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Active Not Recruiting
NCT04618016
Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty
Conditions: Osteoarthritis, Knee, Arthritis, Rheumatoid, Intra-Articular Fractures, Joint Instability, Genu Valgum or Varum
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Enrollment: 605
Sponsor: Aesculap AG
Location: Hôpital Sud - CHU de Grenoble Échirolles Isere
Summary
Prospective, randomized, single-blind, multinational, long-term study for the evaluation of the clinical outcome, oxidation profile and wear analysis of medium cross-linked Polyethylene with and without Vitamin E for total knee arthroplasty
Eligibility Criteria
Inclusion Criteria:
* Indication for a total knee replacement with a mobile-bearing UC or PS inlay
* Written informed consent for participating at the clinical study
* Willingness and mental ability to participate at the long-term follow-up examinations
Exclusion Criteria:
* Patient age \< 18 and \> 80 years
* Pregnancy
* High risk patients (ASA class \>3)
Source: ClinicalTrials.gov (NCT04618016). StuddyBuddy aggregates publicly available trial information.
