Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-30 @ 7:32 AM
Study NCT ID:
NCT05806034
Status:
UNKNOWN
Last Update Posted:
2023-04-10
First Post:
2023-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 297}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2023-03-28', 'studyFirstSubmitQcDate': '2023-03-28', 'lastUpdatePostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anisotropy score after tractography MRI sequence', 'timeFrame': 'one day', 'description': 'Anisotropy coefficient value is between 0 (isotropic medium) to 1 (fibrillar medium) .\n\nAnisotropy coefficient =0 is for total ACL rupture Anisotropy coefficient between 0 end 0.8 is for partial ACL rupture'}, {'measure': 'Correlation between anisotropy coefficient and ACL lesion state', 'timeFrame': 'one year', 'description': 'Anisotropy coefficient value is between 0 (isotropic medium) to 1 (fibrillar medium) .\n\nAnisotropy coefficient =0 is for total ACL rupture ACL lesion state are No lesion, Partial tear or Complete tear'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ACL Injury', 'MRI', 'tractography'], 'conditions': ['ACL Injury', 'MRI', 'Tractography']}, 'descriptionModule': {'briefSummary': 'Knees injuries commonly affect the ACL. French current methodology is based on MRI focused on the knee with morphological sequences (T1, DP fat sat) allowing the study of ACL as follows: No lesion / Partial tear / Complete tear.\n\nThe treatment (kinesitherapy, surgery, no intervention) is defined taking into account several factors such as age, knee laxity, physical activity and outcome of the radiology analysis (partial or complete tear). However, if the classification is straightforward in case of complete tear, it is not possible to establish a quantitative impact on the ACL in case of partial tear. As a consequence, the investigators will analyze the anisotropy coefficient with diffusion tractography. Any patient who undergo a posttraumatic knee MRI at the CHU Amiens Picardie will have an appointment at the 3T "Signa" MRI that has the knee-centric diffusion tractography sequence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old,\n* Patient referred for non-enhanced knee MRI for traumatism.\n* Affiliation to a social security program,\n\nExclusion Criteria:\n\n* Person under guardianship or curators,\n* Any contraindications to MRI'}, 'identificationModule': {'nctId': 'NCT05806034', 'acronym': 'TRACTOLCA', 'briefTitle': 'Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography', 'orgStudyIdInfo': {'id': 'PI2022_843_0098'}}, 'armsInterventionsModule': {'interventions': [{'name': 'tractography MRI sequence protocol', 'type': 'OTHER', 'description': 'tractography MRI sequence protocol does not require injection of contrast agent.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Wesley BOCQUET, MD', 'role': 'CONTACT', 'email': 'bocquet.wesley@chu-amiens.fr', 'phone': '03 22 03 85 21'}], 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Wesley BOCQUET, MD', 'role': 'CONTACT', 'email': 'bocquet.wesley@chu-amiens.fr', 'phone': '03 22 03 85 21'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}