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

Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Nov 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different types of materials used in total knee replacement surgery: medial pivot polyethylene and ultra-congruent polyethylene. The goal is to see which material helps patients feel like they have "forgotten" about their knee joint after the surgery, indicating a better quality of life and function.

To participate in this study, you need to be between 18 and 90 years old and have been approved for a primary knee replacement due to knee arthritis, known as gonarthrosis. You'll also need to be able to give your consent to join the study and have social security coverage. If you have certain conditions, like a recent infection in the knee or significant deformities, you won't be eligible. If you join the trial, you can expect to be part of a group that is trying to improve knee replacement outcomes for future patients. The study is currently looking for participants.

Gender

ALL

Eligibility 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