Early wear of a Vitamin E-infused liner in a dual-mobility hip replacement
Official title: Early Wear Patterns Detected With CT RSA in Vitamin E-infused Liner Versus Conventional Highly Crosslinked Liner After Total Hip Arthroplasty With Dual Mobility Cups: a Randomized Controlled Trial
Run by Uppsala University · NCT07863557 · Data updated 2026-11-12
This study tests whether a Vitamin E-infused liner in a dual-mobility hip implant wears as little as a conventional liner over two years in adults needing hip replacement.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Uppsala University Academic / other |
| Locations | 1 site (Uppsala, Uppsala County) |
| Status | Recruiting |
| Started | October 8, 2026 |
| Main results expected | October 1, 2033 |
| Study ends | October 1, 2033 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT07863557 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-75 with symptomatic hip osteoarthritis, osteonecrosis, or dysplasia requiring total hip arthroplasty and eligible for a dual mobility cup.
✕Probably not a fit
Patients outside the age range, with cognitive impairment, or without eligibility for a dual-mobility cup may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, randomized, double-blind, non-inferiority trial conducted at Uppsala University Hospital. It compares a BiMobile dual-mobility cup with a Vitamin E-infused polyethylene liner to a conventional polyethylene liner in adults with symptomatic hip OA, osteonecrosis, or dysplasia undergoing total hip arthroplasty. Wear and migration will be measured using CT-based radiostereometric analysis over two years, with extended follow-up to five years for secondary outcomes. The study aims to determine if the VEPE liner is not worse than the conventional liner in early wear, while also monitoring safety, patient satisfaction, and functional outcomes.
Why it matters
Potential benefit: If successful, patients could benefit from reduced wear and potentially longer-lasting hip implants with fewer revisions.
How similar studies have gone: Previous studies of dual-mobility implants have reported low wear and good survival, though evidence specific to VEPE liners in this context is limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Uppsala University Hospital
Uppsala, Uppsala County, Sweden Recruiting
Study contacts
- Principal investigator: Anders Brüggemann, MD, PhD — Department of Surgical Sciences, Uppsala University
- Study coordinator: Anders Brüggemann, MD, PhD
- Email: anders.bruggemann@uu.se
- Phone: +46 707-498242
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.