Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLifeBridge Health

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

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

LifeBridge Health

Lead sponsor

Rubin Institute for Advanced Orthopedics

Collaborator

MicroPort Orthopedics Inc.

Collaborator