Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510049
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-30
Brief Title:
Validity and Reliability of Ultrasound Imaging for Measuring Coronal and Sagittal Angles in Idiopathic Scoliosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validity and Reliability of Ultrasound Imaging for Measuring Coronal and Sagittal Angles in Idiopathic Scoliosis
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Cobbs angle Thoracic Kyphosis TK and Lumbar Lordosis LL
Detailed Description:
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 monitoredFor comprehensive analysis participants were systematically categorized based on multiple demographic and clinical parameters coronal angle either 20 or 20 gender male or female age either14 years or 14 years and nutritional status classified as normal or abnormal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None