Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT03445494
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2018-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shoulder Abduction Brace Against Normal Sling After Arthroscopical Rotator Cuff Suture.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001915', 'term': 'Braces'}], 'ancestors': [{'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized 1:1'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2018-01-22', 'studyFirstSubmitQcDate': '2018-02-20', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy in the rehabilitative therapy', 'timeFrame': '6 months', 'description': 'The primary objective of the study is to evaluate two different rehabilitative therapies. Efficacy is measured with a pre and post MRI'}], 'secondaryOutcomes': [{'measure': 'Quality of life assessment', 'timeFrame': '6 months', 'description': 'Evaluation of the quality of live in both groups through Constant Quality of Life questionnair up to 6 months'}, {'measure': 're-rupture rate of the supraspinatus tendon', 'timeFrame': '6 months', 'description': 'Evaluation of the re-rupture of the supraspinatus tendon though a follow up MRI at 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Supraspinatus Injury']}, 'descriptionModule': {'briefSummary': 'The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the surgery, the patient will be randomized into group A (brace) or group B (normal sling).\n\nBoth groups will be also treated according to standard of care with physiotherapy and progressive introduction of movements.', 'detailedDescription': 'The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the surgery, the patient will be randomized into group A (brace) or group B (normal sling).\n\nBoth groups will then perform only passive movements according to pain for the first 6 weeks supported by the physiotherapy, according to standard therapy. The following six weeks passive movements will be associated with active movements . No brace nor normal sling will be used anymore.\n\nPatients are in study for 6 months. During this period quality of life and pain questionnaires are submitted to the patients and a MRI will be done at the end of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '72 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females between 18 and 65 years old;\n* Presence of an isolated lesion of supraspinatus that can be documented with the MRI and which can be treated surgically by arthroscopy;\n* Presence of a supraspinatus lesion according to the Patte criteria with stage 1, 2 or 3 frontal plane ;\n* Presence of adipose degeneration ≤ 2 according to Goutallier;\n* Written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Presence of a lesion of other rotator cuff tendons;\n* Previous surgical procedures of the shoulder;\n* Presence of a massive lesion, therefore irreparable, of the cuff detected intra-operatively and not observed during preoperative MRI;\n* Presence of relapsing shoulder dislocations;\n* Presence of lesions of the glenoidine cercine that require intervention;\n* Difficulties to follow the rehabilitation programs;\n* Presence of neoplastic diseases, metabolic diseases, inflammatory and systemic diseases, autoimmune diseases and immunosuppressed patients;\n* State of pregnancy (presumed or established) or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT03445494', 'briefTitle': 'Shoulder Abduction Brace Against Normal Sling After Arthroscopical Rotator Cuff Suture.', 'organization': {'class': 'OTHER', 'fullName': 'Ente Ospedaliero Cantonale, Bellinzona'}, 'officialTitle': 'Shoulder Abduction Brace Against Normal Sling After Arthroscopical Rotator Cuff Suture: a Randomized Monocentric Study', 'orgStudyIdInfo': {'id': 'ORL-ORT-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brace', 'description': 'After surgery the patient must wear the brace for 6 weeks, for the first 3 weeks during day and night and for the following 3 weeks only at night', 'interventionNames': ['Procedure: Brace']}, {'type': 'EXPERIMENTAL', 'label': 'Normal sling', 'description': 'After surgery the patient must wear the normal sling for two weeks', 'interventionNames': ['Procedure: Normal sling']}], 'interventions': [{'name': 'Brace', 'type': 'PROCEDURE', 'description': 'A brace to be weared according to protocol', 'armGroupLabels': ['Brace']}, {'name': 'Normal sling', 'type': 'PROCEDURE', 'description': 'A normal sling to be weared according to protocol', 'armGroupLabels': ['Normal sling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6900', 'city': 'Lugano', 'country': 'Switzerland', 'facility': 'Ente Ospedaliero Cantonale', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}], 'overallOfficials': [{'name': 'Christian Candrian, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'EOC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christian Candrian', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinical Trial Unit Ente Ospedaliero Cantonale', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Deputy Head of Surgery and Orthopedy', 'investigatorFullName': 'Christian Candrian', 'investigatorAffiliation': 'Ente Ospedaliero Cantonale, Bellinzona'}}}}