Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-27 @ 1:05 AM
Study NCT ID:
NCT01296750
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2011-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Late Compared to Early Physiotherapy Following Knee Dislocation
Sponsor:
Unity Health Toronto
Organization:
Study Overview
Official Title:
A Randomized Clinical Trial Comparing Late Versus Early Physiotherapy Start Times Following Multi Ligament Reconstruction for Knee Dislocation (Co-LEAP)
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Co_Leap
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: