Artificial Intelligence Algorithm for the Interpretation of Traumatic Bone Radiographs

NCT07329881 | Active Not Recruiting

• 1 other identifier: AI-Traumat
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trauma (Including Fractures)

Keywords

IA; Validation; Trauma

Outcome Measures

Primary Outcomes (1)

• Diagnostic sensitivity and specificity of the AI algorithm compared to human readers

  Sensitivity and specificity for detection of traumatic bone lesions on radiographs, using the senior physicians' consensus reading as the reference standard (gold standard).

  At the end of image interpretation for each reader (expected within 1 month after image collection).

Study Arms (2)

Residents (human readers)

Residents (human readers)

Artificial Intelligence (AI) algorithm

Artificial Intelligence (AI) algorithm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study Population and Eligibility Criteria Inclusion Criteria: Standard radiographs performed for suspected bone trauma (upper limbs, lower limbs, pelvis/hip, cervical/thoracolumbar spine) in the emergency setting. Adult and pediatric patients (informed consent by patient or legal guardian for minors). Acute trauma context. Exclusion Criteria: Poor-quality images (motion artifact, underexposure preventing diagnostic interpretation). Cases lacking senior interpretation for gold standard reference. Patients referred with radiographs performed outside the hospital (external facilities).

You may qualify if:

• Standard radiographs performed for suspected bone trauma (upper limbs, lower limbs, pelvis/hip, cervical/thoracolumbar spine) in the emergency setting.
• Adult and pediatric patients (informed consent by patient or legal guardian for minors).
• Acute trauma context.

You may not qualify if:

• Poor-quality images (motion artifact, underexposure preventing diagnostic interpretation).
• Cases lacking senior interpretation for gold standard reference.
• Patients referred with radiographs performed outside the hospital (external facilities).

Sponsors & Collaborators

• Hôpital Universitaire Sahloul: lead

Study Sites (1)

CHU sahloul

Sousse, Tunisia

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Riadh boukef, Pr

  Service des urgences CHU Sahloul, Sousse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: November 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 31, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)