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)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

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NCT06676189


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