Clinical Trial: Longterm-Evaluation of Vitelene® Against Standard

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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.

Detailed Summary:
Sponsor: Aesculap AG

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)


Original Secondary Outcome: Same as current

Information By: Aesculap AG

Dates:
Date Received: October 15, 2012
Date Started: January 2012
Date Completion: April 2030
Last Updated: March 20, 2017
Last Verified: March 2017