Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-12 @ 8:22 AM
Study NCT ID:
NCT01877434
Status:
COMPLETED
Last Update Posted:
2013-06-13
First Post:
2013-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reversed TESS Shoulder Artroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006810', 'term': 'Humeral Fractures'}], 'ancestors': [{'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-11', 'studyFirstSubmitDate': '2013-06-11', 'studyFirstSubmitQcDate': '2013-06-11', 'lastUpdatePostDateStruct': {'date': '2013-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Arm lenght difference', 'timeFrame': '2007-2013', 'description': 'Impact on arm lenght difference on patient reported outcome evaluated with Quick-DASH'}], 'primaryOutcomes': [{'measure': 'Patient reported outcome measurement Quick-DASH', 'timeFrame': '2007-2013'}], 'secondaryOutcomes': [{'measure': 'Range of movement', 'timeFrame': '2007-2013'}, {'measure': 'Quality of life EQ5-D', 'timeFrame': '2007-2013'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Reversed shoulder arthroplasty', 'Treatment', 'TESS'], 'conditions': ['Humerus Fracture', 'Degenerative Shoulder Pain', 'Degenerative Supraspinatus Rupture']}, 'descriptionModule': {'briefSummary': 'Reverse total shoulder arthroplasty (RSA) is a accepted treatment for different shoulder diseases with improved functional outcome. This study has evaluated patients operated with reversed shoulder arthroplasty after 1,5-3 years postoperatively with patient reported outcome, clinical and radiological examination, complication and reoperations. The radiologic phenomenom and clinical impact of scapular notching (SN) and arm length difference has been evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergone reversed shoulder arthroplasty at Sundsvall hospital, Sweden between 2007-2012', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Operated with a reversed TESS total shoulder arthroplasty at Sundsvall hospital.\n\nExclusion Criteria:\n\n* Do not give informed consent\n* Do not attend follow-up'}, 'identificationModule': {'nctId': 'NCT01877434', 'acronym': 'RTESS', 'briefTitle': 'Reversed TESS Shoulder Artroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Sundsvall Hospital'}, 'officialTitle': 'The TESS Reverse Shoulder Arthroplasty: Effect of Arm Lengthening and Early Scapular Notching at Three Years Follow-up', 'orgStudyIdInfo': {'id': '2012-201-31M'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Reversed TESS', 'description': 'Patient undergone reversed shoulder arthroplasty', 'interventionNames': ['Procedure: Reversed shoulder arthroplasty']}], 'interventions': [{'name': 'Reversed shoulder arthroplasty', 'type': 'PROCEDURE', 'armGroupLabels': ['Reversed TESS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sundsvall', 'state': 'Västernorrland Län', 'country': 'Sweden', 'facility': 'Institution of surgical and operative sciences, Umeå University', 'geoPoint': {'lat': 62.39129, 'lon': 17.3063}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sundsvall Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultat medical doctor', 'investigatorFullName': 'Lennart Bråbäck', 'investigatorAffiliation': 'Sundsvall Hospital'}}}}