OsteoarthritisPhase 4E-typeNCT07863557
E-Type - Early Wear of Polyethylene Liners Used in DMC
A Phase 4 study testing Total Hip Arthroplasty in people with Osteoarthritis and Osteonecrosis, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Osteonecrosis, Dysplasia; Hip
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 8 Oct 2026to 1 Oct 2033
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala, Uppsala County, 751 85
Ulla Ann-Charlotte Claesson, RN, +46 734-697197, ann-charlotte.claesson@uu.se
About this study
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
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.
Read the detailed description
Dual-mobility cups (DMCs) were introduced to reduce the risk of dislocation after total hip arthroplasty (THA) by improving stability while maintaining a large range of motion. Concerns remain regarding polyethylene liner wear due to the larger articulating surface, as wear rates exceeding 0.1 mm/year have been associated with osteolysis and aseptic loosening. Vitamin E-infused highly crosslinked polyethylene (VEPE) has been developed to improve wear resistance, and CT-based radiostereometric analysis (CT-RSA) provides a validated method for assessing implant wear and migration.
The BiMobile Dual Mobility System (Waldemar LINK GmbH) is designed to enhance stability and wear resistance through biocompatible materials and self-centering liners. Although clinical evidence specifically for the BiMobile cup is limited, studies of dual-mobility implants have reported low wear, limited migration, high implant survival, and low rates of loosening.
This study aims to evaluate the performance of the BiMobile dual-mobility cup with a VEPE liner compared with a conventional polyethylene (PE) liner. In a single-centre, randomized, double-blinded non-inferiority trial, patients undergoing THA will be followed for up to five years. The primary objective is to compare in vivo liner wear at two years using CT-RSA. Secondary objectives include evaluation of wear at five years, cup migration and fixation, patient satisfaction, adverse events, and patient-reported outcomes.
All participants will receive a BiMobile dual-mobility cup and will be randomized to either a VEPE or conventional PE liner. CT-RSA examinations will be performed postoperatively and at 6 months, 2 years, and 5 years to measure polyethylene wear, cup migration, and radiological signs of loosening. The study will provide important post-market evidence regarding the long-term safety, fixation, and wear characteristics of the BiMobile system and may help determine whether dual-mobility cups can be more widely used in younger and more active patients.
- Conditions
- Osteoarthritis, Osteonecrosis, Dysplasia; Hip
- Being tested
- Total Hip Arthroplasty
- Keywords
- BiMobile Dual Mobility System, Total Hip Arthroplasty, Vitamin E-infused highly crosslinked polyethylene, Computed Tomography-based Radiostereometric Analysis
- Medical subject headings
- Osteoarthritis, Osteonecrosis, Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyDevice
All patients will be operated with an anterolateral or posterior approach using a cemented or uncemented cup (BiMobile, Waldemar Link GmbH, Hamburg, Germany).
| Study group | Role | What they receive |
|---|---|---|
| VEPE liner | Active comparator | Participants are randomized to the BiMobile Dual Mobility System with a Vitamin E-infused highly crosslinked polyethylene (VEPE) liner (E-Dur, Waldemar Link GmbH, Hamburg, Germany). Receives: Device: Total Hip Arthroplasty |
| PE liner | Experimental | Participants are randomized to the BiMobile Dual Mobility System with a conventional highly crosslinked polyethylene (PE) liner (Waldemar Link GmbH, Hamburg, Germany). Receives: Device: Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wear performance
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.
Measured: Two years postoperatively.
Secondary outcomes (5)
Long-term wear performance
To evaluate the in vivo wear performance of the VEPE liner versus the conventional PE liner using CT-RSA.
Measured: Five years postoperatively.
Cup stability
To evaluate stability of the cup by measuring degree of migration using CT-RSA.
Measured: Two and five years postoperatively.
Harris Hip Score
Harris Hip Score (HHS), a clinician-completed tool scored from 0 to 100, will be used to evaluate hip function, pain, and mobility after hip replacement.
Measured: Two and five years postoperatively.
Hip Disability and Osteoarthritis Outcome Score
The Hip Disability and Osteoarthritis Outcome Score (HOOS), a 40-item, patient-reported questionnaire, will be used to assess the participant's opinions about their hip symptoms and functional limitations.
Measured: Two and five years postoperatively.
Patient Reported Outcome Scores
The EQ-5D form will be used to evaluate the participant's quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: Two and five years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start8 Oct 2026
- Primary completion1 Oct 2033 (estimated)
- Study completion1 Oct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders Brüggemann, MD, PhD, Principal investigator, Department of Surgical Sciences, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863557
- Sponsor's protocol ID
- E-type
- Other IDs
- CIV-ID: 24-10-049578
- Acronym
- E-type
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No