The purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.
The study will evaluate the clinical performance of cruciate ligament retaining or cruciate ligament substituting implants through a series of primary TKAs. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee implant or the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee implant and assignment will be randomized.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
399
Rotating Platform (RP) Cruciate Retaining Knee implant
Rotating Platform (RP) Cruciate Substituting Knee implant.
Unnamed facility
La Jolla, California, United States
West Coast Orthopaedic Specialists
Crystal River, Florida, United States
Unnamed facility
Melbourne, Florida, United States
Unnamed facility
Cleveland Heights, Ohio, United States
Knee Society scores
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.
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