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Sponsored by: |
Biomet Orthopedics, LLC |
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Information provided by: | Biomet, Inc. |
ClinicalTrials.gov Identifier: | NCT00698854 |
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System.
Condition |
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Osteoarthritis Traumatic Arthritis Rheumatoid Arthritis |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A Prospective, Non-Controlled, Clinical Investigation of the Vanguard™ Complete Knee System |
Estimated Enrollment: | 600 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | December 2013 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Vanguard™ Complete Knee System
Vanguard™ Complete Knee System
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This is a 5-year prospective observational data collection on the Vanguard Total Knee system. Patients are asked to come in for a preop, operative, impo, 6 Month, 1 Year, 3 Year, & 5 Year visit to check on the function, range of motion, and radiographic assessment of their total knee device.
The Vanguard Knee is an FDA cleared device, and has been on the market since 2004.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients in need of relief from painful or disabling joint disease
Inclusion criteria:
Patient selection factors to be considered include:
Exclusion criteria:
Absolute contraindications include:
Relative contraindications include:
United States, Iowa | |
Physicians Clinic of Iowa Orthopedics | |
Cedar Rapids, Iowa, United States, 52403 | |
United States, Maryland | |
The Orthopaedic Center | |
Rockville, Maryland, United States, 20850 | |
United States, New York | |
Orthopaedic Associates of Rochester | |
Rochester, New York, United States, 14626 | |
United States, Texas | |
Texas Orthopedic Specialists | |
Grapevine, Texas, United States, 76015 | |
United States, Virginia | |
Orthopedic Associates | |
Fishersville, Virginia, United States, 22939 | |
United States, Washington | |
Spokane Orthopedics | |
Spokane, Washington, United States, 99207 | |
United States, Wisconsin | |
Othopaedic & Sports Medicine Clinic of Monroe | |
Monroe, Wisconsin, United States, 53566 |
Study Director: | Kenneth J Beres, MD | Clinical Research, Biomet Orthopedics, LLC |
Responsible Party: | Biomet Orthopedics, LLC ( Kenneth Beres, MD Director Clinical Research ) |
Study ID Numbers: | Biomet 13594-53 |
Study First Received: | June 13, 2008 |
Last Updated: | April 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00698854 History of Changes |
Health Authority: | United States: Institutional Review Board |
Total Knee Arthroplasty Total Knee Replacement Knee Arthritis |
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 |