Comparing two types of polyethylene in knee replacement surgery
Comparison of Pivotal Medial Polyethylene Versus Ultra-congruent in Total Knee Arthroplasty
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT06676189 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 90 who require a primary total knee replacement due to gonarthrosis.
Not a fit: Patients with a history of knee infections, significant deformities, or other surgical contraindications may not benefit from this study.
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 performed: There have been no prior randomized studies comparing these two types of polyethylene, making this approach novel.
Eligibility criteria
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 this trial is running
Clermont-Ferrand
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Principal investigator: Stéphane DESCAMPS — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.