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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Deformity
• Intervention / Treatment: Other: Nude back photo

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.

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Jason Pui Yin Cheung, MD, MS; Phone Number: (852) 22554254; Email: cheungjp@hku.hk
• Study Contact Backup: Name: Teng Zhang, PhD; Phone Number: (852) 22554254; Email: tgzhang@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Duchess of Kent Children's Hospital
    • Contact: Jason Cheung; Phone Number: 85222554581 85222554581; Email: cheungjp@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All subjects with spinal deformities

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Refusal for imaging, postoperative patients

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All subjects are diagnosed of having a spinal deformity; Routine care of patients with spinal deformities	Other: Nude back photo; Nude back photo at baseline and at follow-ups for each patient and visual severity and curve type classifications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thoracic kyphosis	Thoracic kyphosis T5-12: angle between upper endplate of T5 to lower endplate of T12 in the lateral radiograph	1 year
Lumbar lordosis	Lumbar lordosis L1-S1: angle between upper endplate of L1 to top of S1 in the lateral radiograph	1 year
Pelvic tilt	Pelvic tilt angle measurement in degrees in the lateral radiograph	1 year
Sacral slope	Sacral slope angle measurement in degrees in the lateral radiograph	1 year
Pelvic incidence	Pelvic incidence angle measurement in degrees in the lateral radiograph	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	1 year
Curve severity	Severity classifications: normal-mild; moderate and severe	1 year

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: University of Malaya; Peking University Third Hospital; Huashan Hospital; Hamamatsu University; Ruijin Hospital; Beijing Chao Yang Hospital; Zhejiang University; Peking Union Medical College; Nara Medical University; Ji Shui Tan Hospital
• Investigators: Principal Investigator: Jason Pui Yin Cheung, MD, MS, Queen Mary Hospital, Duchess of Kent Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Adult deformity, scoliosis, spondylolisthesis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Congenital Abnormalities; Scoliosis
• Other Study ID Numbers: AI_Scoliosis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No