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ACTIVE NOT RECRUITING
NCT04618016

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

Sponsor: Aesculap AG

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

605

Start Date

2021-03-08

Completion Date

2034-10

Last Updated

2026-02-27

Healthy Volunteers

No

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

Locations (8)

Hôpital Sud - CHU de Grenoble

Échirolles, Isere, France

CHU Amiens-Picardie

Amiens, France

Lukas Krankenhaus

Bünde, North Rhine-Westphalia, Germany

Brüderhaus Koblenz

Koblenz, Rhineland-Palatinate, Germany

Park-Klinik Weißensee

Berlin, Germany

Waldkliniken Eisenberg

Eisenberg, Germany

Krankenhaus Reinbek, St. Adolf Stift

Reinbek, Germany

Universitätsklinikum Rostock, Klinik für Orthopädie

Rostock, Germany