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Multicenter clinical trial on the accuracy and repeatability of a 3D ultrasound scoliosis assessment system for evaluating adolescent idiopathic scoliosis

Multicenter clinical trial on the accuracy and repeatability of a 3D ultrasound scoliosis assessment system for evaluating adolescent idiopathic scoliosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600124784
Enrollment
Unknown
Registered
2026-05-18
Start date
2024-07-02
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

Adolescent idiopathic scoliosis

Interventions

Gold Standard:Radiographic X-ray measurement of Cobb angle is the gold standard for evaluating scoliosis
Index test:The experimental instrument used in this study is the Scolioscan system (which has been approved for Class II medical device certification)

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. suspected AIS patients who are scheduled to undergo spinal X-ray examination; 2. Clear minded and able to communicate clearly; 3. Age >= 10 years old and <= 18 years old, regardless of gender; 4.BMI<=25kg/m^2; 5. The subjects and their guardians (or their guardians) voluntarily participate in this clinical trial and have signed a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. expected X-ray Cobb angle>60 °; 2. Wear pacemakers, implantable pain relievers, insulin delivery systems, defibrillators, or other ferromagnetic implants; 3. Merge other serious diseases in various systems; 4. History of fainting within one year; 5. Combination of mental illness or inability to cooperate with examination for other illnesses; 6. The researchers believe that it is not appropriate to participate in this clinical trial. Note: If the lateral curvature is S-shaped, measure one angle each for the chest and waist segments; When analyzing, if any angle is greater than or equal to 10 degrees, the corresponding X-ray Cobb angle or ultrasound UCA will be used for comparison; If both the X-ray Cobb angle and ultrasound UCA are less than 10 degrees, they will not be included in the analysis.

Design outcomes

Primary

MeasureTime frame
Consistency of experimental equipment and X-ray examination in evaluating various curvatures of scoliosis;

Secondary

MeasureTime frame
Compare the measurement results of the first and second inspections of the experimental equipment to evaluate its repeatability.;

Countries

China

Contacts

Public ContactHaiying Liu

Peking University People's Hospital

xushuairmyy@pku.edu.cn+86 188 1179 2718

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026