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Longterm-Evaluation of Vitelene® Against Standard (VITAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01713062
Recruitment Status : Active, not recruiting
First Posted : October 24, 2012
Last Update Posted : March 19, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Osteoarthritis, Hip Arthritis Device: Vitelene Device: XLPE

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : January 2012
Actual Primary Completion Date : April 24, 2015
Estimated Study Completion Date : April 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E

Group/Cohort Intervention/treatment
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

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

Primary Outcome Measures :
  1. Analysis and measurement of oxidation index of the Polyethylene Inlay after Revision [ Time Frame: 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 :
  1. Manifest radiological osteolyses [ Time Frame: Measured radiologically after 1, 5, 10 and 15 years ]
  2. Traceable wear of polyethylene over 0.5 mm [ Time Frame: Measured radiologically after 1, 5, 10 and 15 years ]
  3. Clinical Outcome [ Time Frame: 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult patients


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01713062

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Fachklinik für Orthopädie, Unfallchirurgie, WirbelsäulenchirurgieMarienhaus Klinikum St. Josef
Bendorf, Germany, 56170
Klinik für Orthopädie und Unfallchirurgie
Bochum, Germany, 44791
Klinikum Dortmund gGmbH - Orthopädische Klinik
Dortmund, Germany, 44137
Orthopädische Universitätsklinik Essen
Essen, Germany, 45147
Klinik und Poliklinik für Orthopädie
Halle, Germany, 06097
Orthopädische Klinik der MHH im Annastift
Hannover, Germany, 30625
Elisabeth Klinikum Olsberg
Olsberg, Germany, 59939
Sponsors and Collaborators
Aesculap AG
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Principal Investigator: Marcus Jäger, Univ.-Prof. Dr. med Universitätsklinikum Essen

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Responsible Party: Aesculap AG Identifier: NCT01713062     History of Changes
Other Study ID Numbers: AAG-G-H-1113
First Posted: October 24, 2012    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Vitamin E
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Growth Substances