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Longterm-Evaluation of Vitelene® Against Standard
Sponsor: Aesculap AG
Summary
The purpose of this randomised prospective multicenter longterm study is to evaluate the survival rate of the implant, wear and periprosthetic osteolysis of highly cross-linked polyethylene with and without addition of Vitamin E (UHMWPE-XE vs. UHMWPE-X) in Total Hip Arthroplasty.
Official title: Randomised Prospective Multicenter Longterm-Evaluation of the Survival Rate of the Implant, Wear and Periprosthetic Osteolysis of Highly Cross-linked Polyethylene With and Without Addition of Vitamin E (UHMWPE-XE vs. UHMWPE-X)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
400
Start Date
2012-01
Completion Date
2030-06
Last Updated
2025-11-17
Healthy Volunteers
No
Conditions
Interventions
Vitelene
THA
XLPE
THA
Locations (6)
Fachklinik für Orthopädie, Unfallchirurgie, WirbelsäulenchirurgieMarienhaus Klinikum St. Josef
Bendorf, Germany
Klinik für Orthopädie und Unfallchirurgie
Bochum, Germany
Klinik und Poliklinik für Orthopädie
Halle, Germany
Orthopädische Klinik der MHH im Annastift
Hanover, Germany
St. Marien Hospital
Mülheim, Germany
Elisabeth Klinikum Olsberg
Olsberg, Germany