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| Sponsor: | Biomet Orthopedics, LLC |
|---|---|
| Information provided by: | Biomet, Inc. |
| ClinicalTrials.gov Identifier: | NCT00698503 |
Purpose
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the M2a- 38™ Hip System
| Condition |
|---|
|
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 |
|---|
| M2a- 38™ Hip System |
Eligibility| 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:
Contacts and Locations
More Information
| Responsible Party: | Biomet Orthopedics, LLC ( Kenneth Beres, MD. Director Clinical Research ) |
| Study ID Numbers: | 12380-6 |
| Study First Received: | June 13, 2008 |
| Last Updated: | June 26, 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 Pathologic Processes Musculoskeletal Diseases Osteonecrosis Osteoarthritis |
Arthritis Joint Diseases Rheumatic Diseases Bone Diseases |