Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-30 @ 7:45 PM
Study NCT ID:
NCT01693757
Status:
COMPLETED
Last Update Posted:
2012-09-26
First Post:
2012-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Outcome Anterior Cruciate Ligament Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-24', 'studyFirstSubmitDate': '2012-05-25', 'studyFirstSubmitQcDate': '2012-09-24', 'lastUpdatePostDateStruct': {'date': '2012-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hop values for the both legs in Single, 6-m, Cross-over and Triple hops', 'timeFrame': 'Patients were followed up to 8 months post-surgery'}], 'secondaryOutcomes': [{'measure': 'Landing and Take-off Ground Reaction Forces', 'timeFrame': 'Patients were followed up to 8 months post-surgery'}, {'measure': 'Strength of Quadriceps and Hamstrings', 'timeFrame': 'Patients were followed up to 8 months post-surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anterior Cruciate Ligament', 'Hamstrings versus patellar tendon', 'Hop test', 'Return to sports'], 'conditions': ['Complications of Surgical Procedures or Medical Care']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare hop performance and jump landing strategy in soccer players with higher level sports activities after ACLR using either BPTB or STG and controls.', 'detailedDescription': 'The choice of graft for anterior cruciate ligament reconstruction (ACLR) remains controversial. Despite the need for outcome studies comparing bone-patellar tendon-bone (BPTB) with semitendinosus and gracilis tendon (STG), few studies have evaluated functional outcomes. The objective of the current study was to compare hop performance and jump landing strategy in soccer players with higher level sports activities after ACLR using either BPTB or STG and controls.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients with ACL deficiency were invited to participate in a randomized trial comparing ACLR with either a BPTB or STG graft.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ACLR and controls.\n\nExclusion Criteria:\n\n* Musculoskeletal injuries'}, 'identificationModule': {'nctId': 'NCT01693757', 'briefTitle': 'Functional Outcome Anterior Cruciate Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'University of Social Welfare and Rehabilitation Science'}, 'officialTitle': 'Comparison of Functional Outcome Measures of Anterior Cruciate Ligament Reconstruction Using Either Patellar Tendon or Hamstring Tendon Grafts and Controls in Competitive Soccer Players: A Randomized Trial', 'orgStudyIdInfo': {'id': '3'}, 'secondaryIdInfos': [{'id': 'USWR', 'type': 'OTHER', 'domain': 'USWR'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'BPTB group', 'description': 'Bone-patellar tendon-bone'}, {'label': 'STG group', 'description': 'Semitendinosus and gracilis tendon'}, {'label': 'Control', 'description': 'Healthy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'USWR', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Mahyar Salavati, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'USWR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Social Welfare and Rehabilitation Science', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Farshid Mohammadi', 'investigatorAffiliation': 'University of Social Welfare and Rehabilitation Science'}}}}