E-Type - Early Wear of Polyethylene Liners Used in DMC
NCT:NCT07863557 · NOT_YET_RECRUITING
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简要摘要
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.
官方来源
在 ClinicalTrials.gov 上查看 →数据来自 ClinicalTrials.gov API。有关最新状态,请参阅官方记录。