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NCT07863557
E-Type - Early Wear of Polyethylene Liners Used in DMC
Conditions: Osteoarthritis, Osteonecrosis, Dysplasia; Hip
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 40
Sponsor: Uppsala University
Location: Uppsala University Hospital Uppsala Uppsala County
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 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 \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
Source: ClinicalTrials.gov (NCT07863557). StuddyBuddy aggregates publicly available trial information.