiotherapy progams will be identicalbe in all aspects except for progam initiation.
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 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulation without aids in pre-morbid condition
- •Multi-ligament knee injury with or without associated peri-articular fracture
- •Operative management within three weeks of the injury
排除标准
- •Poly-trauma with life-threatening injuries preventing rehabilitation
- •Patients unable to comply with intensive rehabilitation
- •Patients unable or unlikely to maintain follow-up
研究组 & 干预措施
Early Physiotherapy
Physiotherapy to begin within 1 day post op.
干预措施: Early Physiotherapy start (Other)
Late Physiotherapy
Physiotherapy to start 6 weeks post op
结局指标
主要结局
Need for knee manipulation at or within 6months of initial surgery.
时间窗: 6 months
Manipulation includes: 1. Knee manipulation under anesthesia 2. Arthroscopic debridement of arthrofibrosis 3. Open debridement of arthrofibrosis
次要结局
- Patient Reported Outcome(6 months)
- Knee Range of Motion(6 months)
- Knee stability(6 months)
