Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT04940169
Status:
COMPLETED
Last Update Posted:
2021-06-25
First Post:
2021-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anterior Cruciate Ligament Reconstruction Made With Hamstring Tendon And Quadriceps Tendon Autografts
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-17', 'studyFirstSubmitDate': '2021-06-11', 'studyFirstSubmitQcDate': '2021-06-17', 'lastUpdatePostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'KOOS', 'timeFrame': 'Change from Baseline score at one year.', 'description': 'Simple patient reported questionnaire'}, {'measure': 'lysholm', 'timeFrame': 'Change from Baseline score at one year.', 'description': 'Simple patient reported questionnaire'}, {'measure': 'VAS', 'timeFrame': 'Change from baseline score at one year.', 'description': 'Simple patient reported questionnaire'}, {'measure': 'IKDC', 'timeFrame': 'Change from baseline score at one year.', 'description': 'Simple patient reported questionnaire'}, {'measure': 'STRENGTH TEST', 'timeFrame': 'Change from baseline score at one year.', 'description': 'Simple patient reported questionnaire'}, {'measure': 'subjective instability test', 'timeFrame': 'Change from baseline score at one year.', 'description': 'instability measure with help of examinations'}, {'measure': 'thigh circumference', 'timeFrame': 'Change from baseline score at one year.', 'description': 'circumference measure'}, {'measure': 'one leg hop test', 'timeFrame': 'Change from baseline score at one year.', 'description': 'ask to participant hop on operated leg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Injuries']}, 'descriptionModule': {'briefSummary': 'Anterior cruciate ligament reconstruction (ACLR) is one of the most common procedure all around the world, however optimal graft source for ACLR still remains controversial. Although Quadriceps tendon (QT) is the least used and least studied autograft, it could be an appropriate and good alternative for ACLR. If investigaters use the same surgical technique, and exert the same rehabilitation methods they may have better results than hamstring tendon (HT) autografts.', 'detailedDescription': 'Investigators enrolled 36 patient and randomized them to different group (HT, QT). at the first evaluation examination findings noted, PROMs (patient reported outcome measurements) questioned, thigh circumference measured, flexor and extensor thigh muscle strength recorded with help of Humac CYBEX Norm (CSMI, 2004) device. After these examinations and preparations all patients operated by the same surgeon who is familiar with both technique. The same surgical technique and fixation method used for both groups. At 1st year follow-up all evaluations PROMs (İKDC,lysholm,VAS) and measurements repeated. Back to the sports rates and postoperative complications compared between HT-QT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ndiagnosed primary ACL rupture willing to involve study\n\n* lesser than Outerbridge 2 cartilage lesions, non-buckethandle meniscus injuries\n\nExclusion Criteria:\n\nmore than one ligament injury greater than outerbridge 3 cartilage injury buckethandle meniscus injuries re-ruptures bilateral injuries previous knee surgery any disease affecting muscle strength\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04940169', 'briefTitle': 'Anterior Cruciate Ligament Reconstruction Made With Hamstring Tendon And Quadriceps Tendon Autografts', 'organization': {'class': 'OTHER', 'fullName': 'SB Istanbul Education and Research Hospital'}, 'officialTitle': 'Prospective Comparison Of Arthroscopic Anterior Cruciate Ligament Reconstrictions Made With Hamstring Tendon And Quadriceps Tendon Autografts', 'orgStudyIdInfo': {'id': 'IER Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'quadriceps tendon autograft', 'description': 'Ramdomized half of the patient underwent quadriceps graft harvesting. Arthroscopic technique fixation methods rehabilitation style follow periods kept same as hamstring group except graft type.', 'interventionNames': ['Procedure: anterior cruciate ligament recontruction']}, {'type': 'EXPERIMENTAL', 'label': 'hamstring tendon autograft', 'description': 'Ramdomized half of the patient underwent hamstring graft harvesting. Arthroscopic technique fixation methods rehabilitation style follow periods kept same as hamstring group except graft type.', 'interventionNames': ['Procedure: anterior cruciate ligament recontruction']}], 'interventions': [{'name': 'anterior cruciate ligament recontruction', 'type': 'PROCEDURE', 'description': 'Firstly graft is harvested with help of arthroscopy femoral and tibial tunnels created then graft placed into tunnels', 'armGroupLabels': ['hamstring tendon autograft', 'quadriceps tendon autograft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34098', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul education and research hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SB Istanbul Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'attendant', 'investigatorFullName': 'Neset Tang', 'investigatorAffiliation': 'SB Istanbul Education and Research Hospital'}}}}