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Sponsored by: |
Biomet Orthopedics, LLC |
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Information provided by: | Biomet, Inc. |
ClinicalTrials.gov Identifier: | NCT00588861 |
The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement.
Condition | Intervention |
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Degenerative Joint (Hip) Disease Arthritis of the Hip Joint |
Device: Answer® hip stem |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment |
Official Title: | Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Acetabular Shell Using Simplex® or Palacos® Bone Cement |
Enrollment: | 400 |
Study Start Date: | September 2002 |
Estimated Study Completion Date: | September 2016 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Device: Answer® hip stem
Total hip replacement using Palacos® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.
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2: Active Comparator |
Device: Answer® hip stem
Total hip replacement using Simplex® bone cement, the Answer® hip stem and the Ranawat/Burnstein® acetabular shell.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Biomet Orthopedics, LLC ( Kenneth J. Beres, Director of Clinical Research ) |
Study ID Numbers: | 101-U-011 |
Study First Received: | December 19, 2007 |
Last Updated: | July 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00588861 History of Changes |
Health Authority: | United States: Institutional Review Board |
Musculoskeletal Diseases Joint Diseases Arthritis |
Musculoskeletal Diseases Joint Diseases Arthritis |