Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty
Eligible age
18–75 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: LifeBridge Health
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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 recruiting
Baltimore
Source: ClinicalTrials.gov · NCT04814082 · last updated 2025-01-22