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Retrospective clinical study evaluating the safety and effectiveness of the core functions of digital X-ray imaging processing software for scoliosis identification and calculation

Retrospective clinical study evaluating the safety and effectiveness of the core functions of digital X-ray imaging processing software for scoliosis identification and calculation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600124632
Enrollment
Unknown
Registered
2026-05-14
Start date
2026-05-14
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

People with scoliosis

Interventions

Observation group:None

Sponsors

The First Affiliated Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.The adolescent population (aged 10-18) comprises different subgroups with normal, mild, and moderate scoliosis; 2.From 2023 to mid-2025, possess complete full-spine DR images in both frontal and lateral positions, compliant with DICOM standards, with clear and unobstructed images (allowing for the identification of spinal vertebral structures); 3.The medical record information is complete, including basic patient information (gender, age), with no history of spinal-related surgery, no neuromuscular disease, and no severe skeletal developmental abnormalities; 4.Imaging and medical record information can be legally used in clinical trials (with exemption from informed consent approved by the ethics committee).

Exclusion criteria

Exclusion criteria: 1.The image does not comply with the DICOM standard, is blurry, or has severe obstruction in the spinal region, making it impossible to perform segmentation and annotation; 2.The medical record information is incomplete (such as missing key information like age, diagnosis records, surgical history, etc.); 3.Combing spinal tumors, infections, fractures, and other spinal diseases; 4.The imaging technology has been utilized in clinical trials of other similar medical devices.

Design outcomes

Primary

MeasureTime frame
Accuracy of Cobb angle measurement;Keypoint annotation accuracy;Accuracy of spinal region segmentation;

Secondary

MeasureTime frame
Software operation failure rate;data security;

Countries

China

Contacts

Public ContactPan Yuning

The First Affiliated Hospital of Ningbo University

panyuning@163.com+86 137 7714 3231

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026