About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Subject has a Body Mass Index (BMI) >40
Subject has a diagnosis of avascular necrosis or inflammatory arthritis.
Subject has any mental or neuromuscular disorder that would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
Subject is a prisoner
Trial design
Treatments tested in this trial
- MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)
- Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)
Treatment groups
Sponsors and collaborators
LifeBridge Health
Lead sponsor
Rubin Institute for Advanced Orthopedics
Collaborator
MicroPort Orthopedics Inc.
Collaborator