Actively Recruiting
Comparison of Medial Pivot Polyethylene Versus Ultra-congruent Polyethylene in Total Knee Arthroplasty
Led by University Hospital, Clermont-Ferrand · Updated on 2025-01-17
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two types of polyethylene inserts used in total knee replacement surgery for patients with arthritis. The study focuses on the medial pivot polyethylene and ultra-congruent polyethylene, which serve as the interface between the metallic femoral and tibial components of the prosthetic knee. These inserts aim to provide stability and mimic natural knee movements to improve patient quality of life after surgery. Participants will receive a total knee replacement using either the medial pivot polyethylene or the ultra-congruent polyethylene. Both types are designed to replace knee ligaments and support natural knee motion, but they differ in design. The study randomly assigns participants to one of these two groups to compare their outcomes. During the study, participants will be assessed before surgery, at 45 days, and at 12 months. Evaluations include the forgotten joint score, which measures how natural the knee feels, as well as knee mobility, pain levels, and knee function scores. Researchers will also review X-rays to check alignment and complications. The study aims to gather detailed information on knee performance and patient satisfaction over one year after surgery.
CONDITIONS
Brief Title
Comparison of Pivotal Medial Polyethylene Versus Ultra-congruent in Total Knee Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects 18 to 90 years of age eligible for a primary total knee replacement for gonarthrosis
- Competent subjects able to give informed consent to participate in the research
- Affiliation to the social security system
You will not qualify if you...
- History of infection in the knee to be replaced
- Knee deformity greater than 15 degrees
- Any surgical or anesthetic contraindication or condition incompatible with the research
- Any contraindication listed in the medical device instructions for use
- Pregnant or breastfeeding women
- Recent infection of the surgical site
- Adults under legal protection or unable to express consent
- Subjects who refuse to participate
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 - Up to 1 day
Participants undergo total knee arthroplasty using either medial pivot or ultra-congruent polyethylene implant.
1 surgery visit
Duration - 12 months
Participants are monitored for recovery, pain, knee joint mobility, and radiological complications after surgery.
3 visits: Day 45, Month 12, and assessments one day before surgery (Day -1)
Trial Site Locations
Total: 1 location
1
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Actively Recruiting
Research Team
L
Lise Laclautre
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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