Clinical trial Recruiting at 1 site Interventional Ages 18 to 90

Comparing two types of polyethylene in knee replacement surgery

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

Run by University Hospital, Clermont-Ferrand · NCT06676189 · Data updated 2026-11-12

This study is testing which type of plastic used in knee replacement surgery helps patients feel better and move more easily after their operation.

Quick facts

Study typeInterventional
Ages18 Years to 90 Years
SexAll
Enrollment90 (estimated)
SponsorUniversity Hospital, Clermont-Ferrand
Academic / other
Locations1 site (Clermont-Ferrand)
StatusRecruiting
StartedJune 4, 2024
Main results expectedMarch 2027
Study endsMarch 2027
Registry record updatedJanuary 17, 2025
Trial IDNCT06676189 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals aged 18 to 90 who require a primary total knee replacement due to gonarthrosis.

Probably not a fit

Patients with a history of knee infections, significant deformities, or other surgical contraindications may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the forgotten joint score between medial pivot polyethylene and ultra-congruent polyethylene used in total knee arthroplasty. It involves a prospective, randomized approach with parallel groups to assess the effectiveness of these two types of polyethylene in improving patient outcomes post-surgery. The study focuses on enhancing surgical techniques and implant designs to meet rising patient expectations regarding pain relief and mobility after knee replacement. Participants will undergo total knee arthroplasty with either type of polyethylene, and their recovery will be monitored to evaluate the differences in performance.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes and satisfaction for patients undergoing total knee replacement.

How similar studies have gone: There have been no prior randomized studies comparing these two types of polyethylene, making this approach novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion criteria :

* 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

Exclusion criteria :

* 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 who are subject to a legal protection measure or who are unable to express their constent (Article L1121-8 of the French Public Health Code) and subjects under judicial protection (article L. 1122-2 FPHC)
* Subjects who refuse to participate

Where it's running

  • CHU de Clermont-Ferrand
    Clermont-Ferrand, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.