Co_Leap: Late Compared to Early Physiotherapy Following Knee Dislocation

Sponsor

Unity Health Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT01296750

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

38 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)

Actual Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Sep 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Need for knee manipulation at or within 6months of initial surgery. [6 months]
Manipulation includes: Knee manipulation under anesthesia Arthroscopic debridement of arthrofibrosis Open debridement of arthrofibrosis

Secondary Outcome Measures

Knee Range of Motion [6 months]
Passive Range of Motion
Knee stability [6 months]
Clinical exam of ligament grading
Patient Reported Outcome [6 months]
Multi-Ligament Quality of Life Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8

Sponsors and Collaborators

Unity Health Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Unity Health Toronto

ClinicalTrials.gov Identifier:

NCT01296750

Other Study ID Numbers:

SMH Co_LEAP

First Posted:

Feb 15, 2011

Last Update Posted:

Jan 20, 2021

Last Verified:

Jan 1, 2020

Additional relevant MeSH terms:

Joint Dislocations

Knee Dislocation

Study Results

No Results Posted as of Jan 20, 2021