The purpose of this study is to test for significant differences in functional outcomes obtained by using a NexGen LPS versus a NexGen LPS-Flex knee implant. Specifically, it is predicted that an increase in postoperative range of motion will be experienced by patients treated with the NexGen LPS-Flex knee implant.
This study will compare the clinical results of the NexGen LPS femoral component with the higher flexion potential of the NexGen LPS-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is postoperative 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
331
NexGen LPS-Flex Fixed Bearing femoral component
NexGen Legacy Posterior Stabilized femoral component
University of Alabama at Birmingham
Birmingham, Alabama, United States
VA Medical Center
Decatur, Georgia, United States
Postoperative Range of Motion (ROM)
Postoperative ROM was calculated by taking the measurement of patient flexion minus the measurement of patients' extension.
Time frame: 6 Weeks to 2 Years Post-op, based on on the intervals listed
Return to Function (RtF) Via Knee Society 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 established follows: 80-100 =Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor.
Time frame: 6 Weeks to 2 Years Post-op, based on on the intervals listed
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Southern Illinois University School of Medicine
Springfield, Illinois, United States
Joint Replacement Surgeons of Indiana
Indianapolis, Indiana, United States
The Center for Hip and Knee Surgery
Mooresville, Indiana, United States
OrthoCarolina Research Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
VSAS Orthopaedics
Allentown, Pennsylvania, United States
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, United States
Piedmont Orthopaedic Associates
Greenville, South Carolina, United States
...and 5 more locations