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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07863557
- Acronym / sponsor ID
- E-type / E-type
- Conditions
- Osteoarthritis, Osteonecrosis, Dysplasia; Hip
- Keywords
- BiMobile Dual Mobility System, Total Hip Arthroplasty, Vitamin E-infused highly crosslinked polyethylene, Computed Tomography-based Radiostereometric Analysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 8 Oct 2026 (actual)
- Primary completion
- 1 Oct 2033 (estimated)
- Study completion
- 1 Oct 2033 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VEPE liner | Active comparator | Device: Total Hip ArthroplastyParticipants 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). |
| PE liner | Experimental | Device: Total Hip ArthroplastyParticipants are randomized to the BiMobile Dual Mobility System with a conventional highly crosslinked polyethylene (PE) liner (Waldemar Link GmbH, Hamburg, Germany). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Hip ArthroplastyAll patients will be operated with an anterolateral or posterior approach using a cemented or uncemented cup (BiMobile, Waldemar Link GmbH, Hamburg, Germany). | Device | PE liner, VEPE liner |
Primary outcome
Wear performance
Time frame: Two years postoperatively.
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.
5 secondary outcomes
Long-term wear performance
Time frame: Five years postoperatively.
Cup stability
Time frame: Two and five years postoperatively.
Harris Hip Score
Time frame: Two and five years postoperatively.
Hip Disability and Osteoarthritis Outcome Score
Time frame: Two and five years postoperatively.
Patient Reported Outcome Scores
Time frame: Two and five years postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anders Brüggemann, MD, PhD principal investigator
Department of Surgical Sciences, Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Total Hip Arthroplasty in people with Osteoarthritis and Osteonecrosis, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anders Brüggemann, MD, PhD (+46 707-498242, anders.bruggemann@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wear performance (time frame: Two years postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.