Clinical Trial

Artificial Intelligence Algorithm for the Interpretation of Traumatic Bone Radiographs

Study acronym: AI-Traumat
Active, Not Recruiting
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Record status
This record was last updated January 9, 2026 (before its estimated March 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
This diagnostic study aims to compare the performance of an artificial intelligence (AI) algorithm designed to assist in the interpretation of traumatic bone radiographs (all anatomical regions excluding the thorax) with that of human readers, including emergency medicine and family medicine residents as well as senior physicians (one emergency medicine specialist and one orthopedic surgeon). The study follows a paired reader study design: identical anonymized radiographic images are independently interpreted by the AI system and by human readers. The reference standard ("gold standard") will be defined by the consensus reading of the two senior physicians. Inter-observer agreement (kappa statistics) between the AI, residents, and senior reference readings will be estimated, and false negatives and false positives will be analyzed by lesion type and anatomical location.
Trial Details
NCT Number NCT07329881
Lead Sponsor Hôpital Universitaire Sahloul
Conditions Trauma (Including Fractures)
Enrollment 500 participants
Start Date 2025-11-01
Primary Completion 2026-03-30 (estimated)
Study Completion 2026-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-09