Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-04-19 @ 7:41 AM
Study NCT ID:
NCT02305966
Status:
UNKNOWN
Last Update Posted:
2017-03-24
First Post:
2014-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Implant Fixation in Reverse Total Shoulder Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-22', 'studyFirstSubmitDate': '2014-10-30', 'studyFirstSubmitQcDate': '2014-12-02', 'lastUpdatePostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'migration between cemented and press-fit RTSA humeral components detected by Radiostereometric analysis', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'difference in component migration between conventional and lateralized glenoid components detected by Radiostereometric analysis', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['advanced arthritis', 'shoulder'], 'conditions': ['Arthritis']}, 'descriptionModule': {'briefSummary': 'Reverse total shoulder replacement surgery (RTSA) is performed for individuals with advanced arthritis of the shoulder who also have tears in their rotator cuff muscles. A metal hemisphere is placed in the shoulder blade, and a plastic cup on a stem is placed in the upper arm. This orientation is opposite to the normal anatomy, giving rise to the term "reverse" shoulder replacement. While RTSA has a good clinical track record, no studies have examined how well fixed the implanted components are within patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* will be any patient with cuff tear arthropathy requiring reverse shoulder arthroplasty.\n\nExclusion Criteria:\n\n* will be any patient with a previous RTSA or TSA (i.e. no revision surgery) or anyone unable to return for RSA imaging (e.g. living \\>100 km outside of London).'}, 'identificationModule': {'nctId': 'NCT02305966', 'briefTitle': 'Evaluation of Implant Fixation in Reverse Total Shoulder Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Evaluation of Implant Fixation in Reverse Total Shoulder Arthroplasty', 'orgStudyIdInfo': {'id': '7519'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'pressfit humerus & non-lateralized glenoid', 'description': 'All patients will receive a Delta XTEND reverse shoulder implant (DePuy Synthes, Warsaw, IN). At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant, (n = 6 surrounding the glenoid and n = 6 surrounding the proximal humerus). Half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a cemented humeral component, and half will be randomized to receive a press-fit (uncemented). Similarly, half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a lateralized glenoid component, and half will be randomized to receive a non-lateralized glenoid component.Therefore, 4 randomization groups will be created and one of them is -pressfit humerus \\& non-lateralized glenoid.', 'interventionNames': ['Procedure: surgery', 'Device: 0.8 mm diameter Tantalum marker beads']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pressfit humerus & lateralized glenoid', 'description': 'All patients will receive a Delta XTEND reverse shoulder implant (DePuy Synthes, Warsaw, IN). At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant, (n = 6 surrounding the glenoid and n = 6 surrounding the proximal humerus). Half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a cemented humeral component, and half will be randomized to receive a press-fit (uncemented). Similarly, half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a lateralized glenoid component, and half will be randomized to receive a non-lateralized glenoid component.Therefore, 4 randomization groups will be created and one of them is - pressfit humerus \\& lateralized glenoid.', 'interventionNames': ['Procedure: surgery', 'Device: 0.8 mm diameter Tantalum marker beads']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'cemented humerus & non-lateralized glenoid', 'description': 'All patients will receive a Delta XTEND reverse shoulder implant (DePuy Synthes, Warsaw, IN). At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant, (n = 6 surrounding the glenoid and n = 6 surrounding the proximal humerus). Half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a cemented humeral component, and half will be randomized to receive a press-fit (uncemented).Similarly, half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a lateralized glenoid component, and half will be randomized to receive a non-lateralized glenoid component. Therefore, 4 randomization groups will be created and one of them is cemented humerus \\& non-lateralized glenoid', 'interventionNames': ['Procedure: surgery', 'Device: 0.8 mm diameter Tantalum marker beads']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'cemented humerus & lateralized glenoid.', 'description': 'All patients will receive a Delta XTEND reverse shoulder implant (DePuy Synthes, Warsaw, IN). At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant, (n = 6 surrounding the glenoid and n = 6 surrounding the proximal humerus). Half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a cemented humeral component, and half will be randomized to receive a press-fit (uncemented).Similarly, half of the patients (n = 20) will be randomized by an opaque envelope intra-operatively to receive a lateralized glenoid component, and half will be randomized to receive a non-lateralized glenoid component.Therefore, 4 randomization groups will be created and one of them is cemented humerus \\& lateralized glenoid.', 'interventionNames': ['Procedure: surgery', 'Device: 0.8 mm diameter Tantalum marker beads']}], 'interventions': [{'name': 'surgery', 'type': 'PROCEDURE', 'description': 'All patients will receive a Delta XTEND reverse shoulder implant', 'armGroupLabels': ['cemented humerus & lateralized glenoid.', 'cemented humerus & non-lateralized glenoid', 'pressfit humerus & lateralized glenoid', 'pressfit humerus & non-lateralized glenoid']}, {'name': '0.8 mm diameter Tantalum marker beads', 'type': 'DEVICE', 'description': 'At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant,', 'armGroupLabels': ['cemented humerus & lateralized glenoid.', 'cemented humerus & non-lateralized glenoid', 'pressfit humerus & lateralized glenoid', 'pressfit humerus & non-lateralized glenoid']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kate Kelly, M.Sc,MPH/Gero', 'role': 'CONTACT', 'email': 'Kate.Kelly@sjhc.london.on.ca', 'phone': '519-646-6100', 'phoneExt': '64640'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'George Athwal', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}