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A multicenter, randomized, parallel controlled clinical trial evaluating the effectiveness and safety of intelligent X-ray Auxiliary Software for Assisting in the Diagnosis of Osteoporotic Vertebral Compression Fractures

A multicenter, randomized, parallel controlled clinical trial evaluating the effectiveness and safety of intelligent X-ray Auxiliary Software for Assisting in the Diagnosis of Osteoporotic Vertebral Compression Fractures

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400088191
Enrollment
Unknown
Registered
2024-08-13
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-08-19

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:Two senior radiologists (with advanced professional titles and over 10 years of work experience) independently and separately review the images. They use the Genant visual semi-quantitat
Index test:Intelligent Assistive Software for X-ray Osteoporotic Vertebral Compression Fractures

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) The X-rays are from subjects aged 60 years or older, regardless of gender. (2) The X-rays are from patients who underwent thoracic and/or lumbar spine X-ray examinations. (3) The X-ray examinations were conducted between June 2023 and June 2024.

Exclusion criteria

Exclusion criteria: (1) The sample-related information (e.g., gender, age, vertebral-related medical history, etc.) is incomplete and cannot be traced. (2) The image quality is substandard, such as being blurry, overexposed, having ghosting or artifacts, etc. (3) The image shows prosthetic joints or implants. (4) The image shows screw fixation. (5) Samples deemed unsuitable for participation in this trial by the researchers.

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;

Secondary

MeasureTime frame
accuracy;Reading time;Performance Evaluation of the Device;Kappa value;

Countries

China

Contacts

Public ContactZhenlin Zhang; Qingcheng Yang

Shanghai Sixth People's Hospital

zhangzl@sjtu.edu.cn+86 136 2167 3716

Outcome results

None listed

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