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Sponsored by: |
Corin |
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Information provided by: | Corin |
ClinicalTrials.gov Identifier: | NCT00722007 |
The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis Avascular Necrosis Rheumatoid Arthritis |
Device: Cormet Hip Resurfacing |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Cormet Resurfacing Hip System Post PMA-Approval Study Post-Approval Study Group (New Enrollment) |
Estimated Enrollment: | 160 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
hip resurfacing
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Device: Cormet Hip Resurfacing
Cormet Hip Resurfacing implant
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This study tracks the performance of the Cormet Hip Resurfacing system in the post-approval environment to see if there are significant changes in device performance from the pre-market IDE setting as compared to the post-approval setting. Specifically this study will compare the proportion of subjects achieving a Month 24 composite clinical success (CCS) criterion and 24 month cumulative revision rate among the newly enrolled post-approval study subjects to the IDE subjects' performance on CCS as reported in the Pre-Market Application (PMA).
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yassaman Najmabadi, BS CRA | 813-977-4469 | yassaman.najmabadi@coringroup.com |
United States, District of Columbia | |
George Washington University | Recruiting |
Washington DC, District of Columbia, United States, 20006 | |
Contact: Lucy 202-466-5151 lucy@wosm.com | |
Principal Investigator: Anthony Unger, MD | |
United States, Texas | |
Memorial Bone & Joint | Recruiting |
Houston, Texas, United States, 77024 | |
Contact: Elizabeth 713-827-9316 ehernandez@mbjc.net | |
Principal Investigator: Stefan Kreuzer, MD |
Study Director: | Yassaman Najmabadi, BS CRA | Corin |
Responsible Party: | Corin USA ( Kathy Trier ) |
Study ID Numbers: | Cormet (P050016) New Enroll |
Study First Received: | July 23, 2008 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00722007 |
Health Authority: | United States: Institutional Review Board |
hip resurfacing osteoarthritis avascular necrosis rheumatoid arthritis |
Necrosis Autoimmune Diseases Musculoskeletal Diseases Osteonecrosis Osteoarthritis Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Bone Diseases |
Pathologic Processes Immune System Diseases |