Computer-Assisted Total Knee Replacement Kinematics: DePuy Sigma Posterior Cruciate Substituting Knee and the DePuy Sigma RP Rotating Platform Knee

Study Overview
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Brief Summary
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Primary Research Questions: Do patients with knee osteoarthritis (OA) who undergo total knee replacement with a Sigma rotating platform have better clinical outcomes at 2 years post surgery (i.e. quality of life, function, range of motion) than similar patients who undergo total knee arthroplasty (TKA) using the Sigma fixed bearing knee? Do patients with knee OA who undergo TKA with a Sigma rotating platform have different knee kinetics and kinematics as measured by gait analysis than similar patients who undergo TKA using the Sigma fixed bearing knee? Do patients with knee OA who undergo TKA with or without computer assistance have better clinical outcomes at two years following surgery (quality of life, function, range of motion)? Do patients with knee OA who undergo TKA with or without computer assistance have different knee kinematics and kinetics as measured by gait analysis?

Official Title
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An Investigation of Computer-Assisted Total Knee Replacement Kinematics on Patient Performance: An Examination of the DePuy P.F.C.® SigmaTM Posterior Cruciate Substituting Knee and the DePuy P.F.C.® Sigma RP Rotating Platform Knee Systems

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: DePuy P.F.C.® Sigma Rotating Platform Knee


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 45-75 years Undergoing primary total knee arthroplasty Clinically significant osteoarthritic degeneration Exclusion Criteria: Active articular infections Bilateral knee replacement (simultaneous) Previous joint infections Significant concurrent ipsilateral hip osteoarthritis Chronic pain syndrome requiring medications for control History of chemical addiction Significant spinal stenosis, significant symptomatic sciatica Patients who are unlikely to comply with, participate in, or return for follow-up visits as described in the protocol Osteomyelitis, septicemia or other infections that may spread to other areas of the body Highly communicable diseases, immuno-compromising conditions and/or conditions that may limit follow-up (eg. AIDS, active tuberculosis, venereal disease, active hepatitis, neoplastic disease) Decreased mental comprehension and literacy Prior high tibial osteotomy Prior patellectomy Rheumatoid arthritis Pregnancy

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>DePuy P.F.C.® SigmaTM Posterior Cruciate Substituting Knee | |
| Experimental: 2<br>Rotating Platform Knee | Device: DePuy P.F.C.® Sigma Rotating Platform Knee<br>* no details<br>* Other names: no other name;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait and radiographic parameters |  | 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee pain, function |  | 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arthroplasty, knee, computer-assist, gait, Total knee arthroplasty, knee prostheses