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Sponsored by: |
Zimmer, Inc. |
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Information provided by: | Zimmer, Inc. |
ClinicalTrials.gov Identifier: | NCT00761956 |
The purpose of this study is to test for significant differences in functional outcomes, specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a NexGen CR-Flex knee implant. Specifically, it is predicted that an increase in post-operative range of motion will be experienced by patients treated with the NexGen CR-Flex knee implant.
Condition | Intervention |
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Total Knee Arthroplasty Osteoarthritis |
Device: NexGen CR-Flex Fixed Bearing Knee Device: NexGen CR Knee |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective Randomized Multicenter Study of NexGen CR-Flex Knee |
Estimated Enrollment: | 400 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
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Device: NexGen CR-Flex Fixed Bearing Knee
NexGen CR-Flex Fixed Bearing femoral component
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2: Active Comparator
Study arm will consist of patients that are treated with the NexGen CR Knee.
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Device: NexGen CR Knee
NexGen Complete Knee Solution Cruciate Retaining femoral component
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This study will compare the clinical results of the NexGen CR femoral component with the higher flexion potential of the NexGen CR-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is post-operative range of motion achieved with the two devices, which are implanted with slightly different surgical techniques in patients who may also be subjected to different rehabilitation programs depending on the device they are assigned.
Ages Eligible for Study: | 21 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Delaware | |
Dickinson Medical Group, LLC | |
Milford, Delaware, United States, 19963 | |
United States, Illinois | |
University of Chicago Hospital | |
Chicago, Illinois, United States, 60637 | |
Rockford Orthopedic Associates | |
Rockford, Illinois, United States, 61107 | |
United States, Massachusetts | |
University of Massachusetts Memorial Medical Center | |
Worcester, Massachusetts, United States, 01605 | |
United States, Michigan | |
Orthopaedic Associates of Grand Rapids, PC | |
Grand Rapids, Michigan, United States, 49525 | |
United States, North Carolina | |
Pinehurst Surgical Center | |
Pinehurst, North Carolina, United States, 28374 | |
United States, Oregon | |
Slocum Orthopedics, PC | |
Eugene, Oregon, United States, 97401 | |
United States, Pennsylvania | |
The Orthopedic Group | |
Clairton, Pennsylvania, United States, 15025 |
Responsible Party: | Zimmer, Inc ( Andrew Warner, Clinical Research Specialist ) |
Study ID Numbers: | 04-300 |
Study First Received: | September 26, 2008 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00761956 |
Health Authority: | United States: Institutional Review Board |
Total Knee Arthroplasty Osteoarthritis Knee |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |