Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
Study NCT ID:
NCT06617559
Status:
RECRUITING
Last Update Posted:
2024-09-27
First Post:
2024-09-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Autologous Quadriceps and Hamstring Tendon Grafts in Anterior Cruciate Ligament Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}, {'id': 'D001265', 'term': 'Athletic Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059549', 'term': 'Anterior Cruciate Ligament Reconstruction'}], 'ancestors': [{'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are two standard autografts used for ACL reconstruction in the investigators\\' clinic: quadriceps and hamstring autografts. Patients will be randomly assigned to groups based on the order of their hospital admission. It is planned to have at least 25 patients in each group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-26', 'studyFirstSubmitDate': '2024-09-23', 'studyFirstSubmitQcDate': '2024-09-26', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Autograft Maturation', 'timeFrame': '12 months', 'description': 'Comparison of different autografts maturation on MRI images. The signal-to-noise quotient formula will be used to assess graft maturation. According to the method described by Chan and Yau, the difference between the signals of the ACL graft and the quadriceps tendon will be used to evaluate maturation by relating it to the background signal.'}, {'measure': 'Stability of Knee', 'timeFrame': '9 months', 'description': 'Pivot shift test'}, {'measure': 'Stability of Knee', 'timeFrame': '9 months', 'description': 'laxity measuring with KT-1000 device'}, {'measure': 'Stability of Knee', 'timeFrame': '9 months', 'description': 'Lachman test'}], 'secondaryOutcomes': [{'measure': 'Range of Motion', 'timeFrame': '6 months', 'description': 'Measurement of knee flexion and extension degrees with a goniometer.'}, {'measure': 'Muscle Strength', 'timeFrame': '9 months', 'description': 'Measurement of quadriceps and hamstring muscle strength with Cybex test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anterior cruciate ligament reconstruction', 'hamstring tendons', 'athletic injuries'], 'conditions': ['Anterior Cruciate Ligament Injuries', 'Athletic Injuries', 'Tendon Graft; Complications']}, 'referencesModule': {'references': [{'pmid': '30790526', 'type': 'BACKGROUND', 'citation': 'Mouarbes D, Menetrey J, Marot V, Courtot L, Berard E, Cavaignac E. Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis of Outcomes for Quadriceps Tendon Autograft Versus Bone-Patellar Tendon-Bone and Hamstring-Tendon Autografts. Am J Sports Med. 2019 Dec;47(14):3531-3540. doi: 10.1177/0363546518825340. Epub 2019 Feb 21.'}, {'pmid': '32345925', 'type': 'BACKGROUND', 'citation': 'Lin KM, Boyle C, Marom N, Marx RG. Graft Selection in Anterior Cruciate Ligament Reconstruction. Sports Med Arthrosc Rev. 2020 Jun;28(2):41-48. doi: 10.1097/JSA.0000000000000265.'}, {'pmid': '28273424', 'type': 'BACKGROUND', 'citation': 'Cavaignac E, Coulin B, Tscholl P, Nik Mohd Fatmy N, Duthon V, Menetrey J. Is Quadriceps Tendon Autograft a Better Choice Than Hamstring Autograft for Anterior Cruciate Ligament Reconstruction? A Comparative Study With a Mean Follow-up of 3.6 Years. Am J Sports Med. 2017 May;45(6):1326-1332. doi: 10.1177/0363546516688665. Epub 2017 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'With the recent technological advancements, the use of the quadriceps tendon with an all-inside technique has come to the forefront, and large-scale research has focused especially on quadriceps tendon grafts. Clinical study results have reported that the outcomes are similar to those of patellar tendon grafts and either equivalent or superior to hamstring tendon grafts.\n\nThe aim of this study is the prospective comparison of the clinical and radiological outcomes of patients who underwent anterior cruciate ligament (ACL) reconstruction with autologous hamstring and quadriceps tendon grafts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elite athletes\n* Amateur athletes\n* Anterior cruciate ligament injury\n\nExclusion Criteria:\n\n* Revision surgery\n* Another ligament injury ( medial collateral ligament, lateral collateral ligament, etc.. )\n* \\> Grade-2 cartilage injury\n* Having previously undergone surgery on the same knee\n* \\< 18 years age'}, 'identificationModule': {'nctId': 'NCT06617559', 'briefTitle': 'Comparison of Autologous Quadriceps and Hamstring Tendon Grafts in Anterior Cruciate Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'A Prospective Comparison of Clinical and Radiological Maturation Outcomes of Autologous Quadriceps and Hamstring Tendon Grafts in Anterior Cruciate Ligament Reconstruction', 'orgStudyIdInfo': {'id': 'Fulyamaslak'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All-inside Quadriceps Tendon Graft Group', 'interventionNames': ['Procedure: Anterior Cruciate Ligament Reconstruction with Quadriceps Autograft']}, {'type': 'EXPERIMENTAL', 'label': 'All-inside Hamstring Tendon Graft Group', 'interventionNames': ['Procedure: Anterior Cruciate Ligament Reconstruction with Hamstring Autograft']}], 'interventions': [{'name': 'Anterior Cruciate Ligament Reconstruction with Quadriceps Autograft', 'type': 'PROCEDURE', 'description': 'The investigators will perform all-inside anterior cruciate ligament reconstruction using only the tendon portion of the quadriceps tendon (without bone fragments) in this group.', 'armGroupLabels': ['All-inside Quadriceps Tendon Graft Group']}, {'name': 'Anterior Cruciate Ligament Reconstruction with Hamstring Autograft', 'type': 'PROCEDURE', 'description': 'The investigators will perform all-inside anterior cruciate ligament reconstruction using the hamstring tendon as a graft in this group.', 'armGroupLabels': ['All-inside Hamstring Tendon Graft Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34394', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Muzaffer Agir', 'role': 'CONTACT', 'email': 'muzafferagir@gmail.com', 'phone': '+905543060011'}], 'facility': 'Acibadem Fulya Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Muzaffer Agir, MD', 'role': 'CONTACT', 'email': 'muzafferagir@gmail.com', 'phone': '+905543060011'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The investigators do not plan to share de-identified individual participant data (IPD).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muzaffer Agir', 'class': 'OTHER'}, 'collaborators': [{'name': 'Acibadem University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Muzaffer Agir', 'investigatorAffiliation': 'Acibadem University'}}}}