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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
189
NexGen CR-Flex Fixed Bearing femoral component
NexGen Complete Knee Solution Cruciate Retaining femoral component
Dickinson Medical Group, LLC
Milford, Delaware, United States
University of Chicago Hospital
Chicago, Illinois, United States
Rockford Orthopedic Associates
Rockford, Illinois, United States
University of Massachusetts Memorial Medical Center
Postoperative Range of Motion (ROM)
The subject will have the operative joint's range of motion/movement assessed through a series of exercises and bends. The assessor will measure how far the joint bends/moves in each direction by degrees. The measurements are taken at each visit interval and recorded.
Time frame: 24 Months
Return to Function (RtF) Via Knee Scoiety Score (Modified)
Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals. Grading for the Knee Society Score is based on a scale from 0-100 and results are estabalished follows: 80-100 = Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor.
Time frame: 24 Months
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Worcester, Massachusetts, United States
Orthopaedic Associates of Grand Rapids, PC
Grand Rapids, Michigan, United States
Pinehurst Surgical Center
Pinehurst, North Carolina, United States
Slocum Orthopedics, PC
Eugene, Oregon, United States
The Orthopedic Group
Clairton, Pennsylvania, United States