Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-25 @ 12:55 AM
Study NCT ID:
NCT04901559
Status:
COMPLETED
Last Update Posted:
2021-05-25
First Post:
2021-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subjective Outcomes After ACL Reconstruction With BQT Autograft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}, {'id': 'D007718', 'term': 'Knee Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-20', 'studyFirstSubmitDate': '2021-05-12', 'studyFirstSubmitQcDate': '2021-05-20', 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Knee Injury and Osteoarthritis Outcome Score from preoperative baseline to one-year follow-up', 'timeFrame': '1 year', 'description': 'BQT compared to STG and BPTB, respectively'}], 'secondaryOutcomes': [{'measure': 'Change in Knee Injury and Osteoarthritis Outcome Score subscale Pain from preoperative baseline to one-year follow-up', 'timeFrame': '1 year', 'description': 'BQT compared to STG and BPTB, respectively'}, {'measure': 'Change in Knee Injury and Osteoarthritis Outcome Score subscale Symptoms from preoperative baseline to one-year follow-up', 'timeFrame': '1 year', 'description': 'BQT compared to STG and BPTB, respectively'}, {'measure': 'Change in Knee Injury and Osteoarthritis Outcome Score subscale Activities of Daily Living (ADL) from preoperative baseline to one-year follow-up', 'timeFrame': '1 year', 'description': 'BQT compared to STG and BPTB, respectively'}, {'measure': 'Change in Knee Injury and Osteoarthritis Outcome Score subscale Sports/Recreation from preoperative baseline to one-year follow-up', 'timeFrame': '1 year', 'description': 'BQT compared to STG and BPTB, respectively'}, {'measure': 'Change in Knee Injury and Osteoarthritis Outcome Score subscale Quality of Life (QoL) from preoperative baseline to one-year follow-up', 'timeFrame': '1 year', 'description': 'BQT compared to STG and BPTB, respectively'}, {'measure': 'Change in Tegner activity score from preoperative baseline to one-year follow-up', 'timeFrame': '1 year', 'description': 'BQT compared to STG and BPTB, respectively'}, {'measure': 'Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Pain at one-year follow-up', 'timeFrame': '1 year', 'description': 'BQT compared to STG and BPTB, respectively'}, {'measure': 'Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Symptoms at one-year follow-up', 'timeFrame': '1 year', 'description': 'BQT compared to STG and BPTB, respectively'}, {'measure': 'Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Activities of Daily Living (ADL) at one-year follow-up', 'timeFrame': '1 year', 'description': 'BQT compared to STG and BPTB, respectively'}, {'measure': 'Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Sports/Recreation at one-year follow-up', 'timeFrame': '1 year', 'description': 'BQT compared to STG and BPTB, respectively'}, {'measure': 'Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Quality of Life (QoL) at one-year follow-up', 'timeFrame': '1 year', 'description': 'BQT compared to STG and BPTB, respectively'}, {'measure': 'Absolute results of Tegner activity score at one-year follow-up', 'timeFrame': '1 year', 'description': 'BQT compared to STG and BPTB, respectively'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ACL Injury', 'Knee Injuries']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare short-term patient reported outcome measures (PROM) of Bone-Quadriceps-Tendon (BQT) autograft with Semitendinosus-Gracilis (STG) and Bone-Patellar-Tendon-Bone (BPTB) autografts following Anterior Cruciate Ligament Reconstruction (ACLR).\n\nThe PROM used are Knee Injury and Osteoarthrithis Outcome Score (KOOS) and Tegner. Difference in change in KOOS, KOOS subscales and Tegner from preoperative baseline to one-year follow-up and absolute KOOS, KOOS subscales and Tegner at one-year follow-up were evaluated. All of which were BQT compared to STG and BPTB, respectively. The primary outcome is change in KOOS from preoperative baselinge to one-year follow-up. Other outcomes are secondary.\n\nThe hypothesis was that patients receiving the BQT autograft show similar results in KOOS, KOOS subscales and Tegner as patients receiving STG or BPTB autografts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from the nationwide Danish Knee Ligament Reconstruction Register (DKLR) recruited from both private and public clinics from January 1st 2005 through December 31st 2018.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* Revision ACL Surgery\n* Multiligament surgery\n* Nonresponders in PROM at preoperative baseline or one-year follow-up'}, 'identificationModule': {'nctId': 'NCT04901559', 'briefTitle': 'Subjective Outcomes After ACL Reconstruction With BQT Autograft', 'organization': {'class': 'OTHER', 'fullName': 'Region Zealand'}, 'officialTitle': 'Subjective Outcomes After ACL Reconstruction With BQT Autograft', 'orgStudyIdInfo': {'id': 'BQT-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BQT', 'description': 'Patients treated with the Bone Quadriceps Tendon (BQT) autograft', 'interventionNames': ['Procedure: Graft type at ACLR']}, {'label': 'STG', 'description': 'Patients treated with the Semitendinosus-Gracilis (STG) autograft', 'interventionNames': ['Procedure: Graft type at ACLR']}, {'label': 'BPTB', 'description': 'Patients treated with the Bone-Patellar Tendon-Bone (BPTB) autograft', 'interventionNames': ['Procedure: Graft type at ACLR']}], 'interventions': [{'name': 'Graft type at ACLR', 'type': 'PROCEDURE', 'description': 'The choice of graft at primary ACL Reconstruction', 'armGroupLabels': ['BPTB', 'BQT', 'STG']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Zealand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical student', 'investigatorFullName': 'Jesper Glerup', 'investigatorAffiliation': 'Region Zealand'}}}}