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Sponsored by: |
Biomet Orthopedics, LLC |
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Information provided by: | Biomet, Inc. |
ClinicalTrials.gov Identifier: | NCT00698867 |
The purpose of this study is to perform a five-year, multi-center prospective evaluation of the Discovery™ Elbow System 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.
Condition |
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Osteoarthritis Rheumatoid Arthritis Avascular Necrosis Humeral Fractures |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A Prospective, Non-Controlled, Clinical Investigation of the Discovery™ Elbow System |
Estimated Enrollment: | 400 |
Study Start Date: | June 2002 |
Estimated Study Completion Date: | June 2015 |
Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Discovery™ Elbow
Discovery™ Elbow
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients in need of relief from painful or disabling Joint Disease.
Inclusion Criteria:
Patient Selection factors to be considered include:
Exclusion Criteria:
Responsible Party: | Biomet Orthopedics, LLC ( Kenneth Beres, MD. Director Clinical Research ) |
Study ID Numbers: | Biomet 12381-8 |
Study First Received: | June 13, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00698867 History of Changes |
Health Authority: | United States: Institutional Review Board |
Total Elbow Arthroplasty Total Elbow Replacement Osteoarthritis Elbow arthritis |
Autoimmune Diseases Osteonecrosis Osteoarthritis Joint Diseases Fractures, Bone Wounds and Injuries Arthritis, Rheumatoid Disorders of Environmental Origin |
Humeral Fractures Rheumatic Diseases Bone Diseases Arm Injuries Necrosis Musculoskeletal Diseases Arthritis Connective Tissue Diseases |
Autoimmune Diseases Osteonecrosis Immune System Diseases Osteoarthritis Joint Diseases Fractures, Bone Wounds and Injuries Arthritis, Rheumatoid Disorders of Environmental Origin |
Humeral Fractures Rheumatic Diseases Bone Diseases Arm Injuries Necrosis Pathologic Processes Musculoskeletal Diseases Arthritis Connective Tissue Diseases |