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Longterm-Evaluation of Vitelene® Against Standard (VITAS)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01713062
First Posted: October 24, 2012
Last Update Posted: March 21, 2017
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.
Information provided by (Responsible Party):
Aesculap AG
  Purpose
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 Intervention
Osteoarthritis, Hip Arthritis Device: Vitelene Device: XLPE

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Aesculap AG:

Primary Outcome Measures:
  • 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:
  • Manifest radiological osteolyses [ Time Frame: Measured radiologically after 1, 5, 10 and 15 years ]
  • Traceable wear of polyethylene over 0.5 mm [ Time Frame: Measured radiologically after 1, 5, 10 and 15 years ]
  • 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)


Enrollment: 400
Study Start Date: January 2012
Estimated Study Completion Date: April 2030
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01713062


Locations
Germany
Fachklinik für Orthopädie, Unfallchirurgie, WirbelsäulenchirurgieMarienhaus Klinikum St. Josef
Bendorf, Germany, 56170
Klinik für Orthopädie und Unfallchirurgie
Bochum, Germany, 44791
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
Investigators
Principal Investigator: Marcus Jäger, Univ.-Prof. Dr. med Universitätsklinikum Essen
  More Information

Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT01713062     History of Changes
Other Study ID Numbers: AAG-G-H-1113
First Submitted: October 15, 2012
First Posted: October 24, 2012
Last Update Posted: March 21, 2017
Last Verified: March 2017

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


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