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 ]
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