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

Condition(s) studied

Investigational drug(s) / intervention(s)

Total Hip Arthroplasty: All patients will be operated with an anterolateral or posterior approach using a cemented or uncemented cup (BiMobile, Waldemar Link GmbH, Hamburg, Germany).

Study summary

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.

Eligibility

Primary outcome measure(s)

• Wear performance — Two years postoperatively.
  To compare the in vivo wear performance of a VEPE liner versus a conventional PE liner using CT-RSA in patients undergoing total hip arthroplasty with a dual mobility cup.

Trial sites (1)

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