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

Launched by LIFEBRIDGE HEALTH · Mar 22, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at two different types of knee implant designs used in total knee replacements for patients with knee osteoarthritis, a condition that causes pain and stiffness in the knee. The study aims to compare a "medial pivot" design, which is believed to help recreate more natural knee movement, to a "single radius" design. Researchers want to see which design leads to better outcomes, such as less pain and improved ability to move, by using various assessments, including feedback from patients and specialized gait analysis.

To participate in this study, individuals need to be between 18 and 75 years old and should be planning to have a total knee replacement with either the medial pivot or single radius implant. They should also be able to walk and not have certain medical conditions that could affect the results, like a very high body weight or specific knee issues. If you decide to join, you’ll need to attend follow-up visits to check your progress, and your experiences will help researchers understand which implant design works better for improving knee function and quality of life.

Gender

ALL

Eligibility criteria

• 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.