The purpose of this study is to evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.
This study will evaluate the clinical performance of rotating platform and fixed bearing knee implants. This will be done by obtaining a series of primary total knee replacements. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee System or the P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System and assignment is randomized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
99
Rotating Platform (RP) Cruciate Retaining Knee System
Fixed Cruciate Retaining Knee System
Unnamed facility
Billings, Montana, United States
Unnamed facility
Vancouver, Washington, United States
Knee Society Scores
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and \< 60 = poor.
Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Complications/Revisions
Time frame: On-going to end of study.
Medical Imaging
Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
SF-12 Patient Outcomes
Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.