Status:
RECRUITING
Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty
Lead Sponsor:
LifeBridge Health
Collaborating Sponsors:
Rubin Institute for Advanced Orthopedics
MicroPort Orthopedics Inc.
Conditions:
Osteoarthritis, Knee
Knee Osteoarthritis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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...
Detailed Description
This is a single center, cohort study in 100 adult subjects undergoing primary total knee arthroplasty that will receive one of the two total knee device systems. Primary total knee replacement is an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04814082
Start Date
February 1 2021
End Date
July 1 2030
Last Update
January 22 2025
Active Locations (1)
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1
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215