ClinicalTrials.gg
RecruitingNCT05146193Updated May 1, 2026

AI-Powered Scoliosis Auto-Analysis System Multicenter Development and Validations

An observational study in Spinal Deformity, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 10 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-01.

Primary conditionScoliosisRegistry: Congenital AbnormalitiesReclassifiedWhy we changed it
Registry
Congenital Abnormalities — the first condition term the registry derived for this study.
ClinicalTrials.gg
Scoliosis
Why
  1. Congenital Abnormalities is a broad heading, used only when no more specific condition is named.
  2. The study's title name Scoliosis.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by The University of Hong Kong · Observational

From the registry’s dates

  • Started May 2022; still recruiting 4 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,500
Ages
10 Years to 80 Years
Sex
All
01

Study summary

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:

  1. 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.
  2. 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).
  3. Use transfer learning to update the current AlignProCARE for scoliosis analysis to form AlignProCARE+.

4 Qualitatively analyse the AlignProCARE+ using an independent dataset.

02

Conditions studied

  • Spinal Deformity

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Keywords

  • Adult deformity, scoliosis, spondylolisthesis
03

In context

Scoliosis Reclassified

660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 84 across 256 observational studies indexed under Scoliosis.

Browse Scoliosis studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Scoliosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Congenital Abnormalities. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
10 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All subjects with spinal deformities

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Idiopathic scoliosis, adult deformity (spondylolisthesis, idiopathic kyphosis, kyphoscoliosis, lordoscoliosis)

Exclusion criteria

Exclusion Criteria:

  • Refusal for imaging, postoperative patients
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • All subjects are diagnosed of having a spinal deformity

    Routine care of patients with spinal deformities

    Other: Nude back photo

Interventions

  • OtherNude back photo

    Nude back photo at baseline and at follow-ups for each patient and visual severity and curve type classifications

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

Secondary outcomes

  1. Thoracic kyphosis

    Thoracic kyphosis T5-12: angle between upper endplate of T5 to lower endplate of T12 in the lateral radiograph

    Time frame: 1 year

  2. Lumbar lordosis

    Lumbar lordosis L1-S1: angle between upper endplate of L1 to top of S1 in the lateral radiograph

    Time frame: 1 year

  3. Pelvic tilt

    Pelvic tilt angle measurement in degrees in the lateral radiograph

    Time frame: 1 year

  4. Sacral slope

    Sacral slope angle measurement in degrees in the lateral radiograph

    Time frame: 1 year

  5. Pelvic incidence

    Pelvic incidence angle measurement in degrees in the lateral radiograph

    Time frame: 1 year

  6. 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

    Time frame: 1 year

  7. Curve severity

    Severity classifications: normal-mild; moderate and severe

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05146193
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
Dr. Jason Pui Yin Cheung (Clinical Associate Professor, The University of Hong Kong) — Principal investigator
First posted
Dec 6, 2021
Start date
May 1, 2022
Primary completion
Feb 1, 2029 (estimated)
Completion
Feb 1, 2030 (estimated)
Last update
May 1, 2026

Study contacts

Jason Pui Yin Cheung, MD, MS
Contact
cheungjp@hku.hk
(852) 22554254
Teng Zhang, PhD
Contact
tgzhang@hku.hk
(852) 22554254
Jason Pui Yin Cheung, MD, MS
principal investigator · Queen Mary Hospital, Duchess of Kent Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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