RecruitingNot ApplicableNCT06676189
Comparison of Pivotal Medial Polyethylene Versus Ultra-congruent in Total Knee Arthroplasty
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
90 participants
Start Date
Jun 4, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Min Age: 18 YearsMax Age: 90 Years
Inclusion Criteria3
- 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 Criteria8
- 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
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Interventions
DEVICEtotal knee arthroplasty with medial pivot polyethylene
total knee arthroplasty with medial pivot polyethylene
DEVICEtotal knee arthroplasty with ultra-congruent polyethylene
total knee arthroplasty with ultra-congruent polyethylene
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06676189
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