Traumatic Knee DislocationCo_LeapNCT01296750
Late Compared to Early Physiotherapy Following Knee Dislocation
A study testing Early Physiotherapy start in people with Traumatic Knee Dislocation, run by Unity Health Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Traumatic Knee Dislocation
- What is being tested?
- Early Physiotherapy start
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Poly-trauma with life-threatening injuries preventing rehabilitation
- Patients unable to comply with intensive rehabilitation
- Patients unable or unlikely to maintain follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial Comparing Late Versus Early Physiotherapy Start Times Following Multi Ligament Reconstruction for Knee Dislocation (Co-LEAP)
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.
- Conditions
- Traumatic Knee Dislocation
- Being tested
- Early Physiotherapy start
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Physiotherapy startOther
Physiotherapy starting at one day post op
| Study group | Role | What they receive |
|---|---|---|
| Early Physiotherapy | Active comparator | Physiotherapy to begin within 1 day post op. Receives: Other: Early Physiotherapy start |
| Late Physiotherapy | No intervention | Physiotherapy to start 6 weeks post op |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
Knee Range of Motion
Passive Range of Motion
Measured: 6 months
Knee stability
Clinical exam of ligament grading
Measured: 6 months
Patient Reported Outcome
Multi-Ligament Quality of Life Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Knee DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296750
- Sponsor's protocol ID
- SMH Co_LEAP
- Acronym
- Co_Leap
- Status last verified
- Jan 2020
- First submitted
- 14 Feb 2011
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Hoit G, Rubacha M, Chahal J, Khan R, Ravi B, Whelan DB. Is There a Disadvantage to Early Physical Therapy After Multiligament Surgery for Knee Dislocation? A Pilot Randomized Clinical Trial. Clin Orthop Relat Res. 2021 Aug 1;479(8):1725-1736. doi: 10.1097/CORR.0000000000001729.
PubMed 33729214
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Late Versus Early Physiotherapy Start Times Following Multi Ligament Reconstruction for Knee Dislocation (Co-LEAP)
- ClinicalTrials.gov ID
- NCT01296750
- Acronym / sponsor ID
- Co_Leap / SMH Co_LEAP
- Conditions
- Traumatic Knee Dislocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 15 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Physiotherapy | Active comparator | Other: Early Physiotherapy startPhysiotherapy to begin within 1 day post op. |
| Late Physiotherapy | No intervention | –Physiotherapy to start 6 weeks post op |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Poly-trauma with life-threatening injuries preventing rehabilitation
- Patients unable to comply with intensive rehabilitation
- Patients unable or unlikely to maintain follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Physiotherapy startPhysiotherapy starting at one day post op | Other | Early Physiotherapy |
Primary outcome
Need for knee manipulation at or within 6months of initial surgery.
Time frame: 6 months
Manipulation includes: 1. Knee manipulation under anesthesia 2. Arthroscopic debridement of arthrofibrosis 3. Open debridement of arthrofibrosis
3 secondary outcomes
Knee Range of Motion
Time frame: 6 months
Knee stability
Time frame: 6 months
Patient Reported Outcome
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Derived from this study: PubMed 33729214Hoit G, Rubacha M, Chahal J, Khan R, Ravi B, Whelan DB. Is There a Disadvantage to Early Physical Therapy After Multiligament Surgery for Knee Dislocation? A Pilot Randomized Clinical Trial. Clin Orthop Relat Res. 2021 Aug 1;479(8):1725-1736. doi: 10.1097/CORR.0000000000001729.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Physiotherapy start in people with Traumatic Knee Dislocation, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for knee manipulation at or within 6months of initial surgery. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01296750, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.