Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT05791656
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2023-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interference Screw Mectascrew-C Postmarket Study
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-30', 'studyFirstSubmitDate': '2023-03-07', 'studyFirstSubmitQcDate': '2023-03-17', 'lastUpdatePostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interference screw presence', 'timeFrame': '6 months', 'description': 'via MRI imaging at 6 months after surgery, the presence of the Mectascrew-C will be assessed'}], 'secondaryOutcomes': [{'measure': 'Mobility outcomes evaluation', 'timeFrame': '1, 3 and 6 months', 'description': 'Assessment throught Range Of Motion of operated knee calculated as degree'}, {'measure': 'Functional outcomes evaluation', 'timeFrame': '1, 3 and 6 months', 'description': 'Assessment throught IKCD score. a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).'}, {'measure': 'Knee stability evaluation of ACL intervention', 'timeFrame': '1, 3 and 6 months', 'description': 'Pivot shift test. A positive test indicate an injury at ACL'}, {'measure': 'ACL integrity assessment', 'timeFrame': '1, 3 and 6 months', 'description': 'Anterior drawer test. An anterior translation more than 6 mm indicate a positive test with injuried ACL'}, {'measure': 'Knee stability evaluation of PCL intervention', 'timeFrame': '1, 3 and 6 months', 'description': 'Reverse Pivot Shift test. In the presence of a posterolateral injury with the knee flexed, the tibia follows gravity and drops into posterolateral subluxation (positive Reverse Pivot Shift Test).'}, {'measure': 'PCL integrity assessment', 'timeFrame': '1, 3 and 6 months', 'description': 'Posterior drawer test. The test is considered positive if there is a lack of end feel or excessive posterior translation.'}, {'measure': 'Device safety evaluation', 'timeFrame': '1, 3 and 6 months', 'description': 'collection of adverse event'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Injuries', 'Posterior Cruciate Ligament Tear']}, 'descriptionModule': {'briefSummary': 'An observational prospective study with the aim to analyze the presence at 6 months of a specific composite IS (Medacta Mectascrew C) in the reconstructive treatment of ruptured ACL or PCL by means of an autograft or allograft.', 'detailedDescription': "This is an observational prospective study with the aim to determine the presence of the composite IS (Mectascrew-C) at 6 months following ACL or PCL reconstruction.\n\nPatients with an ACL or PCL tear scheduled for surgery at one of the EOC's hospitals will be enrolled in the study, after the subscription of informed consent. The injured ligament will be restored with an auto- or allograft that will be fixed with a composite IS (Mectascrew-C, 70% PLDLLA, 30% β-TCP, Medacta International SA).\n\nThe data will be collected from patient's medical histories (data about diagnosis, patients' characteristics and surgery) and after operation, during the orthopaedic follow-up visits, planned at 1, 3 and 6 months, in order to assess the functional outcomes (IKDC objective and subjective) and the knee stability (ROM, Pivot Shift or Reverse Pivot Shift test, anterior or posterior drawer test) of the patients.\n\nThe treated knee will be also evaluated radiologically with an MRI at 6 months to assess the IS reabsorption. The results of this exam will be correlated to the pre-operative findings and to the functional and clinical outcomes evaluated with the different forms"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with an ACL or PCL rupture, and meeting the inclusion/exclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes aged 16-60 yrs\n* Pre-operative MRI confirming the ACL or PCL rupture\n* Scheduled for surgical reconstruction of ACL or PCL\n* BMI\\>18 and \\<35 kg/m2\n* Ability to give informed consent by signature\n\nExclusion Criteria:\n\n* Age under 16 or over 60 yrs\n* Degenerative osteopathies\n* Local bone tumors\n* Deformities of the bone, or general conditions of the bone, which preclude the implantation in the opinion of a physician\n* Systemic diseases and metabolic disorders that may compromise the outcome of the surgery'}, 'identificationModule': {'nctId': 'NCT05791656', 'briefTitle': 'Interference Screw Mectascrew-C Postmarket Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medacta International SA'}, 'officialTitle': 'Composite Interference Screw in the Surgical Reconstruction of Knee Cruciate Ligaments: a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'P07.001.09'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mectascrew-C', 'type': 'DEVICE', 'description': 'reconstruction of ACL or PCL rupture'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-6962', 'city': 'Lugano', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Alessandro Sangiorgio, Dr', 'role': 'CONTACT', 'email': 'Alessandro.Sangiorgio@eoc.ch'}, {'name': 'Christian Candrian, Prof Dr Med', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'EOC, Service of Orthopaedics and Traumatology', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}], 'centralContacts': [{'name': 'Elisa Bonacina, PhD', 'role': 'CONTACT', 'email': 'bonacina@medacta.ch', 'phone': '+41 91 696 60 60'}], 'overallOfficials': [{'name': 'Christian Candrian, Prof Med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'EOC , Service of Orthopaedics and Traumatology, Lugano (Switzerland)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medacta International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}