Comparison of Pivotal Medial Polyethylene Versus Ultra-congruent in Total Knee Arthroplasty
Recruiting · NCT06676189 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Clermont-Ferrand
View the official record on ClinicalTrials.gov →Interventions studied
total knee arthroplasty with medial pivot polyethylenetotal knee arthroplasty with ultra-congruent polyethylene
What this trial is about
The aim of this study is to compare the forgotten joint score for the medial pivot polyethylene and ultra-congruent polyethylene which are used in total prosthetic replacement of the knee
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- CHU de Clermont-Ferrand - Clermont-Ferrand, France