Clinical Trials Logo

Clinical Trial Summary

Limb fracture is a common pathology in children. It represents the first complaint in traumatology among children in developed countries. Failure to diagnose a fracture can have severe consequences in pediatric patients with growing bones, that can lead to delayed treatment, pain and poor functional recovery. X-ray is the first tool used by doctors to diagnose a fracture. However, the diagnosis of fracture in the emergency room can be challenging. Most images are interpreted and processed by emergency pediatricians before being reviewed by radiologists (most often the day after). Previous studies have reported the rate of misdiagnosis in fracture by emergency physicians from 5% to 15%. A tool to investigate in diagnosing limb fractures could be helpful for any emergency physicians exposed to this condition


Clinical Trial Description

Limb fracture is a common pathology in children with trauma. It represents the first complaint in traumatology among children in developed countries. Failure to diagnose a fracture on an X-ray can have severe consequences in pediatric patients, with growing bones, that can lead to delayed treatment, pain and poor functional recovery (with risk of bone deformity and bad consolidation). X-ray is the first tool used by doctors to diagnose a fracture. However, the diagnosis of fracture in the emergency room can be challenging. Most images are interpreted and processed by both residents and pediatricians before the radiologists proofread (most often the day after). Previous studies have reported the rate of misdiagnosis in fracture by emergency physicians from 5 to 15%. A tool to investigate in diagnosing limb fractures could be helpful for any clinician exposed to this condition. Artificial intelligence (AI) in medicine is booming and has already proven its worth, in terms of prevention, monitoring and diagnosis. AZMED has created RAYVOLVE®, a deep learning algorithm to help physicians in diagnosing fractures. The RAYVOLVE® tool connects to the PACS (Picture Archiving and Communication System) of any hospital and indicates, using a frame, the location of a potential fracture. The tool has not yet been validated in pediatric patients. The purpose of this research project is to evaluate the contribution of this artificial intelligence-based tool in the diagnosis of limb fracture in pediatric population. The investigators will study the concordance in diagnosing limb fracture between the junior emergency physicians using the RAYVOLVE® application and senior radiologists, as the gold standard. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05187585
Study type Interventional
Source Fondation Lenval
Contact MARCO OLLA, MD
Phone 049203 0442
Email olla.m@pediatrie-chulenval-nice.fr
Status Recruiting
Phase N/A
Start date February 10, 2022
Completion date October 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05555459 - Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation N/A
Completed NCT03147222 - Function Focused Care: Fracture Care at Home N/A
Completed NCT03506958 - Patient Satisfaction in Treatment of Non-complex Fractures and Dislocations in Hospitals vs General Practitioners
Completed NCT04426981 - Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study N/A
Recruiting NCT04389749 - Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures N/A
Recruiting NCT05068180 - Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients Phase 4
Recruiting NCT05594199 - Feasibility of a Virtual Smoking Cessation Program N/A
Completed NCT04514601 - A Quality Improvement Project to Assess and Refine the Handover Process at Morning Trauma Meetings
Completed NCT05138640 - Bone Strength and Physical Activity in Patients With a Recent Clinical Fracture
Completed NCT02272972 - Performance Improvement Program on Imaging II
Completed NCT04215315 - Fracture In Preterm Infants Study (FIPIN Study)
Completed NCT03219125 - Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women
Terminated NCT05655130 - Distal Radius Steroid Phase 1
Completed NCT04151732 - Factors Associated With Future Fractures in Middle-aged Men and Women
Completed NCT02714257 - Working to Increase Stability Through Exercise N/A
Completed NCT02428244 - Let's STOP Now Trial: Smoking in Trauma Orthopaedic Patients N/A
Recruiting NCT04501510 - Ultrasonography in Fracture Management
Completed NCT03852095 - Single Time Management Diseases in Pediatric Traumatology
Completed NCT04440631 - Gut Microbiome of Patients Undergoing Antibiotic Therapy for Orthopedic Device-related Infection
Completed NCT03370900 - Learning Retention in Radiograph Interpretation N/A