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

NCT04618016 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 605

Last updated 2026-02-27

No results posted yet for this study

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

Conditions

  • Osteoarthritis, Knee
  • Arthritis, Rheumatoid
  • Intra-Articular Fractures
  • Joint Instability
  • Genu Valgum or Varum

Interventions

DEVICE

UHMWPE with Vitamin E

e.motion Pro (PS and UC) with MXE gliding surface

DEVICE

UHMWPE without Vitamin E

e.motion Pro (PS and UC) with β-PE gliding surface

Sponsors & Collaborators

  • Raylytic GmbH

    collaborator INDUSTRY

  • B. Braun Medical France

    collaborator UNKNOWN

  • Aesculap AG

    lead INDUSTRY

Principal Investigators

  • Wolfram Mittelmeier, Prof. Dr. · Orthopädische Uniklinik Rostock, Direktor

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-08
Primary Completion
2024-12-31
Completion
2034-10-31

Countries

  • France
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04618016 on ClinicalTrials.gov