Late Compared to Early Physiotherapy Following Knee Dislocation (Co_Leap)

January 15, 2021 updated by: Unity Health Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2011

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (Estimate)

February 15, 2011

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMH Co_LEAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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