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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2011-02-14', 'studyFirstSubmitQcDate': '2011-02-14', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for knee manipulation at or within 6months of initial surgery.', 'timeFrame': '6 months', 'description': 'Manipulation includes:\n\n1. Knee manipulation under anesthesia\n2. Arthroscopic debridement of arthrofibrosis\n3. Open debridement of arthrofibrosis'}], 'secondaryOutcomes': [{'measure': 'Knee Range of Motion', 'timeFrame': '6 months', 'description': 'Passive Range of Motion'}, {'measure': 'Knee stability', 'timeFrame': '6 months', 'description': 'Clinical exam of ligament grading'}, {'measure': 'Patient Reported Outcome', 'timeFrame': '6 months', 'description': 'Multi-Ligament Quality of Life Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Traumatic Knee Dislocation']}, 'referencesModule': {'references': [{'pmid': '33729214', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ambulation without aids in pre-morbid condition\n* Multi-ligament knee injury with or without associated peri-articular fracture\n* Operative management within three weeks of the injury\n\nExclusion Criteria:\n\n* Poly-trauma with life-threatening injuries preventing rehabilitation\n* Patients unable to comply with intensive rehabilitation\n* Patients unable or unlikely to maintain follow-up'}, 'identificationModule': {'nctId': 'NCT01296750', 'acronym': 'Co_Leap', 'briefTitle': 'Late Compared to Early Physiotherapy Following Knee Dislocation', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'A Randomized Clinical Trial Comparing Late Versus Early Physiotherapy Start Times Following Multi Ligament Reconstruction for Knee Dislocation (Co-LEAP)', 'orgStudyIdInfo': {'id': 'SMH Co_LEAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Early Physiotherapy', 'description': 'Physiotherapy to begin within 1 day post op.', 'interventionNames': ['Other: Early Physiotherapy start']}, {'type': 'NO_INTERVENTION', 'label': 'Late Physiotherapy', 'description': 'Physiotherapy to start 6 weeks post op'}], 'interventions': [{'name': 'Early Physiotherapy start', 'type': 'OTHER', 'description': 'Physiotherapy starting at one day post op', 'armGroupLabels': ['Early Physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}