The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.
The study will evaluate the clinical performance of rotating platform and fixed bearing cruciate ligament substituting implants by obtaining a series of primary TKAS. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System or P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System and assignment is randomized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
149
Rotating Platform (RP) Cruciate Substituting Knee System
Fixed Cruciate Substituting Knee System
Unnamed facility
Greensboro, North Carolina, United States
Unnamed facility
Austin, Texas, United States
Unnamed facility
Lakewood, Washington, United States
Knee Society Score
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
Time frame: On-going to end of study
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.