Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2026-01-07 @ 12:57 PM
Study NCT ID:
NCT04462458
Status:
RECRUITING
Last Update Posted:
2023-03-13
First Post:
2020-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
M-ARS ACL Post-marketing Surveillance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-10', 'studyFirstSubmitDate': '2020-07-02', 'studyFirstSubmitQcDate': '2020-07-02', 'lastUpdatePostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival rate', 'timeFrame': '6 months', 'description': 'Kaplan Meier method'}], 'secondaryOutcomes': [{'measure': 'Survival rate', 'timeFrame': '1, 12, 24 months', 'description': 'Kaplan Meier method'}, {'measure': 'Functional outcome', 'timeFrame': '1, 6, 12, 24 months', 'description': 'International Knee Documentation Committee (IKDC) score'}, {'measure': 'Quality of Life outcome', 'timeFrame': '1, 6, 12, 24 months', 'description': 'EQ-5D score'}, {'measure': 'Radiological outcome (optional)', 'timeFrame': '1, 6, 12, 24 months', 'description': 'Evaluation of ligament osteointegration, femoral/tibial tunnel widening, presence of fluid in the femoral/tibial tunnel'}, {'measure': 'Complication rate', 'timeFrame': 'intraoperative, 1, 6, 12, 24 months', 'description': 'Occurrence of intraoperative and postoperative complications'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament (ACL) Reconstruction']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the performance of Medacta Anatomic Ribbon Surgery (M-ARS) in patients requiring anterior cruciate ligament (ACL) reconstruction.\n\nThe main goal is to evaluate the survival rate of M-ARS ACL at 6 months post-operatively. The secondary goals are to assess the survival rate, clinical and functional outcomes, the quality of life, and the rate of complications at 1 month, 1 year and 2 years post-operatively.', 'detailedDescription': 'This s a prospective, multicenter, non-controlled, observational study to evaluate the outcomes of Medacta Anatomic Ribbon Surgery (M-ARS) in the reconstruction of the anterior cruciate ligament (ACL).\n\nParticipants will be informed about the study, both orally and in writing, during a preoperative visit. The investigator will answer any questions that may arise and will collect the informed consent. During the study, enrolled participants will be able to withdraw at any time and for any reason.\n\nThe study is conducted according to the following schedule:\n\n* V1 : Inclusion during a preoperative visit\n* V2: Surgery\n* V3: Follow-up visit at 1 month ± 15 days post-surgery\n* V4: Follow-up visit at 6 months ± 30 days post-surgery\n* V5: Follow-up visit at 12 months ± 60 days post-surgery\n* V6: Follow-up visit at 24 months ± 90 days post-surgery\n\nThe following data will be collected:\n\n* Survival rate of implants evaluating the incidence of implants failure, where implant failure is defined as revision, loosening, or any definite change in the position of components (V3-V6).\n* Clinical and functional outcomes, measured with the International Knee Documentation Committee (IKDC) score (V1, V3-V6)\n* Quality of Life, measured with the EQ-5D score (V1, V3-V6)\n* Occurrence of intraoperative and postoperative complications (V2-V6)\n\nDepending on standard practice, imaging assessment of implants and bone tunnels may be performed.\n\nA web-based data collection tool will be used as Electronic Data Capture (EDC). All the information required by the protocol will be collected in electronic case report forms (eCRF).\n\nThe statistical analysis will be performed according to a pre-established statistical analysis plan. Missing values will not be replaced by estimated values but will be considered as missing in the statistical analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients requiring ACL reconstruction and who are suitable to receive M-ARS ACL will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years\n* Patients with ACL rupture requiring ACL reconstruction\n\nExclusion Criteria:\n\n* Patients with malignant diseases (at the time of surgery)\n* Patients with proven or suspected infections (at the time of surgery)\n* Patients with functional deficits of the affected extremity (at the time of surgery)\n* Patients with known incompatibility or allergy to products materials (at the time of surgery)'}, 'identificationModule': {'nctId': 'NCT04462458', 'briefTitle': 'M-ARS ACL Post-marketing Surveillance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medacta International SA'}, 'officialTitle': 'Clinical and Radiological Outcomes of M-ARS ACL', 'orgStudyIdInfo': {'id': 'P07.001.01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Medacta Anatomic Ribbon Surgery (M-ARS ACL)', 'type': 'DEVICE', 'description': 'M-ARS ACL allows to reconstruct the anterior cruciate ligament using the Anatomic Ribbon Technique'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christian Fink, Prof. Dr. med.', 'role': 'CONTACT'}], 'facility': 'Praxis Gelenkpunkt - Sport- und Gelenkchirurgie', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '4560', 'city': 'Kirchdorf an der Krems', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Simone Danese, OA Dr.', 'role': 'CONTACT'}], 'facility': 'Pyhrn-Eisenwurzen Klinikum Kirchdorf', 'geoPoint': {'lat': 47.90558, 'lon': 14.12228}}, {'zip': '81369', 'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'OCM Klinik GmbH', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'centralContacts': [{'name': 'Denise Falcone', 'role': 'CONTACT', 'email': 'falcone@medacta.ch', 'phone': '+41916966060'}], 'overallOfficials': [{'name': 'Mirco Herbort, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OCM Klinik GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medacta International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}