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Sponsored by: |
Biomet Orthopedics, LLC |
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Information provided by: | Biomet, Inc. |
ClinicalTrials.gov Identifier: | NCT00698503 |
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a- 38™ Hip System
Condition |
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Non-Inflammatory Degenerative Joint Disease Osteoarthritis Avascular Necrosis |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | M2a- 38™ Hip System Prospective Data Collection |
Enrollment: | 190 |
Study Start Date: | January 2002 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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M2a- 38™ Hip System |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients that have already made the decision to undergo Total Hip Replacement and will receive the M2a- 38™ Hip System
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Biomet Orthopedics, LLC ( Kenneth Beres, MD. Director Clinical Research ) |
Study ID Numbers: | 12380-6 |
Study First Received: | June 13, 2008 |
Last Updated: | March 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00698503 History of Changes |
Health Authority: | United States: Institutional Review Board |
Metal on Metal Total Hip Arthroplasty Total Hip Replacement |
Necrosis Musculoskeletal Diseases Osteonecrosis Osteoarthritis |
Arthritis Joint Diseases Rheumatic Diseases Bone Diseases |
Necrosis Pathologic Processes Musculoskeletal Diseases Osteonecrosis Osteoarthritis |
Arthritis Joint Diseases Rheumatic Diseases Bone Diseases |