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

July 18, 2024 updated by: The First Affiliated Hospital of Zhejiang Chinese Medical University
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine (Zhejiang Provincial Hospital of Traditional Chinese Medicine)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients diagnosed with IS who have been admitted to the Scoliosis Traditional Chinese and Western Medicine Diagnosis and Treatment Center of Zhejiang Provincial Hospital of Traditional Chinese Medicine since May 2023.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
January to May 2024
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
January to May 2024

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
gender
Time Frame: January to May 2024
gender
January to May 2024
age
Time Frame: January to May 2024
age
January to May 2024
BMI
Time Frame: January to May 2024
BMI
January to May 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital of Zhejiang Chinese Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-KS-467-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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