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Medical utility of artificial intelligence for fracture detection in the emergency department

Systematic Assessment of the Medical Utility of Radiology Artificial Intelligence (SAMURAI) in Fracture Detection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN23087950
Enrollment
45000
Registered
2026-01-08
Start date
2026-02-24
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Patients undergoing X-ray for suspected fracture in the emergency department or minor injuries unit Injury, Occupational Diseases, Poisoning

Interventions

The trial will involve installing a MHRA- and CE-approved AI fracture detection software at each site for 6 months. Clinicians will be able to view AI annotated images to aid in diagnosis when reviewi

Sponsors

Oxford University Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 100 Years

Inclusion criteria

Inclusion criteria: All patients undergoing X-Rays in ED or MIU for a suspected fracture will be eligible for inclusion

Exclusion criteria

Exclusion criteria: 1. Patients under 2 years old 2. Skeletal survey conducted to assess for non-accidental injury 3. Skull, facial bone, dental, and cervical spine X-rays 4. Thoracolumbar spine X-rays in patients under 18 years old 5. Patient has opted out of data sharing on the National Data Opt-Out 6. Patient completes the opt out questionnaire displayed on posters in the waiting room

Design outcomes

Primary

MeasureTime frame
Unnecessary NHS contacts measured via electronic patient record audit of composite endpoints (phone consultations, repeat ED attendances, additional imaging, GP consultations, late fracture clinic referrals, inappropriate early clinical use, unnecessary imaging, immobilization, and sick leave) compared between periods when AI system is active ("On") versus inactive ("Off") throughout the entire 6-month study period (December 2025 – May 2026), with comparison occurring monthly during the alternating On/Off periods.

Secondary

MeasureTime frame
Patient Impact: 1. False negative fracture detection rate measured by comparison of AI algorithm output versus final radiology report at each X-ray during AI "On" periods (December 2025 – May 2026) 2. False positive fracture detection rate measured by comparison of AI algorithm output versus final radiology report at each X-ray during AI "On" periods (December 2025 – May 2026) 3. Number of inappropriate interventions (unnecessary treatments/referrals) measured via electronic patient record audit comparing AI "On" versus AI "Off" periods throughout the 6-month study period 4. Patient-reported outcomes measured using the EQ-5D questionnaire at 1 month post-initial ED/MIU presentation (December 2025 – May 2026) Clinician Impact: 1. Clinician satisfaction and confidence with the AI tool measured using a 5-point Likert scale questionnaire at baseline (December 2025) and 6 months (May 2026) Service Impact: 1. Number of patients referred to Fracture Clinic from ED/MIU measured via electronic patient record and RIS audit comparing AI "On" versus AI "Off" periods throughout the 6-month study period 2. Number of patients admitted to hospital with suspected fractures measured via electronic patient record audit comparing AI "On" versus AI "Off" periods throughout the 6-month study period 3. Number of patients recalled to ED due to missed fractures (false negatives) measured via electronic patient record audit comparing AI "On" versus AI "Off" periods throughout the 6-month study period 4. Number of unplanned reattendances for the same injury measured via electronic patient record audit comparing AI "On" versus AI "Off" periods throughout the 6-month study period 5. Length of Stay (LoS) in ED/MIU for patients with suspected fractures (measured in minutes from registration to discharge) via electronic patient record audit comparing AI "On" versus AI "Off" periods at each patient visit throughout the 6-month study period Technical Performance: 1. Sensitivity and specificity of

Countries

England, United Kingdom

Contacts

Public ContactAlex Novak
Alex.Novak@ouh.nhs.uk+44 (0)1865 231550

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 25, 2026