RecruitingNot ApplicableNCT04814082

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

Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot

Sponsor

LifeBridge Health

Enrollment

100 participants

Start Date

Feb 1, 2021

Study Type

INTERVENTIONAL

Conditions

Knee Osteoarthritis Osteoarthritis, Knee Knee Pain Chronic Knee Disease Osteoarthritis Knees Both Osteoarthritis Knee Left Osteoarthritis Knee Right Arthropathy of Knee Joint

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

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.

Exclusion Criteria5

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
Subject has any condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.