NCT00375856

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Queen's University · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Primary Research Questions: 1. 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? 2. 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? 3. 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)? 4. Do patients with knee OA who undergo TKA with or without computer assistance have different knee kinematics and kinetics as measured by gait analysis?

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	DePuy P.F.C.® Sigma Rotating Platform Knee	no details

Timeline

• Start date: 2006-10-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2006-09-13
• Last updated: 2016-09-27

Locations

3 sites across 1 country: Canada