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ACTIVE NOT RECRUITING
NCT01713062

Longterm-Evaluation of Vitelene® Against Standard

Sponsor: Aesculap AG

View on ClinicalTrials.gov

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

Interventions

DEVICE

Vitelene

THA

DEVICE

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