Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT04950335
Status:
COMPLETED
Last Update Posted:
2021-07-06
First Post:
2021-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of AOCT and AOPT for the Treatment of Medial Large Cystic OLT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-01', 'studyFirstSubmitDate': '2021-06-25', 'studyFirstSubmitQcDate': '2021-07-01', 'lastUpdatePostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MOCART', 'timeFrame': 'two years after sugery', 'description': 'the Magnetic Resonance Observation of Cartilage Repair Tissue score'}], 'secondaryOutcomes': [{'measure': 'VAS', 'timeFrame': 'pre-surgery, two years after sugery', 'description': 'the visual analog scale'}, {'measure': 'Tegner', 'timeFrame': 'pre-surgery, two years after sugery', 'description': 'the Tegner score'}, {'measure': 'AOFAS', 'timeFrame': 'pre-surgery, two years after sugery', 'description': 'American Orthopaedic Foot \\& Ankle Society score'}, {'measure': 'ICRS', 'timeFrame': 'one year after sugery', 'description': 'the International Cartilage Repair Society score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteochondral Lesions of the Talus']}, 'descriptionModule': {'briefSummary': 'Autologous osteoperiosteal transplantation using tissue harvested from the iliac crest is used to treat large cystic osteochondral lesions of the talus. This study is to compare clinical and radiological outcomes between patients undergoing AOPT and those undergoing AOCT for large cystic OLTs.', 'detailedDescription': 'From March 2015 to March 2018, 23 patients who underwent AOPT and 23 patients who underwent AOCT to treat large cystic OLTs (\\>10mm) were retrospectively evaluated. For comparability, the two groups were matched based on their demographics, including sex, age, body mass index, side of injury, follow-up period, and the preoperative cyst volume. Clinical outcomes were assessed using the visual analog scale (VAS), the American Orthopaedic Foot \\& Ankle Society (AOFAS) score, and the Tegner score. Donor-site morbidity was recorded according to the symptoms, including pain, stiffness, swelling and discomfort. Radiological outcomes were evaluated using the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, and the International Cartilage Repair Society (ICRS) score was obtained during second-look surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with symptomatic OLTs who underwent AOPT or AOCTvat our sports medicine institute between March, 2015 and March, 2018', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presence of medial large cystic OLTs (\\>10 mm in diameter) confirmed by preoperative magnetic resonance imaging (MRI)\n* patients who underwent either primary AOPT or AOCT\n\nExclusion Criteria:\n\n* small cystic OLTs\n* ankle osteoarthritis\n* ankle pigmented villonodular synovitis\n* prior surgery on the ipsilateral ankle\n* injuries or relevant trauma to the affected ankle after surgery'}, 'identificationModule': {'nctId': 'NCT04950335', 'briefTitle': 'Comparison of AOCT and AOPT for the Treatment of Medial Large Cystic OLT', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Comparison of Autologous Osteoperiosteal and Osteochondral Transplantation for the Treatment of Medial Large Cystic Osteochondral Lesions of the Talus', 'orgStudyIdInfo': {'id': 'M2021055'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AOPT', 'description': 'patients underwent AOPT to treat large cystic OLTs (\\>10mm)', 'interventionNames': ['Procedure: AOPT']}, {'label': 'AOCT', 'description': 'patients underwent AOCT to treat large cystic OLTs (\\>10mm)', 'interventionNames': ['Procedure: AOCT']}], 'interventions': [{'name': 'AOPT', 'type': 'PROCEDURE', 'description': 'The Osteochondral Autograft Transplant System (Arthrex) was used to create donor plugs. Osteoperiosteal grafts were harvested from the ipsilateral anterior superior iliac spine.', 'armGroupLabels': ['AOPT']}, {'name': 'AOCT', 'type': 'PROCEDURE', 'description': 'Osteochondral grafts were harvested from the non-weight-bearing zone of the ipsilateral anterolateral distal femur.', 'armGroupLabels': ['AOCT']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Qinwei Guo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}