Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05146193
Enrollment
2500
Registered
2021-12-06
Start date
2022-05-01
Completion date
2030-02-01
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Deformity

Keywords

Adult deformity, scoliosis, spondylolisthesis

Brief summary

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: 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.

Interventions

OTHERNude back photo

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

Sponsors

The University of Hong Kong
Lead SponsorOTHER
Peking Union Medical College
CollaboratorOTHER
Peking University Third Hospital
CollaboratorOTHER
Beijing Chao Yang Hospital
CollaboratorOTHER
University of Malaya
CollaboratorOTHER
Nara Medical University
CollaboratorOTHER
Hamamatsu University
CollaboratorOTHER
Ruijin Hospital
CollaboratorOTHER
Huashan Hospital
CollaboratorOTHER
Zhejiang University
CollaboratorOTHER
Ji Shui Tan Hospital
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 80 Years

Inclusion criteria

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

Exclusion criteria

* Refusal for imaging, postoperative patients

Design outcomes

Primary

MeasureTime frameDescription
Cobb angle1 yearCoronal 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

Secondary

MeasureTime frameDescription
Thoracic kyphosis1 yearThoracic kyphosis T5-12: angle between upper endplate of T5 to lower endplate of T12 in the lateral radiograph
Lumbar lordosis1 yearLumbar lordosis L1-S1: angle between upper endplate of L1 to top of S1 in the lateral radiograph
Pelvic tilt1 yearPelvic tilt angle measurement in degrees in the lateral radiograph
Sacral slope1 yearSacral slope angle measurement in degrees in the lateral radiograph
Pelvic incidence1 yearPelvic incidence angle measurement in degrees in the lateral radiograph
Maximum thoracic kyphosis1 yearMaximum 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
Curve severity1 yearSeverity classifications: normal-mild; moderate and severe

Countries

Hong Kong

Contacts

CONTACTJason Pui Yin Cheung, MD, MS
cheungjp@hku.hk(852) 22554254
CONTACTTeng Zhang, PhD
tgzhang@hku.hk(852) 22554254
PRINCIPAL_INVESTIGATORJason Pui Yin Cheung, MD, MS

Queen Mary Hospital, Duchess of Kent Children's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026