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Completed

NCT Number: NCT06510049

Validity and Reliability of Ultrasound Imaging for Measuring Coronal and Sagittal Angles in Idiopathic Scoliosis

Patients with idiopathic scoliosis (IS), especially children and adolescents, require regular follow-up evaluations. Ultrasound imaging offers a reliable, radiation-free method for assessing spinal curvatures in the coronal and sagittal planes. While manual labeling in traditional ultrasound is error-prone, automated labeling reduces inaccuracies but still needs further validation, particularly in the sagittal plane. This study compared three-dimensional (3D) ultrasound assessments with conventional X-ray images--the clinical gold standard. And it is aimed to evaluate the validity and reliability of ultrasound measurements-Ultrasound Curve Angle (UCA) and Ultrasound Lamellar Angle (USLA)-against established radiographic benchmarks like Cobb's angle, Thoracic Kyphosis (TK), and Lumbar Lordosis (LL).

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine (Zhejiang Provincial Hospital of Traditional Chinese Medicine)

Hangzhou, Zhejiang, 310016, China

About this study

This study was structured into two fundamental segments: 1) a dual-operator analysis focused on evaluating both intra- and inter-operator reliability of the UCA and USLA; and 2) a validation study of radiographic indices, specifically the coronal Cobb angle, TK, and LL, in correlation with UCA and USLA measurements. Initially, 100 patients diagnosed with IS were subjected to both standard radiographic and 3D ultrasound examinations. Owing to various exclusion criteria, 20 patients were subsequently disqualified from the study, resulting in a final sample of 80 patients for statistical evaluation. Reliability assessments were conducted using the Intraclass Correlation Coefficient (ICC). Furthermore, the validity of the UCA and USLA measurements was rigorously analyzed by comparing them against established radiographic benchmarks, utilizing Pearson correlation coefficients and Bland-Altman plots for comprehensive evaluation. All expected or unexpected adverse events from this study will be recorded and monitored.For comprehensive analysis, participants were systematically categorized based on multiple demographic and clinical parameters: coronal angle (either ≥20° or <20°), gender (male or female), age (either>14 years or ≤14 years), and nutritional status (classified as normal or abnormal).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with IS who were cooperative with ultrasound procedures.

Exclusion criteria

  • Patients with spinal disorders such as Marfan's syndrome, a history of ankylosing spondylitis, or spinal neurofibroma.
  • Patients with severe medical or psychiatric conditions that could potentially impact the study results.

Treatment and study plan

Primary outcomes

  1. Coronal thorax/thoracolumbar/lumbar cobb angle and sagittal thorax/thoracomaxillary/lumbar anterior and posterior lordosis angles on x-ray

    Time frame: January to May 2024

    Coronal thorax/thoracolumbar/lumbar cobb angle and sagittal thorax/thoracomaxillary/lumbar anterior and posterior lordosis angles on x-ray

  2. Coronal thoracic/thoracolumbar/lumbar cobb angle and sagittal thoracic/thoracomaxillary/lumbar anterior-posterior lordosis angle on ultrasound

    Time frame: January to May 2024

    Coronal thoracic/thoracolumbar/lumbar cobb angle and sagittal thoracic/thoracomaxillary/lumbar anterior-posterior lordosis angle on ultrasound

Secondary outcomes

  1. gender

    Time frame: January to May 2024

    gender

  2. age

    Time frame: January to May 2024

    age

  3. BMI

    Time frame: January to May 2024

    BMI

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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