Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius D… (NCT04814082) | Clinical Trial Compass
RecruitingNot Applicable
Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty
United States100 participantsStarted 2021-02-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.