Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-01 @ 10:18 AM
Study NCT ID:
NCT05904158
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2023-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Platelet-Rich Fibrin in Patients With Anterior Cruciate Ligament Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised controlled design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-06', 'studyFirstSubmitDate': '2023-05-27', 'studyFirstSubmitQcDate': '2023-06-06', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the Knee Laxity', 'timeFrame': 'Preoperatively ans one year postoperatively', 'description': 'Knee laxity was measured using Kneelax-3 Knee arthrometer'}], 'secondaryOutcomes': [{'measure': 'Changes in the Knee Muscle Strenght', 'timeFrame': 'Preoperatively ans one year postoperatively', 'description': 'Qudriceps and hamstring muscle strength were measured using an isokinetic dynamometer'}, {'measure': 'Changes in the Knee Function', 'timeFrame': 'Preoperatively and one year postoperatively', 'description': 'Knee function was assessed with one leg hop (OLH) test and Y-Balance tests'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anterior cruciate ligament', 'platelet-rich fibrin', 'return to play'], 'conditions': ['Effects of Platelet-Rich Fibrin on Knee Stability and Knee Function']}, 'descriptionModule': {'briefSummary': 'The study was conducted to investigate the effects of platelet-rich fibrin on knee stability, knee muscle strength and knee function in patients with ACL reconstruction. Thirty patients with ACL reconstruction were included to the study and randomly divided into two groups. Patients were assessed preoperative and at the postoperative 1-year.', 'detailedDescription': "The study was conducted yo investigate the effects of platelet-rich fibrin (PRF) on the knee stability and function in patients with anterior cruciate ligament (ACL) reconstruction. Thirty patients with ACL reconstruction were included to the study and randomly divided into two groups (PRF group and control group). Hamstring tendon autograft was used in all patients for the reconstruction of the teared ACL. A standardized postoperative rehabilitation program was applied to all patients. Patients' knee stability, knee muscle strength and knee function were assessed preoperatively and one-year postoperatively. Knee stability was assessed using KT-2000 Knee Arthrometer. Quadriceps femoris and hamstring muscle strength measurements were conducted with an isokinetic dynamometer at 60˚/sec and 180˚/sec angular velocities. One Leg Hop (OLH) and Y-Balance tests, and International Knee Documentation Committee (IKDC) were used to evaluate the knee function."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being isolated ACL reconstruction,\n* Being between the ages of 18-45 years,\n* Performing sports recreationally or professionally\n\nExclusion Criteria:\n\n* Having previous knee surgery,\n* Having systematic disease,\n* Having multiple ligament injury on the knee or additional cartilage injuries'}, 'identificationModule': {'nctId': 'NCT05904158', 'briefTitle': 'Effects of Platelet-Rich Fibrin in Patients With Anterior Cruciate Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Effects of Platelet-Rich Fibrin on Knee Muscle Strength and Function in Patients With Anterior Cruciate Ligament Reconstruction', 'orgStudyIdInfo': {'id': 'E-18-2060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRF Group', 'description': 'Patients in this group, received PRF application during the standard ACL reconstruction surgery', 'interventionNames': ['Biological: Platelet-Rich Fibrin during Standard ACL reconstruction surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Patients in this group received a standard ACL reconstruction surgery without any other intervention.', 'interventionNames': ['Other: Standard ACL reconstruction surgery']}], 'interventions': [{'name': 'Platelet-Rich Fibrin during Standard ACL reconstruction surgery', 'type': 'BIOLOGICAL', 'description': 'Plateleth-rich fibrin was obtained from patients own blood (40 cc) and applied to the tunnels which were drilled for ACL graft', 'armGroupLabels': ['PRF Group']}, {'name': 'Standard ACL reconstruction surgery', 'type': 'OTHER', 'description': 'This was a control group where patients received Standard ACL reconstruction surgery', 'armGroupLabels': ['Control Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Fzt. Serdar Demirci (Director of the study)', 'investigatorFullName': 'SERDAR DEMIRCI', 'investigatorAffiliation': 'Hacettepe University'}}}}