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Sponsored by: |
DePuy Orthopaedics |
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Information provided by: | DePuy Orthopaedics |
ClinicalTrials.gov Identifier: | NCT00306917 |
Prospective, randomized study of Summit Porocoat versus Summit DuoFix HA in total hip arthroplasty
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis Rheumatoid Arthritis Post-Traumatic Arthritis Avascular Necrosis Acute Fracture |
Device: non-coated femoral hip stem Device: coated femoral hip stem |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Randomized Study of Summit™ Porocoat® Versus Summit™ DuoFix™ HA in Cementless Total Hip Arthroplasty |
Enrollment: | 400 |
Study Start Date: | November 2002 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
DuoFix HA
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Device: non-coated femoral hip stem
total hip replacement
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2: Active Comparator
Porocoat porous coated
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Device: coated femoral hip stem
total hip replacement
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Hydroxyapatite (HA) is a bioactive ceramic that resembles the natural inorganic mineral content of bone, and as such is a highly osteoconductive material. The purpose of this study is to compare an HA coated and uncoated prosthesis.
Ages Eligible for Study: | up to 75 Years |
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: | David A Fisher, MD | Orthopaedics Indianapolis |
Principal Investigator: | J W Mesko, MD | Michigan Orthopaedics Center |
Principal Investigator: | Paul Perona, MD | St Margaret's Hospital Family Orthopaedics |
Principal Investigator: | Stephan B Lowe, MD | Orthopaedic Specialists of the Carolinas |
Principal Investigator: | Donald L Pomeroy, MD | Pomeroy & Reddy |
Principal Investigator: | Nithin Reddy, MD | Pomeroy & Reddy |
Responsible Party: | DePuy Orthopaedics, Inc. ( Barry Sisson, MBA ) |
Study ID Numbers: | SPD |
Study First Received: | March 23, 2006 |
Last Updated: | July 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00306917 |
Health Authority: | United States: Food and Drug Administration |
Total Hip Replacement |
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 |