Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-02-07 @ 6:44 AM
Study NCT ID:
NCT02542566
Status:
TERMINATED
Last Update Posted:
2017-04-06
First Post:
2015-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protected Versus Early Weight Bearing Post Microfracture Surgery
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': 6}}, 'statusModule': {'whyStopped': 'Study was stopped prematurely due to the lack of eligible participants.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-04', 'studyFirstSubmitDate': '2015-09-03', 'studyFirstSubmitQcDate': '2015-09-03', 'lastUpdatePostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Tegner/Lysholm score from questionnaires.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Time to return to work.', 'timeFrame': '12 months'}, {'measure': 'Time to return to sporting activities', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Defect of Articular Cartilage']}, 'descriptionModule': {'briefSummary': 'To test using a randomised control trial, whether conservative rehabilitation and protected weight bearing versus early weight bearing and accelerated rehabilitation affects patient outcomes post microfracture surgery of the knee.', 'detailedDescription': 'To test using a randomised control trial, whether conservative rehabilitation and protected weight bearing versus early weight bearing and accelerated rehabilitation affects patient outcomes post microfracture surgery of the knee.\n\nCurrent practice in most units is to protect patients from weight bearing prior to entering a conservative physiotherapy rehabilitation program following microfracture surgery of the knee. At our unit we believe that protecting patients from weight bearing post microfracture surgery makes no difference to their outcome and only leads to a longer rehabilitation time and a delayed return to work and sports. Therefore we want to randomise patients who require microfracture surgery of the knee for cartilage defects into 2 post operative rehabilitation groups. One group will be able to weight bear early and will undergo an accelerated rehabilitation program whilst the other will be protected from weight bearing and will undergo a more conservative rehabilitation program. We will then follow patients up over a year and compare outcome data collected at 6 weeks, 3 months, 6 months and 1 year post operatively to see if there was any difference in outcomes between the 2 groups. As secondary outcomes we will also compare the patients in the two groups to see if there is a difference in time taken to return to work and sporting activities'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 16-60 years. Mechanically stable knee joint at outpatient examination. MRI confirmed grade 3 or 4 non-kissing cartilage defect within the knee. Able to fully understand the process and study and give informed consent to participate.\n\nAble to comply with the physiotherapy rehabilitation and follow up process.\n\nExclusion Criteria:\n\n* Kissing cartilage defects. Defects deemed too large to undergo microfracture on MRI scan. Clinically unstable knee joint. Patients unable to consent to participation. Under 16 years of age or over 60 years of age. Patients likely to drop out of physiotherapy rehabilitation and study follow up.'}, 'identificationModule': {'nctId': 'NCT02542566', 'briefTitle': 'Protected Versus Early Weight Bearing Post Microfracture Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust'}, 'officialTitle': 'Randomised Control Trial Comparing Conservative Rehabilitation and Protected Weight Bearing Versus Accelerated Rehabilitation and Early Weight Bearing Post Microfracture Knee Surgery.', 'orgStudyIdInfo': {'id': 'version 4 28/08/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'early weight bearing', 'description': 'early weight bearing and accelerated physiotherapy rehabilitation', 'interventionNames': ['Procedure: Physiotherapy rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'protected weight bearing', 'description': 'protected weight bearing and conservative physiotherapy rehabilitation.', 'interventionNames': ['Procedure: Physiotherapy rehabilitation']}], 'interventions': [{'name': 'Physiotherapy rehabilitation', 'type': 'PROCEDURE', 'description': 'Physiotherapy rehabilitation', 'armGroupLabels': ['early weight bearing', 'protected weight bearing']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SY10 7AG', 'city': 'Oswestry', 'state': 'Shropshire', 'country': 'United Kingdom', 'facility': 'The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS FT', 'geoPoint': {'lat': 52.86195, 'lon': -3.05497}}], 'overallOfficials': [{'name': 'Peter Gallacher, Surgeon', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NHS Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}