AI-assisted fracture detection on emergency X-rays — a randomized trial that made time in the department, not accuracy, the primary outcome (NCT06754137)
A multicentre pragmatic randomized controlled trial in patients with a suspected fracture after trauma, assigning physicians to interpret X-rays with or without AI support. The primary outcome is not diagnostic accuracy but the time from triage to completion of emergency department treatment. Planned enrollment 1,667; started October 2025 and completed April 2026.
Trial overview (primary data)
- StatusCompleted
- ConditionsBone Fractures
- InterventionsDIAGNOSTIC_TEST: BoneView AI-Assisted Radiograph Interpretation
- SponsorSalzburger Landeskliniken
- Target enrollment1,667 participants
- Period2025-10-01 〜 2026-04-30
Key points
- A multicentre pragmatic randomized controlled trial in patients aged 2 years or older with a suspected fracture after trauma, assigned to AI-assisted or unassisted interpretation.
- The primary outcome is the time from triage to completion of emergency department treatment, not diagnostic accuracy.
- Secondary outcomes cover physician diagnostic confidence, use of additional imaging, missed fractures, and diagnostic accuracy.
- The record states that at the participating hospitals the formal radiology report generally does not arrive before the patient leaves the emergency department.
- Planned enrollment 1,667; started October 2025 and completed April 2026. All final diagnoses and treatment decisions remained with the treating physician.
- The primary endpoint is time from triage to completion of emergency care rather than diagnostic accuracy, which moves to secondary.
1An emergency X-ray gets read twice
When an X-ray is taken in the emergency department, the frontline physician reads it on the spot, and the formal report from a radiologist arrives afterwards. What the record of this trial states plainly is the operational reality at the participating hospitals: that report generally does not arrive before the patient has left.
In other words, at the moment treatment is decided, the treating physician is relying on a single reading. Placing AI at that point is less a contest over whether it beats a specialist than a question of whether it can fill the window in which specialist judgment is unavailable.
2What it means to make time the primary outcome
Most medical-AI trials put diagnostic accuracy at the centre. This one chose the time from triage to completion of emergency department treatment, and moved accuracy to the secondary outcomes. In an emergency department, reading correctly and keeping patients moving are different kinds of value, and the second one feeds directly into how many people the hospital can take.
Measuring diagnostic confidence, use of additional imaging, and missed fractures alongside it is an attempt to see from several angles how AI changes what physicians do. The result figures are not part of this registry record.
3One of the few trials that reached an answer
Of the 750 medical-AI clinical trials this site holds as of 2026-08-28, 164 are recorded as completed — 22 percent of the total. Another 247 are recruiting and 215 have not begun recruiting, so 62 percent are still on their way to a result. This trial began in October 2025 and completed in April 2026, placing it in the minority that finished within seven months.
Clinical evaluation of medical AI has not accumulated results at anything like the rate at which trials are registered. Against that backdrop, a pragmatic randomized trial that reached completion carries weight as a reference point.
4What to place as the primary endpoint
Most medical AI trials place diagnostic accuracy as the primary endpoint. This one chose something else.
When an X-ray is taken in the emergency department, the front-line physician reads it there and the formal radiology report arrives later. The record states explicitly that at the participating hospitals that report ordinarily does not arrive before the patient leaves.
Measuring diagnostic confidence, use of additional imaging and missed fractures alongside is a design for seeing from several angles how AI changes physician behaviour.
Why it matters
Judging imaging AI on the correctness of a reading alone misses what emergency practice actually asks for: clearing congestion, holding down extra imaging, and steadying confidence. Making time the primary outcome is one example of measuring the effect of an AI deployment in the metrics by which a hospital is run.
FAQ
Does the AI diagnose in place of the physician?
Why choose time rather than accuracy as the primary outcome?
Are the results available?
Sources (primary)
Source: ClinicalTrials.gov (U.S. NIH/NLM, public domain). This site does not provide medical advice. Verify the latest and exact details with the official source. This site is not endorsed or certified by the NIH/NLM.
- ClinicalTrials.gov (study record, original)
- NCT ID: NCT06754137