Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot
LifeBridge Health
Summary
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.
Description
This is a single center, cohort study in 100 adult subjects undergoing primary total knee arthroplasty that will receive one of the two total knee device systems. Primary total knee replacement is an effective treatment for relieving pain and improving function for patients with degenerative joint disease. Recently, design of knee implants in a total knee replacement have received increased interest, particularly the medial pivot designs. Single-radius implants are designed to minimize instability throughout the functional range of movement. Medial pivot total knee designs theoretically recre…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DeviceMicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)
Medial Pivot Knee System
- DeviceStryker Triathlon Tritanium Knee System (Condylar Stabilizing)
Single Radius Design Total Knee System
Location
- Sinai Hospital of BaltimoreBaltimore, Maryland