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OpenTrials
Completed

NCT Number: NCT01296750

Late Compared to Early Physiotherapy Following Knee Dislocation

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Physiotherapy start

Other

Physiotherapy starting at one day post op

Primary outcomes

  1. Need for knee manipulation at or within 6months of initial surgery.

    Time frame: 6 months

    Manipulation includes:

    • Knee manipulation under anesthesia
    • Arthroscopic debridement of arthrofibrosis
    • Open debridement of arthrofibrosis

Secondary outcomes

  1. Knee Range of Motion

    Time frame: 6 months

    Passive Range of Motion

  2. Knee stability

    Time frame: 6 months

    Clinical exam of ligament grading

  3. Patient Reported Outcome

    Time frame: 6 months

    Multi-Ligament Quality of Life Questionnaire

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

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

Acronym: Co_Leap

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Feb 15, 2011
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.