Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-28 @ 11:44 AM
Study NCT ID:
NCT00698503
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 M2a- 38™ Hip System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010020', 'term': 'Osteonecrosis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'whyStopped': 'due to low follow up', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2008-12', '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': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Harris Hip Score', 'timeFrame': '12 weeks, 1 year, 3 years, 5 years'}], 'secondaryOutcomes': [{'measure': 'Incidence of revisions and removals', 'timeFrame': 'Any time'}]}, 'conditionsModule': {'keywords': ['Metal on Metal', 'Total Hip Arthroplasty', 'Total Hip Replacement'], 'conditions': ['Non-inflammatory Degenerative Joint Disease', 'Osteoarthritis', 'Avascular Necrosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a- 38™ Hip System'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that have already made the decision to undergo Total Hip Replacement and will receive the M2a- 38™ Hip System', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having primary cemented or cementless total hip replacement for non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnosis of osteoarthritis, avascular necrosis, traumatic arthritis, subcapital fracture, legg perthes, slipped capital epiphysis, fracture of the pelvis, diastrophic variant.\n* Patients with full skeletal maturity\n* Patients undergoing unilateral total hip arthroplasty or bilateral total hip arthroplasty, either staged or simultaneously\n* Patients of all races and gender\n* Patients who are able to follow postoperative care instructions\n* Patients who are able and willing to return for follow-up evaluations\n* Patients have preoperative total Harris Hip Score less than 70 with at least moderate pain.\n\nExclusion Criteria:\n\n* Patients diagnosed with inflammatory degenerative arthritis (IDJD) to include the following composite diagnoses: rheumatoid arthritis, systemic lupus erythematous, pigmented villonodular synovitis, juvenile rheumatoid arthritis and other arthritic processes of inflammatory or autoimmune etiology.\n* Patients less than 18 years.\n* Patients with the presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.)in the hip joint to be operated.\n* Patients with previous Girdlestone procedures.\n* Patients with above the knee amputation of the contralateral and/or ipsilateral leg.\n* Patients with osteoporosis, or marked bone loss which would preclude proper fixation of the prosthesis.\n* Patients who are pregnant.\n* Patients with an active or suspected infection in or around the hip.\n* Patients with Parkinson\'s disease.\n* Patients with vascular insufficiency, muscular atrophy, or neuromuscular disease in the affected limb.\n* Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue which would preclude stability of the prosthesis.\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 total hip replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.\n* Patients with previous hip surgery or conditions that may interfere with the total hip replacement\'s survival or outcome, e.g., Paget\'s disease, Charcot\'s disease, severe osteoporosis compromising bone stock (Dorr type C bone).\n* Patients who qualify for inclusion in the study, but refuse consent to participate in the study.\n* Patients with a "fused" hip.\n* Patients who have had a total hip arthroplasty on the contralateral hip within the last year.'}, 'identificationModule': {'nctId': 'NCT00698503', 'briefTitle': 'A Clinical Investigation of the M2a- 38™ Hip System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'M2a- 38™ Hip System Prospective Data Collection', 'orgStudyIdInfo': {'id': '12380-6'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'M2a- 38™ Hip System'}]}, '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'}}}}