Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-04-18 @ 7:57 AM
Study NCT ID:
NCT02014350
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2013-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes Following Delta Xtend Reverse Shoulder System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'lastUpdateSubmitDate': '2013-12-17', 'studyFirstSubmitDate': '2013-12-12', 'studyFirstSubmitQcDate': '2013-12-17', 'lastUpdatePostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant Survivorship', 'timeFrame': '10 years post-operative'}]}, 'conditionsModule': {'conditions': ['Reverse Total Shoulder Arthroplasty']}, 'descriptionModule': {'briefSummary': 'To collect medium to long-term survivorship implant outcomes on the DePuy Delta Xtend Reverse Shoulder Stystem.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients who were implanted with the DePuy Delta Xtend Reverse Total Shoulder Arthoplasty between 2008-2012', 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients whom were implanted with the DePuy Delta Xtend Reverse Total Shoulder System in the time frame indicated. Patients must be willing to sign the consent form and complete all follow-up visits.'}, 'identificationModule': {'nctId': 'NCT02014350', 'briefTitle': 'Outcomes Following Delta Xtend Reverse Shoulder System', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'orgStudyIdInfo': {'id': 'RI2013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DePuy Delta Xtend RTSA', 'interventionNames': ['Device: DePuy Delta Xtend Reverse TSA']}], 'interventions': [{'name': 'DePuy Delta Xtend Reverse TSA', 'type': 'DEVICE', 'armGroupLabels': ['DePuy Delta Xtend RTSA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}