Longterm-Evaluation of Vitelene® Against Standard (VITAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Aesculap AG
Sponsor:
Information provided by (Responsible Party):
Aesculap AG
ClinicalTrials.gov Identifier:
NCT01713062
First received: October 15, 2012
Last updated: June 26, 2014
Last verified: June 2014

October 15, 2012
June 26, 2014
January 2012
June 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
The Oxidation index is measured after explantation in case of loosening of the inlay
Same as current
Complete list of historical versions of study NCT01713062 on ClinicalTrials.gov Archive Site
  • Manifest radiological osteolyses [ Time Frame: Measured radiologically after 1, 5, 10 and 15 years ] [ Designated as safety issue: No ]
  • Traceable wear of polyethylene over 0.5 mm [ Time Frame: Measured radiologically after 1, 5, 10 and 15 years ] [ Designated as safety issue: No ]
  • Clinical Outcome [ Time Frame: After 1, 5, 10 and 15 years ] [ Designated as safety issue: No ]
    Clinical Outcome measured by Harris Hip Score (HHS), Hip disability and osteoarthritis outcome score(HOOS), University of California at Los Angeles Score (UCLA)
Same as current
Not Provided
Not Provided
 
Longterm-Evaluation of Vitelene® Against Standard
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

adult patients

  • Osteoarthritis, Hip
  • Arthritis
  • Device: Vitelene
    THA
  • Device: XLPE
    THA
  • 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®)
    Intervention: Device: Vitelene
  • 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®)
    Intervention: Device: XLPE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
June 2030
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Anne Katrin Wacker +49-7461-95-1509 anne_katrin.wacker@aesculap.de
Contact: Andrea Weiler, Dr. +49-7461-95-2721 andrea.weiler@aesculap.de
Germany
 
NCT01713062
AAG-G-H-1113
No
Aesculap AG
Aesculap AG
Not Provided
Principal Investigator: Marcus Jäger, Univ.-Prof. Dr. med Universitätsklinikum Essen
Aesculap AG
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP