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
  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: June 2030
Estimated Primary Completion Date: June 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 26, 2014
Health Authority: Germany: German Institute of Medical Documentation and Information

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

ClinicalTrials.gov processed this record on October 20, 2014