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NCT Number: NCT05146193

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

The investigators aim to use artificial intelligence (AI) to help clinicians in diagnosing and assessing spinal deformities.

Recruiting

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Key information

Age range

10 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duchess of Kent Children's Hospital

Hong Kong

Location status: Recruiting

Location contact

Jason Cheung

CONTACT

[email protected]

85222554581 ext. 85222554581

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Refusal for imaging, postoperative patients

Treatment and study plan

Nude back photo

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Thoracic kyphosis

    Time frame: 1 year

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

  2. Lumbar lordosis

    Time frame: 1 year

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

  3. Pelvic tilt

    Time frame: 1 year

    Pelvic tilt angle measurement in degrees in the lateral radiograph

  4. Sacral slope

    Time frame: 1 year

    Sacral slope angle measurement in degrees in the lateral radiograph

  5. Pelvic incidence

    Time frame: 1 year

    Pelvic incidence angle measurement in degrees in the lateral radiograph

  6. Maximum thoracic kyphosis

    Time frame: 1 year

    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

  7. Curve severity

    Time frame: 1 year

    Severity classifications: normal-mild; moderate and severe

Study contacts

Contact information is provided by the study sponsor or research team.

Jason Pui Yin Cheung, MD, MS

CONTACT

[email protected]

(852) 22554254

Teng Zhang, PhD

CONTACT

[email protected]

(852) 22554254

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Beijing Chao Yang Hospital
  • Hamamatsu University
  • Huashan Hospital
  • Ji Shui Tan Hospital
  • Nara Medical University
  • Peking Union Medical College
  • Peking University Third Hospital
  • Ruijin Hospital
  • University of Malaya
  • Zhejiang University

Registry information

Important dates

Study start
2022
Primary completion
2029
Study completion
2030
First posted
Dec 6, 2021
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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