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

RecruitingNAAges 18 Years - 75 YearsAllLifeBridge Health
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 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 Criteria: * 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.
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What it tests

  • MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)
  • Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)
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Where

1 site
Sinai Hospital of Baltimore
Baltimore, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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