Longterm-Evaluation of Vitelene® Against Standard

Active, not recruiting

• Conditions: Osteoarthritis, Hip; Arthritis
• Interventions: Device: Vitelene; Device: XLPE

• Registration Number: NCT01713062
• Lead Sponsor: Aesculap AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-24
• Primary Completion: 2015-04-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-02
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vitelene	Vitelene	Plasmacup DC® with Vitelene® inlay manufactured by UHMWPE-XE (Ultra High Molecular Weight Polyethylene highly cross-linked with 0.1% Vitamin E) in combination with one of four different Aesculap® stems (Bicontact®, TRJ®, Metha®, Excia®)
XLPE	XLPE	Plasmacup DC® with a standard polyethylene inlay manufactured by UHMWPE-X (Ultra High Molecular Weight Polyethylene highly cross-linked) in combination with one of four different Aesculap® stems (Bicontact®, TRJ®, Metha®, Excia®)

Primary Outcome Measures

Name	Time	Method
Analysis and measurement of oxidation index of the Polyethylene Inlay after Revision	Oxidation index is assessed in case of loosening and revision within 15 years	The Oxidation index is measured after explantation in case of loosening of the inlay

Secondary Outcome Measures

Name	Time	Method
Manifest radiological osteolyses	Measured radiologically after 1, 5, 10 and 15 years
Traceable wear of polyethylene over 0.5 mm	Measured radiologically after 1, 5, 10 and 15 years
Clinical Outcome	After 1, 5, 10 and 15 years	Clinical Outcome measured by Harris Hip Score (HHS), Hip disability and osteoarthritis outcome score(HOOS), University of California at Los Angeles Score (UCLA)

Trial Locations

Locations (7)

Klinikum Dortmund gGmbH - Orthopädische Klinik; 🇩🇪 Dortmund, Germany

Orthopädische Klinik der MHH im Annastift; 🇩🇪 Hannover, Germany

Fachklinik für Orthopädie, Unfallchirurgie, WirbelsäulenchirurgieMarienhaus Klinikum St. Josef; 🇩🇪 Bendorf, Germany

Orthopädische Universitätsklinik Essen; 🇩🇪 Essen, Germany

Klinik für Orthopädie und Unfallchirurgie; 🇩🇪 Bochum, Germany

Elisabeth Klinikum Olsberg; 🇩🇪 Olsberg, Germany

Klinik und Poliklinik für Orthopädie; 🇩🇪 Halle, Germany