Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-03 @ 5:31 PM
Study NCT ID:
NCT06541756
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2024-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fibrine Clot-augmented Repair of Longitudinal Meniscus Tears
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007718', 'term': 'Knee Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'not possible'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective Randomized Controlled Study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2024-08-01', 'studyFirstSubmitQcDate': '2024-08-06', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with a healed meniscus on MRI', 'timeFrame': 'Postoperative 1st year', 'description': 'Meniscal healing at 1 year follow up as detected on the control MRI (yes / no / partial)'}], 'secondaryOutcomes': [{'measure': 'Tegner Activity Scale', 'timeFrame': 'Postoperative 1.st year', 'description': 'minimum value:0, maximum value 10, higher values mean better outcome'}, {'measure': 'The Knee injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': 'Postoperative 1.st year', 'description': 'minimum value:0, maximum value 100, higher values mean better outcome'}, {'measure': 'Tegner-Lysholm Score', 'timeFrame': 'Postoperative 1.st year', 'description': 'minimum value:0, maximum value 100, higher values mean better outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meniscus Tear', 'Meniscus Lesion', 'Fibrin Blood Clot', 'Knee Injuries']}, 'referencesModule': {'references': [{'pmid': '35258647', 'type': 'BACKGROUND', 'citation': "Keller RE, O'Donnell EA, Medina GIS, Linderman SE, Cheng TTW, Sabbag OD, Oh LS. Biological augmentation of meniscal repair: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2022 Jun;30(6):1915-1926. doi: 10.1007/s00167-021-06849-5. Epub 2022 Mar 8."}, {'pmid': '38288322', 'type': 'BACKGROUND', 'citation': 'Chrysanthou C, Laliotis N, Paraskevas GK, Anastasopoulos N, Packer G. Enhancing Meniscal Repair: Investigating the Impact of an Exogenous Fibrin Clot. Cureus. 2024 Jan 27;16(1):e53083. doi: 10.7759/cureus.53083. eCollection 2024 Jan.'}, {'pmid': '36632380', 'type': 'BACKGROUND', 'citation': 'Rodriguez AN, Reist H, Liechti DJ, Geeslin AG, LaPrade RF. Shuttling Technique for Directed Fibrin Clot Placement During Augmented Inside-Out Repair of Horizontal Meniscus Tears. Arthrosc Tech. 2022 Nov 17;11(12):e2205-e2211. doi: 10.1016/j.eats.2022.08.027. eCollection 2022 Dec.'}, {'pmid': '36574822', 'type': 'BACKGROUND', 'citation': 'Kinoshita T, Hashimoto Y, Orita K, Iida K, Takahashi S, Nakamura H. Bone Marrow-Derived Fibrin Clots Stimulate Healing of a Knee Meniscal Defect in a Rabbit Model. Arthroscopy. 2023 Jul;39(7):1662-1670. doi: 10.1016/j.arthro.2022.12.013. Epub 2022 Dec 24.'}, {'pmid': '36035781', 'type': 'BACKGROUND', 'citation': 'Kale S, Deore S, Gunjotikar A, Singh S, Ghodke R, Agrawal P. Arthroscopic meniscus repair and augmentation with autologous fibrin clot in Indian population: A 2-year prospective study. J Clin Orthop Trauma. 2022 Aug 6;32:101969. doi: 10.1016/j.jcot.2022.101969. eCollection 2022 Sep.'}]}, 'descriptionModule': {'briefSummary': 'Longitudinal meniscal tears are a type of meniscal injury characterized by a displaced fragment of the meniscus that flips over into the joint, often resembling a buckle or handle. These tears typically occur in the medial meniscus and are often associated with traumatic knee injuries, particularly in athletes.\n\nThe displaced meniscal fragment can cause mechanical symptoms such as locking, clicking, or catching of the knee, as well as pain and swelling. If not properly treated, buckle-handle meniscal tears can lead to further complications, including chronic knee instability, increased risk of osteoarthritis, and persistent joint pain.Repairing a longitudinal meniscal tear offers several advantages over partial meniscectomy, particularly in preserving knee function and preventing long-term complications.\n\nMeniscal repair aims to restore the integrity of the meniscus, which plays a crucial role in load distribution, shock absorption, and joint stability.\n\nUtilizing a fibrin clot during the repair of a buckle-handle meniscal tear can enhance the healing process and improve surgical outcomes. Fibrin clots act as a biological scaffold, promoting tissue regeneration by providing a matrix that facilitates cellular migration and proliferation.\n\nThe purpose of this study was to compare longitudinal meniscal tear repair reinforced with fibrin clot with routine end-to-end repair in a prospective randomized controlled trial.', 'detailedDescription': 'This study is designed as a prospective randomized controlled clinical trial. It aims to include patients presenting to the Orthopedics and Traumatology clinics at Ankara Bilkent and Etlik City Hospitals with longitudinal meniscus tears between August 2024 and December 2028. Participants will be randomly assigned to one of two groups: one receiving meniscus repair with fibrin clot reinforcement and the other receiving standard repair.\n\nPatients in the standard repair group will undergo routine meniscus repair surgery using arthroscopic all-inside or inside-out sutures, with spinal anesthesia. For the fibrin clot group, a fibrin clot will be prepared from 50cc of bone marrow aspirate obtained from the iliac crest and mixed for 15 minutes. The fibrin clot will be shaped into a cylindrical form and compressed between the torn edges of the meniscus using a trocar system, then secured with sutures. After completing the repairs, the surgical wounds and portals will be closed, and an elastic bandage will be applied. The post-operative rehabilitation protocols will be the same for all patients.\n\nPatients will be clinically followed for at least one year, with healing rates compared using control magnetic resonance imaging at the end of the first year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presenting with a painful meniscus (lateral or medial) longitudinal tear\n* Being between the ages of 18 and 50\n* Not having undergone surgery on the same knee before\n* Having an MRI taken at the end of the 1st year post-surgery\n\nExclusion Criteria:\n\n* Having additional collateral ligamentous damage along with the meniscus tear (such as MCL or LCL)\n* Incomplete clinical scores at the end of the study\n* A history of previous surgery on the same knee\n* Having an active infection\n* Not having a control MRI at the end of the 1st year'}, 'identificationModule': {'nctId': 'NCT06541756', 'acronym': 'FCAR', 'briefTitle': 'Fibrine Clot-augmented Repair of Longitudinal Meniscus Tears', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Fibrine Clot-augmented Repair of Longitudinal Meniscus Tears - A Prospectively Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'E2-24-7900'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fibrin Clot-augmented group', 'description': 'Patients in the experimental repair group will undergo routine meniscus repair surgery in addition to a fibrin clot placed within the ruptured sides using arthroscopic all-inside or inside-out sutures. The fibrin clot will be prepared from 50cc of bone marrow aspirate obtained from the iliac crest and mixed for 15 minutes. The clot will be shaped into a cylindrical form and compressed between the torn edges of the meniscus using a trocar system, then secured with sutures.', 'interventionNames': ['Procedure: Fibrine Clot-augmented Meniscal Repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventionally repaired group', 'description': 'Patients in the control repair group will undergo routine meniscus repair surgery using arthroscopic all-inside or inside-out sutures. The ruptured sides will be approximated as usual and the procedure will be considered completed.', 'interventionNames': ['Procedure: Conventional Meniscal Repair']}], 'interventions': [{'name': 'Fibrine Clot-augmented Meniscal Repair', 'type': 'PROCEDURE', 'description': 'The fibrin clot will be prepared from 50cc of bone marrow aspirate obtained from the iliac crest and mixed for 15 minutes. The fibrin clot will be shaped into a cylindrical form and compressed between the torn edges of the meniscus using a trocar system, then secured with sutures.', 'armGroupLabels': ['Fibrin Clot-augmented group']}, {'name': 'Conventional Meniscal Repair', 'type': 'PROCEDURE', 'description': 'Patients in the standard repair group will undergo routine meniscus repair surgery using arthroscopic all-inside or inside-out sutures.', 'armGroupLabels': ['Conventionally repaired group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Enejd Veizi, MD', 'role': 'CONTACT', 'email': 'dr.nad89@hotmail.com', 'phone': '+905439799959'}], 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06000', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Yasin Erdoğan, MD', 'role': 'CONTACT', 'email': 'yasin-erdgn@hotmail.com', 'phone': '+905056056097'}], 'facility': 'Ankara Etlik City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Enejd Veizi, MD', 'role': 'CONTACT', 'email': 'dr.nad89@hotmail.com', 'phone': '+905439799959'}, {'name': 'Yasin Erdoğan, MD', 'role': 'CONTACT', 'email': 'yasin-erdgn@hotmail.com', 'phone': '+905056056097'}], 'overallOfficials': [{'name': 'Enejd Veizi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara City Hospital Bilkent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ankara Etlik City Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Enejd Veizi, MD', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}