Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-02-17 @ 5:51 PM
Study NCT ID:
NCT01873651
Status:
WITHDRAWN
Last Update Posted:
2014-08-11
First Post:
2013-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longterm Outcome of the Delta III Inverse Prosthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070656', 'term': 'Rotator Cuff Tear Arthropathy'}], 'ancestors': [{'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study has been withdrawn due to too few patients', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-08', 'studyFirstSubmitDate': '2013-06-05', 'studyFirstSubmitQcDate': '2013-06-05', 'lastUpdatePostDateStruct': {'date': '2014-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Constant Murley Score', 'timeFrame': '10 years'}], 'secondaryOutcomes': [{'measure': 'cASES', 'timeFrame': '10 years'}, {'measure': 'pASES', 'timeFrame': '10 years'}, {'measure': 'SF-36', 'timeFrame': '10 years'}, {'measure': 'DASH-Questionannaire', 'timeFrame': '10 years'}, {'measure': 'SPADI', 'timeFrame': '10 years'}, {'measure': 'x-ray (Sperling Classification)', 'timeFrame': '10 years'}, {'measure': 'x-ray (Sirveaux Classification)', 'timeFrame': '10 years'}, {'measure': 'Description of the glenoid', 'timeFrame': '10 years', 'description': 'Description of the situation:\n\ne.g.\n\n* any dissociation of the gleonid\n* any migration of the glenoid'}, {'measure': 'Description of the stem', 'timeFrame': '10 years', 'description': 'Description of the situation:\n\ne.g.\n\n\\- change of the position'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Tear Arthropathy']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to describe the results after \\> 10 years due to a prosthesis implant.', 'detailedDescription': 'The aim of the study is to measure the gain of the benefit in function an painreduction which the patient yields with this type of prosthesis in a longterm (\\> 10 years )outcome. Additionally the long-term results will be compared with the mid-term results and the literature. Furthermore the complications since the mid-term measurement time point will be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* implantation of a Delta III - prothesis\n* timeframe (Oct 1998 - Dec 2002)\n* delta-pectoral approach\n* written informed consent\n\nExclusion Criteria:\n\n* Implantation because of a revision\n* Complaints, which make it difficult to follow instructions or even prevent'}, 'identificationModule': {'nctId': 'NCT01873651', 'briefTitle': 'Longterm Outcome of the Delta III Inverse Prosthesis', 'organization': {'class': 'OTHER', 'fullName': 'Schulthess Klinik'}, 'officialTitle': 'The Reverse Delta III Total Shoulder Prosthesis - Longerm Results in 98 Patients', 'orgStudyIdInfo': {'id': 'Delta III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Delta III', 'description': 'Implantation of a Delta III Prosthesis', 'interventionNames': ['Device: Implantation of a Delta III Prosthesis']}], 'interventions': [{'name': 'Implantation of a Delta III Prosthesis', 'type': 'DEVICE', 'description': 'Implantation of a Delta III Prosthesis', 'armGroupLabels': ['Delta III']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Matthias Flury, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schulthess Klinik, Upper Extremities Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schulthess Klinik', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator (Department of Upper Extremity)', 'investigatorFullName': 'Matthias Flury', 'investigatorAffiliation': 'Schulthess Klinik'}}}}