Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT06058494
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2016-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-scale Modeling for Predictive Characterization of Ligaments and Grafts Behavior in ACL Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2016-05-25', 'studyFirstSubmitQcDate': '2023-09-22', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics', 'timeFrame': 'At baseline', 'description': 'Active movements will be acquired by dynamic Roentgen Stereophotogrammetric Analysis (RSA) before and after surgery; joint dynamics will be estimated by analyzing Ground Reaction Force, applying inverse dynamics modeling. Navigation system will intra-operatively acquire passive joint kinematics. Clinical assessement will be performed: subjective (KOOS, SF-12) and objective (IKDC, Marx) ones.'}, {'measure': 'Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics', 'timeFrame': '4 months', 'description': 'Active movements will be acquired by dynamic Roentgen Stereophotogrammetric Analysis (RSA) before and after surgery; joint dynamics will be estimated by analyzing Ground Reaction Force, applying inverse dynamics modeling. Navigation system will intra-operatively acquire passive joint kinematics. Clinical assessement will be performed: subjective (KOOS, SF-12) and objective (IKDC, Marx) ones.'}, {'measure': 'Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics', 'timeFrame': '18 months', 'description': 'Active movements will be acquired by dynamic Roentgen Stereophotogrammetric Analysis (RSA) before and after surgery; joint dynamics will be estimated by analyzing Ground Reaction Force, applying inverse dynamics modeling. Navigation system will intra-operatively acquire passive joint kinematics. Clinical assessement will be performed: subjective (KOOS, SF-12) and objective (IKDC, Marx) ones.'}], 'secondaryOutcomes': [{'measure': 'Functional and Anatomical Model', 'timeFrame': 'at 4 months', 'description': 'MRI scans with T2 mapping will be performed on each patient to acquire the anatomical features, define the cartilage and graft status.'}, {'measure': 'Functional and Anatomical Model', 'timeFrame': '18 months', 'description': 'MRI scans with T2 mapping will be performed on each patient to acquire the anatomical features, define the cartilage and graft status.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anterior Cruciate Ligament', 'Reconstruction', 'Ligament modeling'], 'conditions': ['Anterior Cruciate Ligament Reconstruction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ior.it', 'label': 'Institutional Website'}]}, 'descriptionModule': {'briefSummary': 'The objective of this clinical trial is provide in vivo data thus to model the ligament biomechanical behavior within the physiologically healthy joint and to use the implemented model to predict risk and success rates focusing on knee joint Anterior Cruciate Ligament (ACL) reconstruction. Current ACL surgery offers 3 alternatives: autografts, allografts and bioengineered grafts; the choice of the implant and its characteristics still remains a critical point. The knowledge of patient-specific joint and graft biomechanics is fundamental to reduce surgical revision rate and low functional outcome. This clinical trial will provide data coming from patient-specific biomechanics into a prognostic computational model, able to provide information on both the optimal customized reconstruction and graft status during the early rehabilitation phase. This patient-specific approach will lead to quicker return to sports activity, reducing also the possibility of early osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with primary lesion of the anterior cruciate ligament (ACL), assessed by clinical manouvers and confirmed by means of MRI.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary ACL lesion\n* Ability to read and sign the informed consent.\n* Age between 16 and 50 years old\n\nExclusion Criteria:\n\n* Prior surgeries at the same knee\n* Grade II or higher lesions at the collateral ligaments\n* Posterior Cruciate Ligament lesion\n* Inflammatory arthritis or other forms systemic inflammatory diseases\n* Local or systemic infections\n* Any injury or condition that adversely affects the ability to walk or to participate to I/II level activities\n* Previous or concomitant lesions at the contralateral knee\n* Skeletal immaturity\n* Other potential risk factors for the development of osteoarthritis'}, 'identificationModule': {'nctId': 'NCT06058494', 'acronym': 'MULTI-ACL', 'briefTitle': 'Multi-scale Modeling for Predictive Characterization of Ligaments and Grafts Behavior in ACL Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Multi-scale Modeling for Predictive Characterization of Ligaments and Grafts Behavior in ACL Reconstruction', 'orgStudyIdInfo': {'id': '0023352'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single-Bundle', 'description': 'Single-bundle ACL reconstruction', 'interventionNames': ['Procedure: Anterior Cruciate Ligament Reconstruction']}, {'label': 'Single-Bundle+Lateral Plasty', 'description': 'Single-bundle ACL reconstruction with lateral plasty', 'interventionNames': ['Procedure: Anterior Cruciate Ligament Reconstruction']}, {'label': 'Double-Bundle', 'description': 'Double-bundle ACL reconstruction', 'interventionNames': ['Procedure: Anterior Cruciate Ligament Reconstruction']}], 'interventions': [{'name': 'Anterior Cruciate Ligament Reconstruction', 'type': 'PROCEDURE', 'description': 'Reconstruction of the anterior cruciate ligament by means of the three reported techniques, namely single-bundle, single-bundle with extraarticular tenodesis and anatomic double-bundle.', 'armGroupLabels': ['Double-Bundle', 'Single-Bundle', 'Single-Bundle+Lateral Plasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'state': 'BO', 'country': 'Italy', 'facility': 'Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Stefano Zaffagnini, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Ortopedico Rizzoli'}, {'name': 'Nicola Francesco Lopomo, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istituto Ortopedico Rizzoli'}, {'name': 'Cecilia Signorelli, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Istituto Ortopedico Rizzoli'}, {'name': 'Marco Bontempi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Istituto Ortopedico Rizzoli'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Italy', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}