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An investigation in people aged 60 years and over with a hip fracture to determine whether fixing the broken hip bone or replacing the hip joint gives the patient a better quality of life after 4 months

World Hip Trauma Evaluation – FRUITI: Fix or Replace Undisplaced Intracapsular fractures Trial of Interventions

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN28566489
Enrollment
878
Registered
2021-05-14
Start date
2021-06-10
Completion date
Unknown
Last updated
2024-10-15

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

Conditions

Minimally displaced intracapsular hip fracture Musculoskeletal Diseases Fracture of neck of femur

Interventions

WHiTE 11-FRUITI 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 compa

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Platform inclusion: All patients 60 years of age and over presenting to a WHiTE recruitment centre for treatment of a hip fracture Additional inclusion criteria for FRUITI: A minimally displaced intracapsular hip fracture that in the opinion of the treating surgeon may benefit from surgical treatment

Exclusion criteria

Exclusion criteria: Platform: Does not meet inclusion criteria Additional exclusion criteria for FRUITI: 1. The fracture is only apparent on cross-sectional imaging 2. In the opinion of the treating surgeon the fracture cannot be fixed without a reduction manoeuvre 3. The fracture is complicated by local tumour deposits 4. There is clinically relevant pre-existing osteoarthrosis (OA) of the ipsilateral hip joint

Design outcomes

Primary

MeasureTime frame
Health-related quality of life measured using the EuroQol EQ-5D-5L at baseline (retrospective pre-injury), 6 weeks, 4, 12, 24, 36, 48 and 60 months post-diagnosis of a hip fracture

Secondary

MeasureTime frame
1. Subjective mobility status measured using the UK National Hip Fracture Database Mobility Scale at 6 weeks, 4 and 12 months post-diagnosis of a hip fracture 2. 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 3. Mortality risk using death notification up to 12 months post-diagnosis of a hip fracture 4. 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 5. 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 6. Pain measured using a visual analogue scale at 6 weeks, 4 and 12 months post-diagnosis of a hip fracture 7. Objective mobility status measured using the Short Physical Performance Battery at 6 weeks post-diagnosis of a hip fracture

Countries

England, Scotland, United Kingdom, Wales

Contacts

Public ContactRhys Painton
white11-Fruiti@ndorms.ox.ac.uk+44 (0)1865 223111

Outcome results

None listed

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