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
N/A
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
Researchers are comparing two types of knee implant designs, medial pivot and single radius, used in total knee replacement surgery for adults with degenerative joint disease. The study aims to evaluate which design may lead to better knee motion, improved clinical outcomes, and higher patient satisfaction. This research is a single center, cohort study involving 100 adult subjects who will receive one of the two implant systems. Participants will undergo primary total knee arthroplasty using either the MicroPort Medial Pivot Knee System or the Stryker Triathlon Tritanium Knee System. Follow-up visits are scheduled pre-operatively, at the time of surgery, and post-operatively at 6 weeks, 6 months, 12 months, 24 months, 36 months, and 60 months. These visits will track recovery and implant performance over time. During the study, participants will have clinical evaluations, patient-reported outcome assessments, and specialized gait laboratory analyses to measure knee mechanics, muscle strength, range of motion, and function. Researchers will monitor implant survivorship, complications, and changes in knee scores and patient quality of life. The study will last up to five years, including long-term follow-up visits to assess outcomes and safety.
CONDITIONS
Brief 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 between 18 and 75 years
- Willing to provide informed consent to participate in the research study
- Indicated for primary total knee arthroplasty using either the MicroPort Evolution Medial-Pivot Knee System or the Stryker Triathlon Tritanium Knee System
- No history of previous prosthetic replacement on the operative knee
- Currently able to walk and no condition affecting the opposite limb that would interfere with gait evaluations
- Willing and able to comply with the 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
- Any mental or neuromuscular disorder that increases risk of prosthesis instability or complications
- Being a prisoner
- Any condition that in the investigator's opinion may interfere with study evaluations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo total knee arthroplasty using one of two knee implant designs and receive immediate post-operative care.
1 operative visit (in-person)
Duration - Up to 60 months
Participants attend scheduled follow-up visits to monitor implant survivorship, assess complications, and evaluate recovery outcomes.
Follow-up visits at 6 weeks, 6 months, 12 months, 24 months, 36 months, and 60 months (in-person)
Trial Site Locations
Total: 1 location
1
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Actively Recruiting
Research Team
M
Martin Gesheff
N
Nirav Patel
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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