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โ† Trials
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E-Type - Early Wear of Polyethylene Liners Used in DMC

RecruitingPhase 4Ages 18 Years - 75 YearsAllUppsala University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Total Hip Arthroplasty
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Where

1 site
Uppsala University Hospital
Uppsala, Sweden
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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