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Artificial Intelligence Diagnosis of Spinal Osteoporotic Fractures Assisted by X-rays: A Multi Center Prospective Diagnostic Trial Study

Artificial Intelligence Diagnosis of Spinal Osteoporotic Fractures Assisted by X-rays: A Multi Center Prospective Diagnostic Trial Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500104748
Enrollment
Unknown
Registered
2025-06-23
Start date
2025-07-01
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Spinal osteoporotic fracture

Interventions

Gold Standard:(1) X-rays, CT scans, and MRI all indicate spinal compression fractures
(2) DXA measurement shows that the T-value of the lumbar spine or hip joint is less than -2.5
(3) MRI T2WI compression fat image with high signal intensity suggests fresh spinal compression fracture.
Index test:Artificial Intelligence Diagnosis System for Spinal Osteoporotic Fractures Assisted by X-rays

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Women who have reached menopause or men who are >= 60 years old; (2) History of trauma and duration less than 3 months; (3) X-rays, CT scans, and MRI all indicate spinal compression fractures; (4) DXA measurement shows that the T-value of the lumbar spine or hip joint is less than -2.5; (5) MRI T2WI compression fat image with high signal intensity suggests fresh spinal compression fracture; (6) The patient underwent surgical treatment and provided informed consent.

Exclusion criteria

Exclusion criteria: (1) The patient has a history of cancer or is suspected of having a history of cancer; (2) Spinal burst fracture, with or without symptoms of spinal cord injury.

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of X-ray diagnosis of osteoporosis and freshness of osteoporotic fractures.;

Countries

China

Contacts

Public ContactFei Yu

Shenzhen Second People's Hospital

yufei89@pku.edu.cn+86 158 0755 5534

Outcome results

None listed

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