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

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

Plain Language Summary

Simplified for easier understanding

This study compares two different designs of total knee replacement (TKA) implants: the Medial Pivot design (MicroPort Evolution) and the Single Radius design (Stryker Triathlon). Both are approved and commonly used. The researchers want to find out if one design leads to better walking patterns, movement, and function after surgery compared to the other. Participants will have their gait (walking pattern) analyzed in a laboratory before and after surgery, and will return for scheduled follow-up visits. This study does not involve any experimental treatments — both implants are already approved for clinical use. You may be eligible if: - You are between 18 and 75 years old - You are scheduled for your first total knee replacement on that knee (no prior prosthetic on that knee) - You are currently able to walk and do not have a condition on the other leg that would interfere with gait testing - Your BMI is 40 or below - You are willing to attend all follow-up visits You may NOT be eligible if: - You are under 18 or over 75 years old - You have had a previous knee replacement on the operative knee - You have avascular necrosis or inflammatory arthritis - You have a BMI greater than 40 - You have a mental or neuromuscular disorder that would affect implant stability or recovery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

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NCT04814082


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