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Sponsored by: |
Biomet Orthopedics, LLC |
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Information provided by: | Biomet, Inc. |
ClinicalTrials.gov Identifier: | NCT00588783 |
The purpose of this study is to compare the clinical outcomes of using an I-beam or cruciate tibial component in total knee replacement.
Condition | Intervention |
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Degenerative Arthritis Osteoarthritis Rheumatoid Arthritis Knee Arthritis |
Device: I-beam design Device: Cruciate design |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Enrollment: | 100 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | September 2017 |
Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1 |
Device: I-beam design
This group will utilize tibial components with an I-beam design for total knee replacement.
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2 |
Device: Cruciate design
This group will utilize tibial components with cruciate designs for total knee replacement.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
The study population will include patients requiring total knee replacement.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Biomet Orthopedics, LLC ( Kenneth J. Beres, MD, Director of Clinical Research ) |
Study ID Numbers: | 104-U-013 |
Study First Received: | December 21, 2007 |
Last Updated: | July 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00588783 History of Changes |
Health Authority: | United States: Institutional Review Board |
Autoimmune Diseases Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |