Late Compared to Early Physiotherapy Following Knee Dislocation (Co_Leap)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2011 by St. Michael's Hospital, Toronto
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01296750
First received: February 14, 2011
Last updated: July 21, 2014
Last verified: February 2011
  Purpose

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 Intervention Phase
Traumatic Knee Dislocation
Other: Early Physiotherapy start
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Need for knee manipulation at or within 6months of initial surgery. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Manipulation includes:

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


Estimated Enrollment: 70
Study Start Date: June 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296750

Contacts
Contact: Daniel B. Whelan, MD, MSc 416-864-6002 WhelanD@smh.ca
Contact: Ryan M. Khan, BA, CCRP 416-864-6060 ext 3890 Khanry@smh.ca

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

No publications provided

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01296750     History of Changes
Other Study ID Numbers: SMH Co_LEAP
Study First Received: February 14, 2011
Last Updated: July 21, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Dislocations
Knee Dislocation
Wounds and Injuries
Knee Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 21, 2014