Late Compared to Early Physiotherapy Following Knee Dislocation

Study Overview
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Brief Summary
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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.

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

Conditions
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Traumatic Knee Dislocation

Intervention / Treatment
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* Other: Early Physiotherapy start


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Poly-trauma with life-threatening injuries preventing rehabilitation Patients unable to comply with intensive rehabilitation Patients unable or unlikely to maintain follow-up

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early Physiotherapy<br>Physiotherapy to begin within 1 day post op. | Other: Early Physiotherapy start<br>* Physiotherapy starting at one day post op<br>|
| No Intervention: Late Physiotherapy<br>Physiotherapy to start 6 weeks post op | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for knee manipulation at or within 6months of initial surgery. | Manipulation includes: Knee manipulation under anesthesia Arthroscopic debridement of arthrofibrosis Open debridement of arthrofibrosis | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Range of Motion | Passive Range of Motion | 6 months | 
| Knee stability | Clinical exam of ligament grading | 6 months | 
| Patient Reported Outcome | Multi-Ligament Quality of Life Questionnaire | 6 months |