Trials / Active Not Recruiting
Active Not RecruitingNCT04618016
Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty
Prospective, Randomized, Single-blind, Multinational, Long-term Study for the Evaluation of the Clinical Outcome, Oxidation Profile and Wear Analysis of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 605 (actual)
- Sponsor
- Aesculap AG · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, randomized, single-blind, multinational, long-term study for the evaluation of the clinical outcome, oxidation profile and wear analysis of medium cross-linked Polyethylene with and without Vitamin E for total knee arthroplasty
Conditions
- Osteoarthritis, Knee
- Arthritis, Rheumatoid
- Intra-Articular Fractures
- Joint Instability
- Genu Valgum or Varum
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | UHMWPE with Vitamin E | e.motion Pro (PS and UC) with MXE gliding surface |
| DEVICE | UHMWPE without Vitamin E | e.motion Pro (PS and UC) with β-PE gliding surface |
Timeline
- Start date
- 2021-03-08
- Primary completion
- 2024-12-31
- Completion
- 2034-10-01
- First posted
- 2020-11-05
- Last updated
- 2026-02-27
Locations
8 sites across 2 countries: France, Germany
Source: ClinicalTrials.gov record NCT04618016. Inclusion in this directory is not an endorsement.