Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot
Patients with degenerative joint disease can effectively be treated with a primary total knee replacement to reduce pain and improve function in their daily lives. Theoretically, achievement of normal knee motion using a medial pivot design in total knee replacements can be recreated in comparison to single radius designs, which could lead to an improvement in post-surgical outcomes and satisfaction with the procedure. The aim of this study is to compare two types of implant designs (medial pivot and single radius) in a total knee replacement using clinical outcomes, patient reported outcomes, and overall function assessed by a specialized gait laboratory.
• Subject is male or non-pregnant female aged between 18 and 75 years of age.
• Subject is willing to provide informed consent to participate in the research study.
• Subject is indicated for a primary total knee arthroplasty (TKA) based on the approved labeling of knee implant, either a medial pivot or single radius design, specifically: MicroPort Evolution Medial-Pivot Knee System, Cruciate Retaining (CS) or Stryker Triathlon Tritanium (CS)
• Subject does not have a history of previous prosthetic replacement device on the operative knee.
• Subject is currently ambulating and does not have a condition on the contralateral limb in the opinion of the investigator that would interfere with the gait laboratory evaluations.
• Subject is willing and able to comply with the schedule of events for the study and is available to return to the clinic for all required follow-up visits.