Clinical Trial

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

Study acronym: VIKEP
Active, Not Recruiting
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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
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2020-11-04; most recent amendment 2026-02-25.
Status change: Recruiting → Active, Not Recruiting 2025-01-08
Status change: Not Yet Recruiting → Recruiting 2021-03-15
Trial Details
NCT Number NCT04618016
Lead Sponsor Aesculap AG
Collaborators: Raylytic GmbH, B. Braun Medical France
Conditions Osteoarthritis, Knee, Arthritis, Rheumatoid, Intra-Articular Fractures, Joint Instability, Genu Valgum or Varum
Enrollment 605 participants
Start Date 2021-03-08
Primary Completion 2024-12-31 (estimated)
Study Completion 2034-10 (estimated)
Updated on ClinicalTrials.gov 2026-02-27