Femoral Neck FracturesDUALITYNCT03909815
Dual Mobility Cups in Hip Fracture Patients
A study testing Dual mobility cup and Standard cup in people with Femoral Neck Fractures, run by Uppsala University at 2 sites in 2 countries.
Trial summary
Our aim is to develop a strategy that reduces the risk of dislocations after total hip arthroplasty surgery performed due to femoral neck fracture. We therefore perform a register-nested, pragmatic, randomized controlled trial to investigate the safety and efficacy of dual mobility cups that were designed to minimize… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Dual mobility cup and Standard cup
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 Jan 2020to 24 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Written informed consent
- Diagnosis: displaced femoral neck fracture type AO 31-B2 or B3/Garden type 3 or 4
- Eligible for THA according to local guidelines and routines
Who cannot join
- Previous inclusion of contralateral hip
- Delayed fracture surgery (date of injury >7 days prior to date of randomization)
- Pathological or stress fracture of the femoral neck, or fracture adjacent to a previous ipsilateral hip implant
- Inability or unwillingness to give written consent
- Dementia (as diagnosed by the screening physician)
- Unavailability of both interventions for a study subject (e.g., implants being out of stock, or lack of the individual surgeon's expertise to perform either procedure)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Do Dual Mobility Cups Prevent Dislocation After Total Hip Arthroplasty Performed Due to Femoral Neck Fracture? A Registry-based, Pragmatic, Randomized Controlled Trial Comparing Dual Mobility With Standard Cups
Our aim is to develop a strategy that reduces the risk of dislocations after total hip arthroplasty surgery performed due to femoral neck fracture. We therefore perform a register-nested, pragmatic, randomized controlled trial to investigate the safety and efficacy of dual mobility cups that were designed to minimize the risk of dislocation in the large and fragile group of elderly patients with femoral neck fractures.
Read the detailed description
Total hip arthroplasty (THA) is regularly performed in patients with a femoral neck fracture. However, dislocation is very common after THA in hip fracture patients, and this complication is deleterious to health and quality of life. The dual mobility cup offers a technical solution that potentially reduces the risk of dislocation. There is however no high-level evidence to support the general use of dual mobility cups in patients with displaced femoral neck fractures, and the purpose of the proposed study is to provide evidence to support or refute the use of this concept in the very large group of hip fracture patients.
We a register-nested, pragmatic randomized controlled trial (RCT) to investigate the safety and efficacy of dual mobility cups that were designed to minimize the risk of dislocation after THA. Our aim is thus to investigate whether the incidence of dislocations after THA surgery performed due to femoral neck fracture can be reduced by the use of this device.
The intervention group receives a dual mobility cup (of any brand that is in general use in Sweden), and the control group receives a standard cup (of any brand that is in general use in Sweden). The choice of cup or stem fixation (cemented or uncemented), femoral head size, brand of stem type, surgical approach, antibiotic prophylaxis, and postoperative mobilization are up to the surgeon's choice and the routines that are relevant at each study site.
The necessary infrastructure for this register-nested RCT is present within the Swedish Hip Arthroplasty Register (SHAR) and the Swedish Fracture Register (SFR). Pre-operative registration of fractures is already established within the SFR, and an online platform to screen, include and randomize eligible patients is established. Cross-matching of data from the SFR and the SHAR with the database of the Swedish Patient Register (SPR) is performed in order to catch endpoint not routinely collected by the SHAR.
Expanded recruitment in collaboration with UK, WHITE 12-Duality, started 10/09/2022. https://www.isrctn.com/ISRCTN11895196
- Conditions
- Femoral Neck Fractures
- Being tested
- Dual mobility cup, Standard cup
- Keywords
- total hip arthroplasty, dual mobility cup, dislocation, mortality, periprosthetic joint infection, health economy
- Medical subject headings
- Femoral Neck Fractures, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual mobility cupDevice
Patients with a displaced femoral neck fracture eligible for THA receive a dual mobility cup, as opposed to a standard cup in the control group.
Standard cupDevice
Patients with a displaced femoral neck fracture eligible for THA receive a standard cup, as opposed to a dual mobility cup in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Insertion of dual mobility cup Receives: Device: Dual mobility cup |
| Control | Active comparator | Insertion of standard cup Receives: Device: Standard cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dislocation
Dislocation will be ascertained by identifying the occurrence of any closed or open reduction of the previously inserted THA (the "index joint") within one year after surgery.
Measured: 1 year after index surgery
Secondary outcomes (6)
Any re-operation of the index THA
Re-operation will be defined as the occurrence of any surgical procedure performed on the previously treated hip within one year after surgery.
Measured: 1 year after index surgery
Periprosthetic joint infection
Periprosthetic joint infection will be defined as the occurrence of any sign of deep infection around the previously inserted THA within one year after surgery, defined by registration of ICD or NOMESCO codes.
Measured: 1 year after index surgery
Patient-reported outcome
Patient-reported outcome as assessed by EQ-5D-VAS (routinely collected by the SFR at index surgery in order to obtain pre-trauma baseline, and 1 year post-operatively)
Measured: 1 year after index surgery
Short-term mortality
90-day mortality, as registered in the NPR
Measured: 90 days after index surgery
Medium-term mortality
365-day mortality, as registered in the NPR
Measured: 365 days after index surgery
Cost-effectiveness
Procedural costs for intervention and control treatment will be recorded at all sites, ensuring documentation of baseline costs for the two treatment alternatives. Procedural costs of admissions for closed reductions as well as for reoperations will also be collected from all units.
Measured: 1 year after index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start17 Jan 2020
- Primary completion24 Sep 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck FracturesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Sponsor
- Investigators
- Stergios Lazarinis, MD, PhD, Study chair, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909815
- Sponsor's protocol ID
- 2018-101
- Other IDs
- ISRCTN11895196
- Acronym
- DUALITY
- Status last verified
- Sep 2025
- First submitted
- 8 Apr 2019
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hailer NP, Griffin XL, Mukka S, Lakic TG, Appelbe D, Skoldenberg O, Lamb SE, Ostlund O, Wolf O; DUALITY Investigators. Dual mobility versus standard cups in total hip replacement for displaced femoral neck fractures (Duality): an international, multicentre, randomised, controlled, superiority trial. Lancet. 2026 Jul 25;408(10552):348-356. doi: 10.1016/S0140-6736(26)00759-2. Epub 2026 Jul 2.
PubMed 42392114Wolf O, Mukka S, Notini M, Moller M, Hailer NP; DUALITY GROUP. Study protocol: The DUALITY trial-a register-based, randomized controlled trial to investigate dual mobility cups in hip fracture patients. Acta Orthop. 2020 Oct;91(5):506-513. doi: 10.1080/17453674.2020.1780059. Epub 2020 Jun 22.
PubMed 32567472
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Dual Mobility Cups Prevent Dislocation After Total Hip Arthroplasty Performed Due to Femoral Neck Fracture? A Registry-based, Pragmatic, Randomized Controlled Trial Comparing Dual Mobility With Standard Cups
- ClinicalTrials.gov ID
- NCT03909815
- Acronym / sponsor ID
- DUALITY / 2018-101
- Conditions
- Femoral Neck Fractures
- Keywords
- total hip arthroplasty, dual mobility cup, dislocation, mortality, periprosthetic joint infection, health economy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 10 Apr 2019 (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.
Our aim is to develop a strategy that reduces the risk of dislocations after total hip arthroplasty surgery performed due to femoral neck fracture. We therefore perform a register-nested, pragmatic, randomized controlled trial to investigate the safety and efficacy of dual mobility cups that were designed to minimize the risk of dislocation in the large and fragile group of elderly patients with femoral neck fractures.
Detailed description
Total hip arthroplasty (THA) is regularly performed in patients with a femoral neck fracture. However, dislocation is very common after THA in hip fracture patients, and this complication is deleterious to health and quality of life. The dual mobility cup offers a technical solution that potentially reduces the risk of dislocation. There is however no high-level evidence to support the general use of dual mobility cups in patients with displaced femoral neck fractures, and the purpose of the proposed study is to provide evidence to support or refute the use of this concept in the very large group of hip fracture patients.
We a register-nested, pragmatic randomized controlled trial (RCT) to investigate the safety and efficacy of dual mobility cups that were designed to minimize the risk of dislocation after THA. Our aim is thus to investigate whether the incidence of dislocations after THA surgery performed due to femoral neck fracture can be reduced by the use of this device.
The intervention group receives a dual mobility cup (of any brand that is in general use in Sweden), and the control group receives a standard cup (of any brand that is in general use in Sweden). The choice of cup or stem fixation (cemented or uncemented), femoral head size, brand of stem type, surgical approach, antibiotic prophylaxis, and postoperative mobilization are up to the surgeon's choice and the routines that are relevant at each study site.
The necessary infrastructure for this register-nested RCT is present within the Swedish Hip Arthroplasty Register (SHAR) and the Swedish Fracture Register (SFR). Pre-operative registration of fractures is already established within the SFR, and an online platform to screen, include and randomize eligible patients is established. Cross-matching of data from the SFR and the SHAR with the database of the Swedish Patient Register (SPR) is performed in order to catch endpoint not routinely collected by the SHAR.
Expanded recruitment in collaboration with UK, WHITE 12-Duality, started 10/09/2022. https://www.isrctn.com/ISRCTN11895196
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Dual mobility cupInsertion of dual mobility cup |
| Control | Active comparator | Device: Standard cupInsertion of standard cup |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Diagnosis: displaced femoral neck fracture type AO 31-B2 or B3/Garden type 3 or 4
- Eligible for THA according to local guidelines and routines
Key exclusion criteria (6 listed)
- Previous inclusion of contralateral hip
- Delayed fracture surgery (date of injury >7 days prior to date of randomization)
- Pathological or stress fracture of the femoral neck, or fracture adjacent to a previous ipsilateral hip implant
- Inability or unwillingness to give written consent
- Dementia (as diagnosed by the screening physician)
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 |
|---|---|---|
| Dual mobility cupPatients with a displaced femoral neck fracture eligible for THA receive a dual mobility cup, as opposed to a standard cup in the control group. | Device | Intervention |
| Standard cupPatients with a displaced femoral neck fracture eligible for THA receive a standard cup, as opposed to a dual mobility cup in the experimental group. | Device | Control |
Primary outcome
Dislocation
Time frame: 1 year after index surgery
Dislocation will be ascertained by identifying the occurrence of any closed or open reduction of the previously inserted THA (the "index joint") within one year after surgery.
6 secondary outcomes
Any re-operation of the index THA
Time frame: 1 year after index surgery
Periprosthetic joint infection
Time frame: 1 year after index surgery
Patient-reported outcome
Time frame: 1 year after index surgery
Short-term mortality
Time frame: 90 days after index surgery
Medium-term mortality
Time frame: 365 days after index surgery
Cost-effectiveness
Time frame: 1 year after index surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Derived from this study: PubMed 42392114Hailer NP, Griffin XL, Mukka S, Lakic TG, Appelbe D, Skoldenberg O, Lamb SE, Ostlund O, Wolf O; DUALITY Investigators. Dual mobility versus standard cups in total hip replacement for displaced femoral neck fractures (Duality): an international, multicentre, randomised, controlled, superiority trial. Lancet. 2026 Jul 25;408(10552):348-356. doi: 10.1016/S0140-6736(26)00759-2. Epub 2026 Jul 2.
- Derived from this study: PubMed 32567472Wolf O, Mukka S, Notini M, Moller M, Hailer NP; DUALITY GROUP. Study protocol: The DUALITY trial-a register-based, randomized controlled trial to investigate dual mobility cups in hip fracture patients. Acta Orthop. 2020 Oct;91(5):506-513. doi: 10.1080/17453674.2020.1780059. Epub 2020 Jun 22.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Stergios Lazarinis, MD, PhD study chair
Uppsala University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual mobility cup and Standard cup in people with Femoral Neck Fractures, run by Uppsala University at 2 sites in 2 countries.
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 3 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: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden, United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dislocation (time frame: 1 year after index surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03909815, which also lists 2 linked publications.
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 3 Oct 2025.