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Sponsored by: |
DePuy Orthopaedics |
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Information provided by: | DePuy Orthopaedics |
ClinicalTrials.gov Identifier: | NCT00306930 |
This study is a clinical evaluation of an acetabular cup system after total hip replacement using patient examinations and questionnaires.
Condition | Intervention | Phase |
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Osteoarthritis Rheumatoid Arthritis Arthritis Avascular Necrosis Acute Fracture |
Device: Acetabular cup |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Multi-Center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty |
Enrollment: | 1500 |
Study Start Date: | October 2000 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A
Acetabular cup replacement with total hip arthroplasty
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Device: Acetabular cup
Acetabular cup replacement
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The primary objective of this investigation is to evaluate survivorship at five years of the Pinnacle™ acetabular cup system in primary total hip arthroplasty.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Indiana | |
DePuy Orthopaedics | |
Warsaw, Indiana, United States, 46581 |
Principal Investigator: | Russell G Tigges, MD | Saint Francis Memorial Hospital |
Principal Investigator: | John R Ayres, MD | Coastal Orthopedics and Sports Medicine |
Responsible Party: | DePuy Orthopaedics, Inc. ( Jennifer C. Hoag, MS ) |
Study ID Numbers: | PIN |
Study First Received: | March 23, 2006 |
Last Updated: | July 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00306930 |
Health Authority: | United States: Institutional Review Board |
Total Hip Replacement post-traumatic arthritis |
Necrosis Autoimmune Diseases Musculoskeletal Diseases Osteonecrosis Osteoarthritis Joint Diseases |
Arthritis Fractures, Bone Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Bone Diseases |
Pathologic Processes Immune System Diseases |