Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-05 @ 9:16 AM
Study NCT ID:
NCT00698750
Status:
TERMINATED
Last Update Posted:
2017-06-21
First Post:
2008-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Investigation of the Copeland™ Humeral Resurfacing Head
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D006810', 'term': 'Humeral Fractures'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'whyStopped': 'Sponsor terminated study early due to limited enrollment and follow-up.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-19', 'studyFirstSubmitDate': '2008-06-13', 'studyFirstSubmitQcDate': '2008-06-13', 'lastUpdatePostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ASES Assessment', 'timeFrame': '6 months, 1 year, 2 years, 3 years, 4 years, 5 years'}, {'measure': 'X-rays', 'timeFrame': '6 months, 1 year, 2 years, 3 years, 4 years, 5 years'}], 'secondaryOutcomes': [{'measure': 'Incidence of revision or removals', 'timeFrame': 'Any time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fractured Humeral Head', 'Traumatic Arthritis', 'Resurfacing Shoulder', 'Shoulder Replacement', 'Shoulder Arthritis'], 'conditions': ['Osteoarthritis', 'Rheumatoid Arthritis', 'Avascular Necrosis', 'Humeral Fractures']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to perform a five-year, prospective evaluation of the Copeland™ Humeral Resurfacing Head Prosthesis for outcome and durability. Relief of pain and restoration of function will determine long-term clinical outcome while durability will be measured by the absence of revisions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients requiring humeral resurfacing.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.\n* Rheumatoid arthritis\n* Correction of functional deformity\n* Reconstructable Rotator Cuff\n* Treatment of acute fracture of the humeral head\n* Traumatic arthritis\n\nExclusion Criteria:\n\n* Patients less than 18 years.\n* Patients with rapid joint destruction, osteomalacia, osteoporosis, or marked bone loss, which would preclude proper fixation of the prosthesis.\n* Patients with marked bone loss apparent on roentgenogram.\n* Metabolic disorders, which may impair bone formation.\n* Patients who are pregnant.\n* Patients with an active or suspected infection in or around the shoulder or distant foci of infections, which may spread to the implant site.\n* Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue, which would prelude stability of the prosthesis.\n* Patients who have had revision procedures where other devices or treatments have failed.\n* Patients with a highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, neoplastic disease, etc).\n* Patients unwilling or unable to comply with a rehabilitation program for a cemented or cementless partial or total shoulder replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.\n* Patients with previous shoulder surgery or conditions that may interfere with the partial or total shoulder replacement's survival or outcome.\n* Patients who qualify for inclusion in the study, but refuse consent to participate in the study.\n* Patients who have had a partial or total shoulder arthroplasty on the contralateral shoulder within the last year."}, 'identificationModule': {'nctId': 'NCT00698750', 'briefTitle': 'A Clinical Investigation of the Copeland™ Humeral Resurfacing Head', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Prospective, Non-controlled, Clinical Investigation of the Copeland™ Humeral Resurfacing Head', 'orgStudyIdInfo': {'id': 'Biomet 12381-30'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Copeland™ Humeral Resurfacing Head', 'description': 'Copeland™ Humeral Resurfacing Head'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kenneth J Beres, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director, Clinical Research, Biomet Orthopedics, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biomet Orthopedics, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}