Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-01 @ 7:25 AM
Study NCT ID:
NCT06316050
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2024-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrovertion Assesment and Study in Elderly Patients With Reverse Total Shoulder Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}, {'id': 'D000070656', 'term': 'Rotator Cuff Tear Arthropathy'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D002805', 'term': 'Chondrocalcinosis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Open randomized controlled clinical trial.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2024-01-16', 'studyFirstSubmitQcDate': '2024-03-15', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'INTERNAL ROTATION', 'timeFrame': '2 YEARS', 'description': 'AT THE SIDE (HAND TO the BACK from CONSTANT TEST)'}, {'measure': 'INTERNAL ROTATION', 'timeFrame': '2 YEARS', 'description': 'degrees'}], 'secondaryOutcomes': [{'measure': 'EXTERNAL ROTATION', 'timeFrame': '2 YEARS', 'description': 'degrees'}, {'measure': 'FORWARD ELEVATION', 'timeFrame': '2 YEARS', 'description': 'degrees'}, {'measure': 'Simple shoulder test', 'timeFrame': '2 years', 'description': '0-100'}, {'measure': 'Constant test', 'timeFrame': '2 years', 'description': '0-100'}, {'measure': 'ASES test', 'timeFrame': '2 years', 'description': '0-100'}, {'measure': 'Glenoid inclination angle', 'timeFrame': '2 years', 'description': 'degrees'}, {'measure': 'glenoid retroversion angle', 'timeFrame': '2 years', 'description': 'degrees'}, {'measure': 'abduction', 'timeFrame': '2 years', 'description': 'degrees'}, {'measure': 'center of rotation', 'timeFrame': '2 years', 'description': 'milimiters'}, {'measure': 'lateralizaiton offset', 'timeFrame': '2 years', 'description': 'milimiters'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Tears', 'Rotator Cuff Tear Arthropathy']}, 'descriptionModule': {'briefSummary': 'Determine the optimal degree of retroversion (0-30º) to obtain the best rotational mobility, both internal and external, of the shoulder after implanting a reversed sghoulder arthroplasty (Comprehensive system), and analyze the functional and radiologic results based on humeral retroversion.', 'detailedDescription': "Methodology: Open randomized controlled clinical trial. It will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital from January 2019 to June 2021. The estimated sample will be 30 patients per group with diagnosis of massive rotator cuff rupture, rotator cuff arthropaty and primary osteoarthritis with cuff injury, with Walch's type B2 glena or in patients older than 80 years. A global study will be carried out preoperatively and postoperatively with radiographs, computerized tomography, magnetic resonance, and a biomechanical study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women over 60 with the diagnosis rotator cuff massive break (Hamada 2 or more), arthrosis secondary to ruptures of the rotator cuff and primary osteoarthritis with lesion of the cuff, with full Walch B2 type or in patients older than 80 years. Inclusion criteria\n* Good functionality of the deltoid muscle.\n* Presence of minor round (Hornblower test - no muscle atrophy in nuclear magnetic resonance)\n* Accept informed consent\n\nExclusion Criteria:\n\n* \\- Review of hemiarthroplasty or anatomical proesis of the affected shoulder.\n* Fracture of shoulder in the upper extremity to intervene.\n* Central neurological diseases\n* Advanced cognitive impairment\n* Brachial plexus injuries\n* Local or systemic infection.\n* Oncological disease\n* Treatment with immunosuppressants.'}, 'identificationModule': {'nctId': 'NCT06316050', 'briefTitle': 'Retrovertion Assesment and Study in Elderly Patients With Reverse Total Shoulder Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Consorci Sanitari de Terrassa'}, 'officialTitle': 'Retrovertion Assesment and Study of the Subscapularis Function in Elderly Patients With Reverse Total Shoulder Arthroplasty', 'orgStudyIdInfo': {'id': 'cst'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'humeral retroversion 0º', 'description': 'will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital', 'interventionNames': ['Procedure: humeral retroversion']}, {'type': 'NO_INTERVENTION', 'label': 'humeral retroversion 30º', 'description': 'will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital'}], 'interventions': [{'name': 'humeral retroversion', 'type': 'PROCEDURE', 'description': 'REVERSED SHOULDER ARTHROPLASTY IN TWO DIFFERENT GROUPS. Group 0 humeral retroversion, Group 30º humeral retroversion', 'armGroupLabels': ['humeral retroversion 0º']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08227', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'JM MORA', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Consorci Sanitari de Terrassa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Shoulder Unit', 'investigatorFullName': 'Josep Maria Mora Guix', 'investigatorAffiliation': 'Consorci Sanitari de Terrassa'}}}}