Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-08 @ 2:50 AM
Study NCT ID:
NCT00477360
Status:
UNKNOWN
Last Update Posted:
2011-08-11
First Post:
2007-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Humeral Resurfacing Hemiarthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-10', 'studyFirstSubmitDate': '2007-05-22', 'studyFirstSubmitQcDate': '2007-05-22', 'lastUpdatePostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American Shoulder And Elbow Surgeons Shoulder Index (ASES)', 'timeFrame': '24 months post-operative'}], 'secondaryOutcomes': [{'measure': 'Constant Score', 'timeFrame': '24 months post-operative'}, {'measure': 'Western Ontario Osteoarthritis of the Shoulder Index (WOOS)', 'timeFrame': '24 months post-operative'}, {'measure': 'Simple Shoulder Test (SST)', 'timeFrame': '24 months post-operative'}, {'measure': 'Radiographic Evaluation', 'timeFrame': '3 months + yearly post-operative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced Glenohumeral Arthritis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to examine quality of life outcomes in patients who have undergone a humeral surface replacement hemiarthroplasty.', 'detailedDescription': 'Resurfacing arthroplasty is gaining popularity for the reconstruction of advanced shoulder arthritis. New generation re-surfacing prostheses are engineered to anatomically restore a smooth articulating surface to the humeral head, while preserving bone stock, and potentially minimizing the risk for diaphyseal fracture. The results for shoulder resurfacing prostheses have largely been reported in retrospective reviews and have been very favorable. The purpose of this multi-centered, prospective study will be to determine the extent to which patient self-assessed outcomes (American Shoulder and Elbow Society (ASES) Score) following humeral resurfacing improve compared to pre-operative ASES scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Pre-Operative Inclusion Criteria:\n\n* Failed standard non-surgical management (analgesics, nsaids, physiotherapy, activity modification)\n* Persistent pain and disability for at least 6 months\n* Imaging demonstrates advanced humeral head cartilage loss\n\nPre-Operative Exclusion Criteria:\n\n* Active or systemic joint infection\n* Significant muscle paralysis of shoulder girdle\n* Charcot's Arthropathy\n* Major medical illness (life expectancy \\<2years)\n* Unable to speak and read English/French\n* Psychiatric illness that precludes informed consent\n* Unwilling/unable to remain in study for one year\n\nIntra-Operative Inclusion Criteria:\n\nAdvanced humeral head cartilage loss AND ONE of:\n\n* minimal/no glenoid cartilage loss\n* complete glenoid cartilage loss and no bony erosion\n* complete glenoid cartilage loss and concentric bony erosion with no humeral anterior/posterior subluxation\n\nIntra-Operative Exclusion Criteria:\n\n* Eccentric glenoid erosion with biconcavity of glenoid and subluxation of humeral head\n* Inability of humeral head to support the CAP surface replacement"}, 'identificationModule': {'nctId': 'NCT00477360', 'acronym': 'CAP', 'briefTitle': 'Humeral Resurfacing Hemiarthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Humeral Resurfacing Hemiarthroplasty. Phase 2: Prospective Cohort Study', 'orgStudyIdInfo': {'id': '15052007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'C.A.P', 'interventionNames': ['Device: Humeral surface replacement hemiarthroplasty (CAP)']}], 'interventions': [{'name': 'Humeral surface replacement hemiarthroplasty (CAP)', 'type': 'DEVICE', 'description': 'C.A.P hemiarthroplasty', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 1N4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary Sport Medicine Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Dr. Richard Boorman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}, {'name': 'Dr. Dianne Bryant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'DePuy International', 'class': 'INDUSTRY'}, {'name': 'Johnson & Johnson', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr. Richard Boorman', 'oldOrganization': 'University of Calgary'}}}}