跳至主要内容
临床试验/NCT01296750
NCT01296750已完成不适用

A Randomized Clinical Trial Comparing Late Versus Early Physiotherapy Start Times Following Multi Ligament Reconstruction for Knee Dislocation (Co-LEAP)

Unity Health Toronto1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2011年6月1日最近更新:
适应症
干预措施

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

Active Comparator

Physiotherapy to begin within 1 day post op.

干预措施: Early Physiotherapy start (Other)

Late Physiotherapy

No Intervention

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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