Late Compared to Early Physiotherapy Following Knee Dislocation

Traumatic Knee Dislocation Clinical Trial

— Co_Leap  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296750
• Other study ID #: SMH Co_LEAP
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: September 2018

Study information

• Verified date: January 2020
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Dislocation
• Traumatic Knee Dislocation

Intervention

Other:
• Early Physiotherapy start
Physiotherapy starting at one day post op

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for knee manipulation at or within 6months of initial surgery.	Manipulation includes: Knee manipulation under anesthesia; Arthroscopic debridement of arthrofibrosis; Open debridement of arthrofibrosis	6 months
Secondary	Knee Range of Motion	Passive Range of Motion	6 months
Secondary	Knee stability	Clinical exam of ligament grading	6 months
Secondary	Patient Reported Outcome	Multi-Ligament Quality of Life Questionnaire	6 months