Late Compared to Early Physiotherapy Following Knee Dislocation (Co_Leap)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Traumatic Knee Dislocation |
Other: Early Physiotherapy start |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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) |
- Need for knee manipulation at or within 6months of initial surgery. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Manipulation includes:
- Knee manipulation under anesthesia
- Arthroscopic debridement of arthrofibrosis
- Open debridement of arthrofibrosis
| Estimated Enrollment: | 70 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Daniel B. Whelan, MD, MSc | 416-864-6002 | WhelanD@smh.ca |
| Contact: Ryan M. Khan, BA, CCRP | 416-864-6060 ext 3890 | Khanry@smh.ca |
| Canada, Ontario | |
| St. Michael's Hospital | Not yet recruiting |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Contact: Ryan M. Khan, BA, CCRP 416-864-6060 ext 3890 Khanry@smh.ca | |
| Principal Investigator: Daniel B. Whelan, MD, MSc | |
More Information
No publications provided
| Responsible Party: | Dr. Daniel B. Whelan, St. Michael's Hospital |
| ClinicalTrials.gov Identifier: | NCT01296750 History of Changes |
| Other Study ID Numbers: | SMH Co_LEAP |
| Study First Received: | February 14, 2011 |
| Last Updated: | February 14, 2011 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Dislocations Knee Dislocation Wounds and Injuries Knee Injuries Leg Injuries |
ClinicalTrials.gov processed this record on June 17, 2013