Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-26 @ 10:49 AM
Study NCT ID:
NCT01719666
Status:
COMPLETED
Last Update Posted:
2025-09-18
First Post:
2011-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medial Patellofemoral Ligament Reconstruction With or Without Lateral Retinaculum Release
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092462', 'term': 'Patella Fracture'}, {'id': 'D004204', 'term': 'Joint Dislocations'}], 'ancestors': [{'id': 'D000092443', 'term': 'Knee Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2011-12-22', 'studyFirstSubmitQcDate': '2012-10-30', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patellar tilt measurement', 'timeFrame': '2 years of follow up', 'description': 'IKDC score, patellar tilt measurement on x-rays and CT-scan'}], 'secondaryOutcomes': [{'measure': 'rate of complications', 'timeFrame': '2 years of follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MPFL', 'patella', 'dislocation', 'release'], 'conditions': ['Episodic Patellar Dislocation']}, 'referencesModule': {'references': [{'pmid': '40934533', 'type': 'RESULT', 'citation': 'Faure F, Erard J, Batailler C, Magnussen RA, Lustig S, Servien E. Lateral Retinacular Release During MPFL Reconstruction: A Randomized Clinical Trial. Am J Sports Med. 2025 Oct;53(12):2869-2874. doi: 10.1177/03635465251366306. Epub 2025 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesis is lateral retinaculum release has no effect on treatment of Patellar Recurrent Dislocation with Medial Patellofemoral Ligament (MPFL) reconstruction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18yo and 45yo\n* indication for MPFL reconstruction\n* unilateral or bilateral indication\n\nExclusion Criteria:\n\n* indication for bony procedures\n* previous surgery for PF disorders\n* patient refusal'}, 'identificationModule': {'nctId': 'NCT01719666', 'briefTitle': 'Medial Patellofemoral Ligament Reconstruction With or Without Lateral Retinaculum Release', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Randomized Control Trial on Lateral Retinaculum Release in MPFL Reconstruction', 'orgStudyIdInfo': {'id': '2010.651'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'isolated MPFL reconstruction', 'interventionNames': ['Procedure: conventional surgery']}, {'type': 'EXPERIMENTAL', 'label': 'MPFL reconstruction and Lateral retinaculum release', 'interventionNames': ['Procedure: MPFL reconstruction and lateral retinaculum release']}], 'interventions': [{'name': 'MPFL reconstruction and lateral retinaculum release', 'type': 'PROCEDURE', 'description': 'MPFL is performed with a standard technique using gracilis tendon. A tunnel is performed at the femoral part with a bioabsorbable screw fixation and 2 bundles with suture fixation at the patellar side', 'armGroupLabels': ['MPFL reconstruction and Lateral retinaculum release']}, {'name': 'conventional surgery', 'type': 'PROCEDURE', 'description': 'conventional surgery: MPFL reconstruction', 'armGroupLabels': ['isolated MPFL reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Croix-Rousse Hospital, Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}