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 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
Parallel
MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)
DeviceMedial Pivot Knee System
Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)
DeviceSingle Radius Design Total Knee System
Change in Knee Mechanics
Knee flexion/extension, varus/valgus, and internal/external rotation will be measured (in degrees) and analyzed using the KneeKG system during incline and decline walking.
Change in Anterior/Posterior Knee Translation
This parameter will be measured (in mm) and analyzed using the KneeKG system during incline and decline walking.
Change in Initial Peak Loading Force
This parameter will be measured (in N) and analyzed using the KneeKG system during normal walking.
Change in Active and Passive Range of Motion
Active and passive range of motion will be measured (in degrees) using a goniometer.
Implant Survivorship
Radiographic assessment using AP and lateral knee X-rays to analyze implant position, radiolucencies, fracture, and osteolysis.
Post-surgical Complications
All complications related to the procedure will be documented.
Evidence of Osteolysis
X-rays will be evaluated to look for presence of a radiolucent area, especially \> 2mm, around implant or cement with sclerotic border.
Change in Knee Society Score (KSS) Short Form
25 question items assessing symptoms, patient satisfaction, patient expectation, and their level of functional activity of their knee. Scores range from 0-100 with higher scores representing better outcomes.
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LifeBridge Health
Lead sponsor
Rubin Institute for Advanced Orthopedics
Collaborator
MicroPort Orthopedics Inc.
Collaborator
