Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
Study NCT ID:
NCT04135950
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2019-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Registry of Anterior Cruciate Ligament Reconstructions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1646}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2019-10-21', 'studyFirstSubmitQcDate': '2019-10-21', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'additional injury', 'timeFrame': 'intraoperatively', 'description': 'At the time of ACL surgery, it is determined if the patient has any other injuries to the meniscus or cartilage.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Tear', 'Meniscal Tear', 'Cartilage Injury', 'Bone Bruising']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate factors that are associated with outcomes of injury to the anterior cruciate ligament (ACL) in the knee among patients who are undergoing surgical reconstruction. This study is a registry of all patients having knee surgery at our institution performed by 4 fellowship-trained orthopaedic surgeons. The surgeon documents patient information on standard data forms including risk factors and surgical findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients at our institution who are having ACL surgery by one of 4 fellowship-trained surgeons will be included in this registry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing ACL surgery\n\nExclusion Criteria:\n\n* Previous surgery on the affected knee\n* Posterior cruciate ligament injuries\n* Grade 2 lateral collateral ligament or medial collateral ligament injuries'}, 'identificationModule': {'nctId': 'NCT04135950', 'briefTitle': 'Prospective Registry of Anterior Cruciate Ligament Reconstructions', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Prospective Registry of Predictors and Comorbid Injuries Associated With Anterior Cruciate Ligament Reconstructions', 'orgStudyIdInfo': {'id': '441874-2'}}, 'contactsLocationsModule': {'locations': [{'zip': '14226', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'UBMD Orthopaedics and Sports Medicine', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'June A. and Eugene R. Mindell, MD Professor and Chair', 'investigatorFullName': 'Leslie Bisson', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}