Clinical trial NCT06754137: Assessing AI-Supported Fracture Detection in Emergency Care Units
Official title: Evaluating the Cost-Efficiency and Workflow Impact of AI-Supported Fracture Detection in an Orthopedic Emergency Care Unit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fractures, Bone
Keywords: Artificial Intelligence
Fracture Detection
Emergency Care
Cost-Efficiency
AI-Assisted Diagnosis
Diagnostic Accuracy
Orthopedic Diagnostics
Lead sponsor: Salzburger Landeskliniken
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 4800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Brief Summary The purpose of this study is to determine if artificial intelligence (AI) can assist doctors in detecting broken bones more quickly and accurately in an emergency room setting. The study will also evaluate whether AI can save time and reduce costs in healthcare.

The main questions to be addressed are:

Does AI improve the accuracy of detecting broken bones? Can AI expedite the process of diagnosing broken bones? Does AI reduce healthcare costs by enhancing efficiency?

To investigate these questions, two groups of patients will be compared. One group will follow the traditional diagnostic approach, while the other group will utilize AI to assist in diagnosing broken bones.

Participants in the study will:

Undergo standard X-ray imaging of injured arms or legs, as part of routine care.

Have X-rays reviewed by doctors with or without AI support, depending on the assigned group.

The study will include patients of all ages presenting to the emergency room with an isolated injury. No additional tests or treatments beyond standard care will be involved.

Detailed description: This clinical trial aims to evaluate the cost-efficiency and workflow impact of AI-assisted fracture detection in an orthopedic emergency care unit. The study is designed as a prospective, randomized, controlled trial to assess whether integrating AI technology can improve diagnostic accuracy, streamline workflow, and reduce healthcare costs compared to the traditional diagnostic approach.

Study Objectives

Primary Objectives:

The primary objective of the SMART Fracture Trial is to assess the impact of AI-assisted fracture detection on physician decision-making and clinical workflows. The study will therefore provide deeper insights into AI's potential benefits and limitations beyond theoretical performance metrics.

Secondary Objectives:

While the primary focus of the SMART Fracture Trial is on AI's clinical integration, the study will also comprehensively assess diagnostic accuracy and fracture classification performance - key factors that influence real-world implementation. By analyzing these secondary objectives, the study will provide deeper insights into AI's theoretical performance metrics.

Study Design

This is a prospective, randomized, controlled trial conducted as an international multi-center study. It includes two parallel arms:

Control Group: Standard diagnostic procedures without AI assistance. Intervention Group: AI-based diagnostic tools assist in interpreting radiological images for fracture detection.

Both groups will follow the same diagnostic imaging protocol, including standard X-ray imaging in two planes. The AI software, pre-validated for fracture detection, will be integrated into the hospital's Picture Archiving and Communication System (PACS).

Intervention Details

The AI fracture detection systems (Aidoc, Gleamer) are designed to identify fracture patterns on X-rays and highlight areas of potential concern for physician review. The software operates in real time, providing marked-up images to physicians. The AI output serves as a diagnostic aid, with final diagnoses made by the attending physician.

Population and Sampling

Population: Patients of all ages presenting to the emergency care unit with suspected isolated extremity fractures.

Sample Size: Approximately 4,800 participants (2400 per group) to ensure sufficient statistical power for primary outcomes.

Randomization: Participants will be randomly assigned to the control or intervention group using a 1:1 allocation ratio.

Outcome Measures

Primary Outcome Measures:

Diagnostic accuracy: Sensitivity, specificity, and AUC of AI-assisted vs. traditional diagnosis.

Time to diagnosis: Total time from patient triage to final diagnosis.

Secondary Outcome Measures:

Cost analysis: A detailed cost comparison of the diagnostic process in both groups.

Diagnostic confidence: Assessed using a Likert scale (1-10) completed by physicians after reviewing each case.

Study Procedures

Baseline Data Collection: Demographics, clinical history, and presenting symptoms will be recorded at enrollment. Standard radiological imaging will be conducted for all participants.

AI Integration (Intervention Group): Radiological images will be processed by AI software, providing annotated images to physicians. AI-assisted diagnostic workflows will be compared to standard workflows.

Outcome Assessment: All diagnoses will be independently reviewed by a panel of experts, including an experienced radiologist and orthopedic surgeon, to establish a reference standard for comparison.

Ethical Considerations

The study adheres to the principles of the Declaration of Helsinki and has received approval from the local ethics committee. Written informed consent will be obtained from all participants before enrollment. Data will be pseudonymized to maintain confidentiality.

Expected Impact

This study aims to provide robust evidence regarding the effectiveness of AI in improving diagnostic workflows in emergency care settings. Findings may inform the future integration of AI tools into clinical practice, improving patient outcomes and optimizing resource utilization in high-volume emergency care environments.

Eligibility criteria: Inclusion Criteria:

* Presenting to the emergency department with a suspected isolated fracture
* Patients able and willing to provide informed consent.

Exclusion Criteria:

* Polytrauma patients with injuries involving multiple body regions
* Patients with prior imaging of the affected extremity within the past 6 months
* Contraindications to X-ray imaging (e.g., pregnancy or severe instability)
* Patients with other ongoing studies that may interfere with this study
* Patients unable to provide consent due to cognitive impairment or language barriers without an available representative.

Primary outcomes:
measure: Diagnostic Accuracy of Fracture Detection
timeFrame: At the time of initial diagnosis, within 2 hours of patient presentation to the orthopedic emergency unit
Secondary outcomes:
measure: Time to Diagnosis
timeFrame: During the patient's emergency department visit, typically within 4 hours of presentation.
measure: Physician Diagnostic Confidence
timeFrame: Measured immediately after the diagnosis
measure: Cost-Efficiency of Diagnostic Workflow
timeFrame: Calculated at the end of the study for all enrolled participants, approximately 6 months from study initiation.
Other outcomes:
Locations:
city: Hallein
country: Austria
facility: Landesklinik Hallein, Salzburger Landeskliniken
city: Salzburg
country: Austria
facility: University Hospital Salzburg, Salzburger Landeskliniken
city: Nuremberg
country: Germany
facility: University Hosptial Nuremberg, Klinikum Nürnberg
Study officials:
References: