Longterm-Evaluation of Vitelene® Against Standard (VITAS)

This study is currently recruiting participants.
Verified December 2013 by Aesculap AG
Sponsor:
Information provided by (Responsible Party):
Aesculap AG
ClinicalTrials.gov Identifier:
NCT01713062
First received: October 15, 2012
Last updated: December 5, 2013
Last verified: December 2013
  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 Phase
Osteoarthritis, Hip
Arthritis
Device: Vitelene
Device: XLPE
Phase 4

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 ] [ Designated as safety issue: No ]
    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 ] [ 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)


Estimated Enrollment: 400
Study Start Date: January 2012
Estimated Study Completion Date: December 2029
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713062

Contacts
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

Locations
Germany
Fachklinik für Orthopädie, Unfallchirurgie, WirbelsäulenchirurgieMarienhaus Klinikum St. Josef Recruiting
Bendorf, Germany, 56170
Contact: Joern WP Michael, PD Dr.    +49-2622-708-0      
Principal Investigator: Joern WP Michael, PD Dr.         
Klinik für Orthopädie und Unfallchirurgie Recruiting
Bochum, Germany, 44791
Contact: Christoph von Schulze Pellengahr, Prof. Dr.    +49-234-612-0      
Principal Investigator: Christoph von Schulze Pellengahr, Prof. Dr.         
Klinikum Dortmund gGmbH - Orthopädische Klinik Withdrawn
Dortmund, Germany, 44137
Orthopädische Universitätsklinik Essen Recruiting
Essen, Germany, 45147
Contact: Marcus Jäger, Prof. Dr.    +49-201-7233181      
Principal Investigator: Marcus Jäger, Prof. Dr.         
Klinik und Poliklinik für Orthopädie Recruiting
Halle, Germany, 06097
Contact: Karl-Stefan Delank, Prof. Dr.    +49-345-5574-805    orthopaedie@uk-halle.de   
Principal Investigator: Karl-Stefan Delank, Prof. Dr.         
Orthopädische Klinik der MHH im Annastift Recruiting
Hannover, Germany, 30625
Contact: Henning Windhagen, Prof. Dr.    +49-511-5354-0      
Principal Investigator: Henning Windhagen, Prof. Dr.         
Elisabeth Klinikum Olsberg Recruiting
Olsberg, Germany, 59939
Contact: Axel Wilke, Prof.Dr.Dr.    +49-2962-803-0      
Principal Investigator: Axel Wilke, Prof.Dr.Dr.         
Sponsors and Collaborators
Aesculap AG
Investigators
Principal Investigator: Marcus Jäger, Univ.-Prof. Dr. med Universitätsklinikum Essen
  More Information

No publications provided

Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT01713062     History of Changes
Other Study ID Numbers: AAG-G-H-1113
Study First Received: October 15, 2012
Last Updated: December 5, 2013
Health Authority: Germany: German Institute of Medical Documentation and Information

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014