Skip to content

Accuracy of Artificial Intelligence to diagnose vertebral fracture based on X-ray images

Accuracy of Artificial Intelligence to diagnose vertebral fracture based on X-ray images

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400091172
Enrollment
Unknown
Registered
2024-10-22
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporotic vertebral fractures

Interventions

Gold Standard:Vertebral X-ray scan indicates the presence of pyramidal fractures
Index test:Artificial intelligence automated diagnosis system for lumbar spine fractures

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1: Aged >=18 years and <= 85 years old. 2: Subjects who undergo vertebral X-ray scanning in our hospital and have a diagnosis report by two or more radiology experts.The qualification standards for radiology experts include the following conditions: (1) having a professional practicing physician qualification certificate in imaging, (2) having at least intermediate or senior professional technical titles, (3) having the qualification to independently conduct imaging examinations and diagnoses, proficient in the principles, methods, operations, and report writing norms of various imaging examinations. 3: Providing demographic information and personal medical history. Demographic information and personal medical history include age, gender, height, weight, etc. 4: The image data must meet the analysis quality requirements and be free from factors such as blurring, overexposure, ghosting, or artifacts that may affect the judgment.

Exclusion criteria

Exclusion criteria: 1: Age85 years old, or pregnant. 2: Artificial implants appear in the image. 3: Poor image quality, such as blurring, overexposure, ghosting, or artifacts, can affect the judgment. 4: Weight exceeding 100 kilograms or height exceeding 2 meters. 5: Had an X-ray scan and taken contrast agents within the last 7 days prior to this scan.

Design outcomes

Primary

MeasureTime frame
sensitivity;Specificity;Positive Predictive Value, PPV;Negative Predictive Value, NPV;Receiver Operating Characteristic Curve, ROC Curve;Area Under the ROC Curve, AUC;

Countries

China

Contacts

Public ContactXin Gao

Zhongshan Hospital, Fudan University

happy20061208@126.com+86 138 1782 2597

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026