Longterm-Evaluation of Vitelene® Against Standard (VITAS)

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Arthritis; Osteoarthritis, Hip
• Intervention / Treatment: Device: Vitelene; Device: XLPE

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Germany
  • Bendorf, Germany, 56170
    • Fachklinik für Orthopädie, Unfallchirurgie, WirbelsäulenchirurgieMarienhaus Klinikum St. Josef
  • Bochum, Germany, 44791
    • Klinik für Orthopädie und Unfallchirurgie
  • Halle, Germany, 06097
    • Klinik und Poliklinik für Orthopädie
  • Hanover, Germany, 30625
    • Orthopädische Klinik der MHH im Annastift
  • Mülheim, Germany
    • St. Marien Hospital
  • Olsberg, Germany, 59939
    • Elisabeth Klinikum Olsberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

adult patients

Description

Inclusion:

• Minimum age: 18 years
• Maximum age: 75 years
• Indication of cementless THA
• Approval of study participation and treatment according to study protocol
• Physical and mental willingness of adhering to clinical and radiological follow up

Exclusion:

• Patient is not able to join follow up
• Increased risk of anaesthesia according to the "American Society of Anesthesiology": ASA IV
• Tumor disease
• Alcohol and drug dependency
• Permanent cortisone therapy
• Clinical relevant infections
• Pregnancy and planned pregnancy
• Previous interventions like adjustment-osteotomy, treatment of fractures or THA on affected side
• Acute fractures of the affected hip joint
• Patients with bone quality, which doesn´t allow a cementless treatment
• Requirements of clinical relevant deformities (condition after preoperation or bone fracture, leg length discrepancy > 30 mm, Offset-reduction about > 30 mm)
• Small acetabular treatments with 28 mm heads
• Treatments without using ceramic heads
• Treatments which require neck prolonging components

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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®)	Device: Vitelene; THA
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®)	Device: XLPE; THA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Clinical Outcome measured by Harris Hip Score (HHS), Hip disability and osteoarthritis outcome score(HOOS), University of California at Los Angeles Score (UCLA)	After 1, 5, 10 and 15 years

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: Marcus Jäger, Prof. Dr. med, Universitätsklinikum Essen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: October 15, 2012
• First Submitted That Met QC Criteria: October 22, 2012
• First Posted (Estimated): October 24, 2012

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Arthritis; Osteoarthritis, Hip
• Other Study ID Numbers: AAG-G-H-1113