UltrasonographyNCT06510049
Validity and Reliability of Ultrasound Imaging for Measuring Coronal and Sagittal Angles in Idiopathic Scoliosis
An observational study of Ultrasonography and Coronal, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ultrasonography, Coronal, Sagittal
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2024to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with IS who were cooperative with ultrasound procedures.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine (Zhejiang Provincial Hospital of Traditional Chinese Medicine)
Hangzhou, Zhejiang, 310016
About this study
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).
Read the 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).
- Conditions
- Ultrasonography, Coronal, Sagittal, Idiopathic Scoliosis, Validation Studies as Topic, Program Evaluation
- Keywords
- Ultrasonography, Coronal, Sagittal, Idiopathic Scoliosis, Reliability, Validity
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronal thorax/thoracolumbar/lumbar cobb angle and sagittal thorax/thoracomaxillary/lumbar anterior and posterior lordosis angles on x-ray
Coronal thorax/thoracolumbar/lumbar cobb angle and sagittal thorax/thoracomaxillary/lumbar anterior and posterior lordosis angles on x-ray
Measured: January to May 2024
Coronal thoracic/thoracolumbar/lumbar cobb angle and sagittal thoracic/thoracomaxillary/lumbar anterior-posterior lordosis angle on ultrasound
Coronal thoracic/thoracolumbar/lumbar cobb angle and sagittal thoracic/thoracomaxillary/lumbar anterior-posterior lordosis angle on ultrasound
Measured: January to May 2024
Secondary outcomes (3)
gender
gender
Measured: January to May 2024
age
age
Measured: January to May 2024
BMI
BMI
Measured: January to May 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start22 Jan 2024
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510049
- Sponsor's protocol ID
- 2024-KS-467-01
- Status last verified
- Jul 2024
- First submitted
- 30 Jun 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Ultrasound Imaging for Measuring Coronal and Sagittal Angles in Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06510049
- Acronym / sponsor ID
- 2024-KS-467-01
- Conditions
- Ultrasonography, Coronal, Sagittal, Idiopathic Scoliosis, Validation Studies as Topic, Program Evaluation
- Keywords
- Ultrasonography, Coronal, Sagittal, Idiopathic Scoliosis, Reliability, Validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with IS who were cooperative with ultrasound procedures.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
3 secondary outcomes
gender
Time frame: January to May 2024
age
Time frame: January to May 2024
BMI
Time frame: January to May 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasonography and Coronal, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.