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Sponsors and Collaborators: |
Biomet, Inc. Knowledge Center for Orthopedic Surgery, St. Anna Hospital, Geldrop, Netherlands |
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Information provided by: | Biomet, Inc. |
ClinicalTrials.gov Identifier: | NCT00603395 |
This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.
Condition | Intervention |
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Arthritis Avascular Necrosis |
Device: ReCap Total Hip Resurfacing System |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Prospective Clinical Study On A Total Hip Resurfacing System |
Estimated Enrollment: | 300 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | September 2017 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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ReCap
ReCap Total Hip Resurfacing System
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Device: ReCap Total Hip Resurfacing System
This is a hip resurfacing system.
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
intended for skeletally mature individuals undergoing primary surgery as a result of hip degenerative joint disease, or any composite diagnoses, including:
Contact: Walter van der Weegen | 06-34282788 | w.vander.weegen@st-anna.nl |
Netherlands | |
Knowledge Center for Orthopedic Surgery, St. Anna hospital | Recruiting |
Geldrop, Netherlands | |
Contact: Walter van der Weegen 06-34282788 w.vander.weegen@st-anna.nl |
Principal Investigator: | H J Hoekstra, MD | St. Anna hospital, Geldrop |
Principal Investigator: | T Sybesma, PhD | St. Anna hospital, Geldrop |
Responsible Party: | Biomet Orthopedics, Inc. ( Tracy Johnson, Director of Clinical and Regulatory Affairs ) |
Study ID Numbers: | EU-6 |
Study First Received: | December 23, 2007 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00603395 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Necrosis Musculoskeletal Diseases Osteonecrosis |
Joint Diseases Arthritis Bone Diseases |
Pathologic Processes |