Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-01-03 @ 11:05 PM
Study NCT ID:
NCT02450292
Status:
COMPLETED
Last Update Posted:
2022-11-16
First Post:
2015-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective CT Imaging of BioComposite Interference Screw With BTB
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-11', 'studyFirstSubmitDate': '2015-05-18', 'studyFirstSubmitQcDate': '2015-05-18', 'lastUpdatePostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Screw resorption', 'timeFrame': '5 years', 'description': 'Evaluated on X-ray and CT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ACL Tear']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the long-term appearance and resorption rate of biocomposite screws used during ACL reconstruction on X-ray and computed tomography (CT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults aged 18+ who had an anterior cruciate ligament (ACL) reconstruction about 5 years ago performed by one of the study investigators.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18-50\n* Patients who underwent primary ACL reconstruction performed by one of the study investigators at least 5 years ago\n* Isolated ACL tear\n* Type of graft used was bone-patellar tendon-bone autograft\n* Type of screw used to attach graft to the tibia and/or femur was a BioComposite interference screws (Arthrex, Inc.)\n* No degenerative joint disease on preoperative X-rays (\\> 50% joint space loss, presence of osteophytes)\n\nExclusion Criteria:\n\n* Revision ACL reconstructions\n* Types of grafts other than bone-patellar tendon-bone autograft were used\n* ACL tear with concomitant pathology\n* Degenerative joint disease on preoperative X-ray (\\> 50% joint space loss, presence of osteophytes)\n* Metal or other types of bioabsorbable screws other than BioComposite interference screws (Arthrex, Inc.) were used\n* ACL reconstruction performed less than 5 years ago\n* Pregnancy\n* Greater than Grade 2 laxity of other ligaments\n* No additional fixation'}, 'identificationModule': {'nctId': 'NCT02450292', 'briefTitle': 'Retrospective CT Imaging of BioComposite Interference Screw With BTB', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Retrospective CT Imaging of BioComposite Interference Screw in Patients Undergoing Anterior Cruciate Ligament Reconstruction With Bone-Patellar Tendon-Bone Graft', 'orgStudyIdInfo': {'id': '758594-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bioabsorbable screw fixation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Marc Fineberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Buffalo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Sports Medicine, Associate Professor of Clinical Orthopaedics', 'investigatorFullName': 'Marc Fineberg', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}