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臨床試験

E-Type - Early Wear of Polyethylene Liners Used in DMC

NCT: NCT07863557 · NOT_YET_RECRUITING

NCT識別子NCT07863557
ステータスNOT_YET_RECRUITING
開始日2026-10-02
完了2033-10-01
SponsorUppsala University (OTHER)
First posted
Last updated

概要

This is a single-centre, randomized, double-blinded controlled non-inferiority trial that will be conducted at the Orthopaedic Department at Uppsala University Hospital, Uppsala. The aim of the study is to evaluate the performance of a dual mobility acetabular component with a Vitamin E-infused highly crosslinked polyethylene (VEPE) liner compared to a conventional polyethylene (PE) liner in adult patients with symptomatic osteoarthritis, osteonecrosis, or dysplasia of the hip requiring a hip replacement. The assessments will focus on early wear, cup migration, adverse events, and clinical outcomes. Measurements will be conducted using Computed Tomography Radiostereometric Analysis (CT-RSA) instead of traditional radiostereometric analysis. The study hypothesis is that the PE liner will be non-inferior to the VEPE liner in terms of early wear over a two-year period.

公式ソース

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