Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID06676189

Comparison of Medial Pivot Versus Ultra-Congruent Polyethylene Inserts in Total Knee Replacement Surgery

Led by University Hospital, Clermont-Ferrand · Updated on 2025-01-17

90

Participants Needed

1

Research Sites

142 weeks

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: medial pivot polyethylene and ultra-congruent polyethylene. These inserts are part of the prosthetic device designed to replace the knee joint in patients with arthritis. The study aims to evaluate which type better meets patient expectations for pain relief and knee movement after surgery, focusing on the quality of life improvements. Both types of polyethylene aim to provide a stable and lasting contact surface between the metallic components of the knee implant, mimicking natural knee movement. The study involves two groups of participants who will receive total knee arthroplasty using either the medial pivot polyethylene or the ultra-congruent polyethylene insert. These inserts serve as the interface between the metallic femoral unit and the tibial baseplate of the knee prosthesis. The medial pivot system is designed to closely replicate anatomical knee kinematics with a rotational movement similar to a ball and socket. The study compares these two types of inserts through a randomized design, which has not been done before. Participants will be assessed using the forgotten joint score (FJS12) at 45 days and again at 12 months after surgery. This score measures how much patients are aware of their artificial knee during daily activities, reflecting comfort and function. Throughout the study, participants will undergo evaluations to monitor their knee function and recovery. The total participation age range is from 18 to 90 years, and the study tracks outcomes related to pain, movement, and overall knee performance following the replacement surgery.

CONDITIONS

Official Title

Comparison of Pivotal Medial Polyethylene Versus Ultra-congruent in Total Knee Arthroplasty

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Infection history of the knee to be replaced
  • Deformity greater than 15 degrees
  • Any surgical and/or anesthetic contraindication, or any condition deemed by the investigator to be incompatible with the research
  • Any contraindication mentioned in the instructions for use of the medical device
  • Pregnant or breastfeeding women
  • Recent infection history of the surgical site
  • Adults subject to a legal protection measure or unable to express consent
  • Subjects who refuse to participate

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Actively Recruiting

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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

Frequently Asked Questions

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Comparison of Medial Pivot Versus Ultra-Congruent Polyethylene Inserts in Total Knee Replacement Surgery | DecenTrialz