Spinal DeformityNCT05146193
AI-Powered Scoliosis Auto-Analysis System Multicenter Development and Validations
An observational study of Spinal Deformity, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The investigators aim to use artificial intelligence (AI) to help clinicians in diagnosing and assessing spinal deformities. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Spinal Deformity
- What is being tested?
- Nude back photo
- How many people
- 2,500 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2022to 1 Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 10 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: All subjects with spinal deformities
Who may be able to join
- Idiopathic scoliosis, adult deformity (spondylolisthesis, idiopathic kyphosis, kyphoscoliosis, lordoscoliosis)
Who cannot join
- Refusal for imaging, postoperative patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Duchess of Kent Children's Hospital
Hong Kong
Jason Cheung, 85222554581 ext. 85222554581, cheungjp@hku.hk
About this study
The investigators aim to use artificial intelligence (AI) to help clinicians in diagnosing and assessing spinal deformities.
Read the detailed description
Background Spinal deformity is a prevalent spinal disorder in both paediatric and adult populations. The spine alignment need to be quantitively assessed for further treatment planning. However, the current practice requires spine surgeons to manually place landmarks of endplates and key vertebrae. The process is laborious and prone to inter- and intra-rater variance. Thus, the investigators have developed an AI-powered spine alignment assessment system (AlignProCARE) to facilitate clinicians in fast, accurate and consistent analytical results.
The investigators aim to test and improve the performance of the spine alignment auto-analysis in all patients with spinal deformities in multiple centers including Malaysia, China, and Japan
Objectives:
- prospectively test the alignment assessment of patients' spinal deformities with whole spine X-rays (both PA and lateral) and nude back image with the assessment via AlignProCARE.
- Collect 500 labeled deformity radiographs and nude back images in both PA and lateral views per center. 150 patients need to be followed up with radiographs and nude back photos collected (all parameters measured again).
- Use transfer learning to update the current AlignProCARE for scoliosis analysis to form AlignProCARE+.
4 Qualitatively analyse the AlignProCARE+ using an independent dataset.
- Conditions
- Spinal Deformity
- Being tested
- Nude back photo
- Keywords
- Adult deformity, scoliosis, spondylolisthesis
- Medical subject headings
- Congenital Abnormalities, Scoliosis, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nude back photoOther
Nude back photo at baseline and at follow-ups for each patient and visual severity and curve type classifications
| Study group | Role | What they receive |
|---|---|---|
| All subjects are diagnosed of having a spinal deformity | Routine care of patients with spinal deformities Receives: Other: Nude back photo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb angle
Coronal Cobb angle of the spinal deformity. The most tilted end vertebrae away from the apex will be used for measurement of the Cobb angle.The anteroposterior radiograph is used to assess
Measured: 1 year
Secondary outcomes (7)
Thoracic kyphosis
Thoracic kyphosis T5-12: angle between upper endplate of T5 to lower endplate of T12 in the lateral radiograph
Measured: 1 year
Lumbar lordosis
Lumbar lordosis L1-S1: angle between upper endplate of L1 to top of S1 in the lateral radiograph
Measured: 1 year
Pelvic tilt
Pelvic tilt angle measurement in degrees in the lateral radiograph
Measured: 1 year
Sacral slope
Sacral slope angle measurement in degrees in the lateral radiograph
Measured: 1 year
Pelvic incidence
Pelvic incidence angle measurement in degrees in the lateral radiograph
Measured: 1 year
Maximum thoracic kyphosis
Maximum thoracic kyphosis: angle measurement from the upper endplate of most tilted upper end vertebra to the lower endplate of the lower end vertebra of the thoracic spine in the sagittal plane radiograph
Measured: 1 year
Curve severity
Severity classifications: normal-mild; moderate and severe
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 posted6 Dec 2021
- Study start1 May 2022
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DeformityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College, Peking University Third Hospital, Beijing Chao Yang Hospital, University of Malaya, Nara Medical University, Hamamatsu University, Ruijin Hospital, Huashan Hospital, Zhejiang University, Ji Shui Tan Hospital
- Responsible party
- Principal investigator, Dr. Jason Pui Yin Cheung, The University of Hong Kong
- Investigators
- Jason Pui Yin Cheung, MD, MS, Principal investigator, Queen Mary Hospital, Duchess of Kent Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146193
- Sponsor's protocol ID
- AI_Scoliosis
- Status last verified
- Apr 2026
- First submitted
- 12 Nov 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- 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 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Powered Scoliosis Auto-Analysis System Multicenter Development and Validations
- ClinicalTrials.gov ID
- NCT05146193
- Acronym / sponsor ID
- AI_Scoliosis
- Conditions
- Spinal Deformity
- Keywords
- Adult deformity, scoliosis, spondylolisthesis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Peking Union Medical College, Peking University Third Hospital, Beijing Chao Yang Hospital, University of Malaya, Nara Medical University, Hamamatsu University, Ruijin Hospital, Huashan Hospital, Zhejiang University, Ji Shui Tan Hospital
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 6 Dec 2021 (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.
The investigators aim to use artificial intelligence (AI) to help clinicians in diagnosing and assessing spinal deformities.
Detailed description
Background Spinal deformity is a prevalent spinal disorder in both paediatric and adult populations. The spine alignment need to be quantitively assessed for further treatment planning. However, the current practice requires spine surgeons to manually place landmarks of endplates and key vertebrae. The process is laborious and prone to inter- and intra-rater variance. Thus, the investigators have developed an AI-powered spine alignment assessment system (AlignProCARE) to facilitate clinicians in fast, accurate and consistent analytical results.
The investigators aim to test and improve the performance of the spine alignment auto-analysis in all patients with spinal deformities in multiple centers including Malaysia, China, and Japan
Objectives:
- prospectively test the alignment assessment of patients' spinal deformities with whole spine X-rays (both PA and lateral) and nude back image with the assessment via AlignProCARE.
- Collect 500 labeled deformity radiographs and nude back images in both PA and lateral views per center. 150 patients need to be followed up with radiographs and nude back photos collected (all parameters measured again).
- Use transfer learning to update the current AlignProCARE for scoliosis analysis to form AlignProCARE+.
4 Qualitatively analyse the AlignProCARE+ using an independent dataset.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects are diagnosed of having a spinal deformity | – | Other: Nude back photoRoutine care of patients with spinal deformities |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All subjects with spinal deformities
Key inclusion criteria (1 listed)
- Idiopathic scoliosis, adult deformity (spondylolisthesis, idiopathic kyphosis, kyphoscoliosis, lordoscoliosis)
Key exclusion criteria (1 listed)
- Refusal for imaging, postoperative patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nude back photoNude back photo at baseline and at follow-ups for each patient and visual severity and curve type classifications | Other | All subjects are diagnosed of having a spinal deformity |
Primary outcome
Cobb angle
Time frame: 1 year
Coronal Cobb angle of the spinal deformity. The most tilted end vertebrae away from the apex will be used for measurement of the Cobb angle.The anteroposterior radiograph is used to assess
7 secondary outcomes
Thoracic kyphosis
Time frame: 1 year
Lumbar lordosis
Time frame: 1 year
Pelvic tilt
Time frame: 1 year
Sacral slope
Time frame: 1 year
Pelvic incidence
Time frame: 1 year
Maximum thoracic kyphosis
Time frame: 1 year
Curve severity
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- 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.
Jason Pui Yin Cheung, MD, MS principal investigator
Queen Mary Hospital, Duchess of Kent Children's Hospital
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 Spinal Deformity, run by The University of Hong Kong 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: looking for participants now, as of the sponsor's last update on 1 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason Pui Yin Cheung, MD, MS ((852) 22554254, cheungjp@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb angle (time frame: 1 year). 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 1 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.