Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-27 @ 9:07 AM
Study NCT ID:
NCT05725603
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Anatomical Evaluation of Healing of Lesions of the Subscapular Tendon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070599', 'term': 'Shoulder Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-17', 'studyFirstSubmitDate': '2023-02-02', 'studyFirstSubmitQcDate': '2023-02-02', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tendon scarring', 'timeFrame': '1 day', 'description': 'Tendon scarring is based on the Sugaya classification from an MRI'}], 'secondaryOutcomes': [{'measure': 'Fatty infiltration', 'timeFrame': '1 day', 'description': "The fatty infiltration of the subscapularis muscle is evaluated according to Goutallier's classification"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Injuries']}, 'descriptionModule': {'briefSummary': 'This study is based on the hypothesis that fatty infiltration postoperative is not or only slightly modified after an atomic repair of lesions of the subscapularis tendon according to a new arthroscopic classification.', 'detailedDescription': 'After repair of isolated lesions of the subscapularis, it is observed, in nearly half of the cases, a increased fatty infiltration of the subscapularis muscle indicating a probable persistence of the tendon rupture while the Healing failure rate is recognized as moderate (about 15%).\n\nThis study is based on the hypothesis that fatty infiltration postoperative is not or only slightly modified after an atomic repair of lesions of the subscapularis tendon according to a new arthroscopic classification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient, male or female, aged ≥ 18 years\n* Patient who has undergone surgical repair for a rupture or rotator cuff injury involving the subscapularis tendon between April and September 2016 and between May 2018 and January 2019\n* Patient with a lesion of the subscapularis tendon characterized with arthroscopic classification\n* Patient who has previously participated in the classification study of subscapularis tendon injuries based on findings arthroscopy conducted only at the Jean Mermoz Hospital\n\nExclusion Criteria:\n\n* Patient with a contraindication to MRI'}, 'identificationModule': {'nctId': 'NCT05725603', 'acronym': 'TENDICICA', 'briefTitle': 'Clinical and Anatomical Evaluation of Healing of Lesions of the Subscapular Tendon', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Clinical and Anatomical Evaluation of Healing of Lesions of the Subscapular Tendon', 'orgStudyIdInfo': {'id': '2022-A02504-39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shoulder MRI', 'description': 'Shoulder MRI will be performed at least 3 years after shoulder surgery', 'interventionNames': ['Other: MRI imaging']}], 'interventions': [{'name': 'MRI imaging', 'type': 'OTHER', 'description': 'Shoulder MRI will be performed at least 3 years after shoulder surgery', 'armGroupLabels': ['Shoulder MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69008', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent NOVE JOSSERAND, MD', 'role': 'CONTACT', 'email': 'lnovejosserand.md@orthosanty.fr', 'phone': '+33437530024'}], 'facility': 'Hôpital Privé Jean Mermoz', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Laurent NOVE JOSSERAND, MD', 'role': 'CONTACT', 'email': 'lnovejosserand.md@orthosanty.fr', 'phone': '+ 33 4 37 53 00 24'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}