Active — Not RecruitingNot Applicable

Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty

France, Germany605 participantsStarted 2021-03-08

Plain-language 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

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Clinical Outcome measured with the KSS [performance]

Timeframe: 10 years postoperatively

Trial details

NCT IDNCT04618016

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Osteoarthritis, Knee trials