Adolscent Idiopathic ScoliosisNCT07490886
Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure
An observational study of Adolscent Idiopathic Scoliosis, run by Joint Scoliosis Research Center of the Chinese University of Hong Kong and Nanjing University at 1 site in Hong Kong.
Trial summary
Introduction Scoliosis is a three dimensional spinal deformity, in the coronal plane, sagittal and transverse planes. The conventional method for assessment of severity of scoliosis is by measuring the Cobb angle on x-ray radiographs of the whole spine. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Adolscent Idiopathic Scoliosis
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- 4 Nov 2025to 31 Aug 2026
- 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: children referred for scoliosis screening
Who may be able to join
- referred for scoliosis screening
Who cannot join
- extreme body stature
Trial locations and contacts
1 site in 1 country.
About this study
Introduction Scoliosis is a three dimensional spinal deformity, in the coronal plane, sagittal and transverse planes. The conventional method for assessment of severity of scoliosis is by measuring the Cobb angle on x-ray radiographs of the whole spine. The drawback with x-ray radiography is that it involves radiation. In light of this, a radiation-free ultrasound imaging system, the Scolioscan, has been developed for quantitative assessment of spinal deformity.
This study aims at evaluating the effectiveness of Scolioscan for screening scoliosis among school children in Hong Kong.
Read more
Benefit and harm The results of this study will carry significant impacts in that if Scolioscan is proven to be accurate for screening scoliosis among school children, it can be incorporated in the algorithm for screening scoliosis with the intention of reducing unnecessary x-ray exposure.
Scolioscan is a radiation-free ultrasound system.
Procedures
- This is a longitudinal study on school children screened for scoliosis at the Student Health Service Centres of Department of Health. If the subject and the guardians agree to participate in the study, ultrasound scanning of the spine using the Scolioscan will be performed. No additional visit is required beyond the routine practice. Clinical assessment of apical rotation of the spine with the subjects bending forward will also be measured using a Scoliometer at the first clinic visit and subsequent clinic follow- up visits at Prince of Wales Hospital. Specialist care for the back problem and scoliosis will be continued at Prince of Wales Hospital as needed.
- Subjects will be identified at the Student Health Service Centres of Department of Health, Hong Kong. Those who fulfill the recruitment criteria and their guardians will be given full explanation of the study and be invited to participate in the study.
During the scanning procedure with the Scolioscan, clients will be asked to stand steadily in different postures, namely erect, right side-bending and left side-bending within the comfort level of the clients. Ultrasound gel will be applied on the back and ultrasound images will be taken along the spine. The scanning itself may last for 1 minute for each posture.
- Conditions
- Adolscent Idiopathic Scoliosis
- Keywords
- Adolscent idiopathic scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound positive | ultrasound positive | |
| ultrasound negative | ultrasound negative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of ultrasound in detecting cases with a radiological cobb angle of more than 20 degrees
Both ultrasound and EOS radiographs will be performed for the participant on the same day. Two by two table will be constructed for calculation of the sensitivity, specificity, positive predictive value, negative predictive value on whether ultrasound could detect cases with radiological cobb angle of more than 20 degrees.
Measured: Baseline
Secondary outcomes (1)
Cobb angle progression
Cobb angle on follow-up will be measured with EOS radiographs
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start4 Nov 2025
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolscent Idiopathic ScoliosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joint Scoliosis Research Center of the Chinese University of Hong Kong and Nanjing University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Principal investigator, Kwan Cheuk Kin, Joint Scoliosis Research Center of the Chinese University of Hong Kong and Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490886
- Sponsor's protocol ID
- 001
- Other IDs
- 2025-391-T
- Status last verified
- Sep 2026
- First submitted
- 29 Dec 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing is not required to fulfill the goal of the study.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure
- ClinicalTrials.gov ID
- NCT07490886
- Acronym / sponsor ID
- 001
- Conditions
- Adolscent Idiopathic Scoliosis
- Keywords
- Adolscent idiopathic scoliosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Joint Scoliosis Research Center of the Chinese University of Hong Kong and Nanjing UniversityUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 24 Mar 2026 (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.
Introduction Scoliosis is a three dimensional spinal deformity, in the coronal plane, sagittal and transverse planes. The conventional method for assessment of severity of scoliosis is by measuring the Cobb angle on x-ray radiographs of the whole spine. The drawback with x-ray radiography is that it involves radiation. In light of this, a radiation-free ultrasound imaging system, the Scolioscan, has been developed for quantitative assessment of spinal deformity.
This study aims at evaluating the effectiveness of Scolioscan for screening scoliosis among school children in Hong Kong.
Benefit and harm The results of this study will carry significant impacts in that if Scolioscan is proven to be accurate for screening scoliosis among school children, it can be incorporated in the algorithm for screening scoliosis with the intention of reducing unnecessary x-ray exposure.
Scolioscan is a radiation-free ultrasound system.
Procedures
- This is a longitudinal study on school children screened for scoliosis at the Student Health Service Centres of Department of Health. If the subject and the guardians agree to participate in the study, ultrasound scanning of the spine using the Scolioscan will be performed. No additional visit is required beyond the routine practice. Clinical assessment of apical rotation of the spine with the subjects bending forward will also be measured using a Scoliometer at the first clinic visit and subsequent clinic follow- up visits at Prince of Wales Hospital. Specialist care for the back problem and scoliosis will be continued at Prince of Wales Hospital as needed.
- Subjects will be identified at the Student Health Service Centres of Department of Health, Hong Kong. Those who fulfill the recruitment criteria and their guardians will be given full explanation of the study and be invited to participate in the study.
During the scanning procedure with the Scolioscan, clients will be asked to stand steadily in different postures, namely erect, right side-bending and left side-bending within the comfort level of the clients. Ultrasound gel will be applied on the back and ultrasound images will be taken along the spine. The scanning itself may last for 1 minute for each posture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound positive | – | –ultrasound positive |
| ultrasound negative | – | –ultrasound negative |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- children referred for scoliosis screening
Key inclusion criteria (1 listed)
- referred for scoliosis screening
Key exclusion criteria (1 listed)
- extreme body stature
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
Accuracy of ultrasound in detecting cases with a radiological cobb angle of more than 20 degrees
Time frame: Baseline
Both ultrasound and EOS radiographs will be performed for the participant on the same day. Two by two table will be constructed for calculation of the sensitivity, specificity, positive predictive value, negative predictive value on whether ultrasound could detect cases with radiological cobb angle of more than 20 degrees.
1 secondary outcome
Cobb angle progression
Time frame: 1 year
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 16 Sep 2026.
- Individual participant dataSharing planned: No. Data sharing is not required to fulfill the goal of the study.
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 Adolscent Idiopathic Scoliosis, run by Joint Scoliosis Research Center of the Chinese University of Hong Kong and Nanjing University at 1 site in Hong Kong.
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 1 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 16 Sep 2026. 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 Hong Kong. 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?
Accuracy of ultrasound in detecting cases with a radiological cobb angle of more than 20 degrees (time frame: Baseline). 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 16 Sep 2026.