WHITE 12-DUALITY: An investigation of people 65 years and over with a broken hip to determine whether using a hip replacement with modified mobility (Dual mobility cup) can reduce the rate of hip dislocation in the first year after hip fracture surgery

World Hip Trauma Evaluation 12: Dual mobility versus standard articulation total hip replacement in the treatment of older adults with a hip fracture (DUALITY)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11895196

Enrollment

450

Registered

2022-08-26

Start date

2022-09-10

Completion date

Unknown

Last updated

2022-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Displaced intracapsular hip fracture Musculoskeletal Diseases

Interventions

WHiTE 12-DUALITY is a randomised comparison appended to the World Hip Trauma Evaluation (WHiTE ) Platform. WHiTE is a platform trials framework, designed to efficiently deliver multiple randomised com

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Platform inclusion: Aged 60 years old and over presenting to a WHiTE recruitment centre for treatment of a hip fracture Additional inclusion criteria for DUALITY: Adults aged 65 years old and over with a displaced intracapsular hip fracture who meet the accepted criteria for consideration of a total hip replacement as per current NICE guidance

Exclusion criteria

Exclusion criteria: Platform: Does not meet inclusion criteria Additional exclusion criteria for DUALITY: 1. Delayed fracture surgery (date of presentation to recruitment centre more than seven days prior to the date of randomisation) 2. Pathological or stress fracture of the femoral neck 3. Fracture adjacent to a previous ipsilateral hip implant, such as a previously inserted screw or plate

Design outcomes

Primary

Measure	Time frame
The adjusted risk of dislocation treated by open or closed reduction within 12 months post diagnosis of a hip fracture. Dislocation events will be obtained through participant-reported complications via medical follow up Case Report Forms and review of the participants’ medical records.	—

Secondary

Measure	Time frame
1. Reoperation: any surgical procedure performed on the index total hip replacement within 12 months post diagnosis of a hip fracture 2. Implant-related infection within 12 months post diagnosis of a hip fracture: There is no consistent international consensus on the diagnosis of implant-related deep infection. Here, this will be defined clinically by the treating surgical team, as a diagnosis recorded in the participants’ medical records. 3. Subjective mobility status measured using the modified New Mobility Score at 6 weeks, 4 and 12 months post-diagnosis of a hip fracture 4. Residential status measured using the UK National Hip Fracture Database Residential Status at 6 weeks, 4 and 12 months post-diagnosis of a hip fracture 5. Mortality risk using death notification up to 12 months post-diagnosis of a hip fracture 6. Risk and pattern of complications measured using a bespoke complications questionnaire and routinely collected hospital data up to 5 years post-diagnosis of a hip fracture 7. Resource use from an NHS and personal social services perspective calculated using a bespoke resource use questionnaire up to 12 months post-diagnosis of a hip fracture	—

Measure

Time frame

1. Reoperation: any surgical procedure performed on the index total hip replacement within 12 months post diagnosis of a hip fracture 2. Implant-related infection within 12 months post diagnosis of a hip fracture: There is no consistent international consensus on the diagnosis of implant-related deep infection. Here, this will be defined clinically by the treating surgical team, as a diagnosis recorded in the participants’ medical records. 3. Subjective mobility status measured using the modified New Mobility Score at 6 weeks, 4 and 12 months post-diagnosis of a hip fracture 4. Residential status measured using the UK National Hip Fracture Database Residential Status at 6 weeks, 4 and 12 months post-diagnosis of a hip fracture 5. Mortality risk using death notification up to 12 months post-diagnosis of a hip fracture 6. Risk and pattern of complications measured using a bespoke complications questionnaire and routinely collected hospital data up to 5 years post-diagnosis of a hip fracture 7. Resource use from an NHS and personal social services perspective calculated using a bespoke resource use questionnaire up to 12 months post-diagnosis of a hip fracture

—

Countries

England, United Kingdom, Wales

Contacts

Public ContactKate Herbert

white12-duality@ndorms.ox.ac.uk+44(0)1865 223115

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 4, 2026