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Late Compared to Early Physiotherapy Following Knee Dislocation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01296750
Acronym
Co_Leap
Enrollment
38
Registered
2011-02-15
Start date
2011-06-30
Completion date
2018-09-30
Last updated
2021-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Knee Dislocation

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.

Interventions

OTHEREarly Physiotherapy start

Physiotherapy starting at one day post op

Sponsors

Unity Health Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Need for knee manipulation at or within 6months of initial surgery.6 monthsManipulation includes: 1. Knee manipulation under anesthesia 2. Arthroscopic debridement of arthrofibrosis 3. Open debridement of arthrofibrosis

Secondary

MeasureTime frameDescription
Knee Range of Motion6 monthsPassive Range of Motion
Knee stability6 monthsClinical exam of ligament grading
Patient Reported Outcome6 monthsMulti-Ligament Quality of Life Questionnaire

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026