Trials / Active Not Recruiting
Active Not RecruitingNCT01713062
Longterm-Evaluation of Vitelene® Against Standard
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)
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 400 (actual)
- Sponsor
- Aesculap AG · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vitelene | THA |
| DEVICE | XLPE | THA |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2027-04-01
- Completion
- 2030-06-01
- First posted
- 2012-10-24
- Last updated
- 2025-11-17
Locations
6 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01713062. Inclusion in this directory is not an endorsement.