Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT04076956
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2019-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Performance and Safety of the Composite Interference Screw Used in Anterior Cruciate Ligament Reconstructions
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'}]}, '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-15', 'size': 662245, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-29T11:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2019-08-28', 'studyFirstSubmitQcDate': '2019-08-29', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of the objective International Knee Documentation Committee score before and after surgery', 'timeFrame': '4 months before surgey / 7 months post-surgery', 'description': 'Record of the objective International Knee Documentation Committee score (A = normal, B = almost normal, C = abnormal or D = very abnormal)'}, {'measure': 'Change of the subjective International Knee Documentation Committee score before and after surgery', 'timeFrame': '4 months before surgey / 7 months post-surgery', 'description': 'Record of the subjective International Knee Documentation Committee score (from 1 to 100 where 100 is the best result)'}], 'secondaryOutcomes': [{'measure': 'Number and precise description of any adverse event during the follow-up', 'timeFrame': 'Before surgery until 7 months post-surgery', 'description': 'Record and description of any adverse event during the follow-up that reflects the safety of the Composite Interference Screw'}, {'measure': 'Change in the patients recovery', 'timeFrame': '2 months post-surgery', 'description': 'Record of recovery informations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee ligament injury', 'Anterior cruciate ligament rupture', 'Anterior cruciate ligament reconstruction', 'Knee ligament rupture', 'Knee ligament reconstruction'], 'conditions': ['Knee Ligament Injury']}, 'descriptionModule': {'briefSummary': "The evaluation of the clinical data has demonstrated the conformity of the Composite Interference Screw (CIS), with the relevant essential requirements for its use in orthopaedic applications. The Composite Interference Scres are intended for tibial and femoral ligament/graft fixation in the case or Anterior Cruciate Ligament (ACL) reconstructions. It has been concluded that the risks associated with the use of the device are acceptable when weighted against the benefits to the patients. In order to improve the clinical data on the CIS, the manufacturer, Biomatlante, decided to assess that the performance and safety of the device are maintained until the reaching of its intended use. In this objective, the goal of this study will be to observe the following parameters:\n\n1. Objective IKDC score (clinical evaluation)\n2. Subjective IKDS score (functional evaluation)\n3. Safety (report of any adverse event)\n4. Follow-up of the patient's recovery"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is considered as all the patients included in the study that meet the inclusion and exclusion criteria.\n\nThe study population is composed of 56 patients according to the protocol.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute or chronic ACL deficiency with complete or partial lesion of the anteromedial bundle requiring primary reconstruction of the Anterior Cruciate Ligament with hamstring tendons\n* Males or females aged froù 18 to 60 years\n* No history of surgery on the affected knee\n* Patients not under guardianship or judicial protection\n* Signature of non opposition form (consent of the patient\n\nExclusion Criteria:\n\n* History of ligament, meniscal surgery or fracture of the affected knee\n* Pregnancy of breastfeeding women'}, 'identificationModule': {'nctId': 'NCT04076956', 'briefTitle': 'Performance and Safety of the Composite Interference Screw Used in Anterior Cruciate Ligament Reconstructions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biomatlante'}, 'officialTitle': 'Performance and Safety of the Composite Interference Screw Used in Anterior Cruciate Ligament Reconstructions', 'orgStudyIdInfo': {'id': '2018-A03211-54'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Anterior Cruciate Ligament Reconstruction', 'type': 'DEVICE', 'description': 'Reconstruction of the Anterior Cruciate Ligament using an interference screw'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13008', 'city': 'Marseille', 'state': 'PACA', 'country': 'France', 'facility': 'Clinique JUGE', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Jaafar JS SBIHI, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Juge'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biomatlante', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Atlanstat', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}