Comparison of two knee implant designs for total knee replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the clinical outcomes and patient satisfaction between two types of knee implant designs used in total knee arthroplasty: the medial pivot design and the single radius design. It involves 100 adult participants who will undergo primary total knee replacement and will be assessed through various methods, including clinical evaluations and specialized gait analysis. The study aims to determine which implant design may lead to better functional outcomes and overall satisfaction post-surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sinai Hospital of Baltimore
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: James Nace, MD — LifeBridge Health
• Study coordinator: Martin Gesheff
• Email: mgesheff@lifebridgehealth.org
• Phone: 410-601-9467

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.