Actively Recruiting
Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty
Led by LifeBridge Health · Updated on 2025-01-22
100
Participants Needed
1
Research Sites
491 weeks
Total Duration
On this page
Sponsors
L
LifeBridge Health
Lead Sponsor
R
Rubin Institute for Advanced Orthopedics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant female aged 18 to 75 years
- Willing to provide informed consent to participate
- Indicated for primary total knee arthroplasty with either MicroPort Evolution Medial-Pivot Knee System or Stryker Triathlon Tritanium Knee System
- No previous prosthetic replacement on the operative knee
- Currently able to walk without conditions on the other leg interfering with gait evaluation
- Willing and able to comply with study schedule and attend all follow-up visits
You will not qualify if you...
- Body Mass Index (BMI) greater than 40
- Diagnosis of avascular necrosis or inflammatory arthritis
- Mental or neuromuscular disorders risking prosthesis instability or complications
- Prisoner status
- Any condition judged by the investigator to interfere with study evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Actively Recruiting
Research Team
M
Martin Gesheff
CONTACT
N
Nirav Patel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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