NCT01713062Active, not recruitingNot Applicable
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)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Aesculap AG
- Enrollment
- 400
- Locations
- 6
- Primary Endpoint
- Analysis and measurement of oxidation index of the Polyethylene Inlay after Revision
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Manifest radiological osteolyses(Measured radiologically after 1, 5, 10 and 15 years)
- Traceable wear of polyethylene over 0.5 mm(Measured radiologically after 1, 5, 10 and 15 years)
- Clinical Outcome(After 1, 5, 10 and 15 years)
Investigators
Study Sites (6)
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