Late Compared to Early Physiotherapy Following Knee Dislocation (Co_Leap)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01296750
Recruitment Status : Unknown
Verified February 2011 by St. Michael's Hospital, Toronto.
Recruitment status was:  Recruiting
First Posted : February 15, 2011
Last Update Posted : July 22, 2014
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Traumatic Knee Dislocation Other: Early Physiotherapy start Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing Late Versus Early Physiotherapy Start Times Following Multi Ligament Reconstruction for Knee Dislocation (Co-LEAP)
Study Start Date : June 2011
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dislocations
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Early Physiotherapy
Physiotherapy to begin within 1 day post op.
Other: Early Physiotherapy start
Physiotherapy starting at one day post op
No Intervention: Late Physiotherapy
Physiotherapy to start 6 weeks post op

Primary Outcome Measures :
  1. Need for knee manipulation at or within 6months of initial surgery. [ Time Frame: 6 months ]

    Manipulation includes:

    1. Knee manipulation under anesthesia
    2. Arthroscopic debridement of arthrofibrosis
    3. Open debridement of arthrofibrosis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01296750

Contact: Daniel B. Whelan, MD, MSc 416-864-6002
Contact: Ryan M. Khan, BA, CCRP 416-864-6060 ext 3890

Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Ryan M. Khan, BA, CCRP    416-864-6060 ext 3890   
Principal Investigator: Daniel B. Whelan, MD, MSc         
Sponsors and Collaborators
St. Michael's Hospital, Toronto

Responsible Party: St. Michael's Hospital, Toronto Identifier: NCT01296750     History of Changes
Other Study ID Numbers: SMH Co_LEAP
First Posted: February 15, 2011    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: February 2011

Additional relevant MeSH terms:
Joint Dislocations
Knee Dislocation
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Knee Injuries
Leg Injuries