RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: Uppsala University • ClinicalTrials.gov ID: NCT07863557

Registry updated: 2026-10-09

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Description

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.

Interventions

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

Eligibility criteria

Inclusion Criteria: * Age 18-75 years * Written informed consent * Eligible for a Total Hip Arthroplasty according to local guidelines and appropriate candidate for a dual mobility concept * Diagnosis: Symptomatic osteoarthritis, osteonecrosis, or dysplasia of the hip requiring a hip replacement Exclusion Criteria: * Confirmed dementia or cognitive impairment * Unwillingness to give written informed consent * Age \<18 or \>75 years * Hip fracture (traumatic or pathological) in need of a Total Hip Arthroplasty * Patients who are not deemed suitable for a THA with a Dual Mobility Cup according to local guidelines and routines * Comorbidities that are contraindicators for hip replacement surgery

Conditions

Osteoarthritis Osteonecrosis Dysplasia; Hip

Locations

Uppsala University Hospital — Uppsala, Uppsala County, Sweden

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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