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

Spinal Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05146193
• Other study ID #: AI_Scoliosis
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: February 1, 2025

Study information

• Verified date: November 2023
• Source: The University of Hong Kong
• Contact: Jason Pui Yin Cheung, MD, MS
• Phone: (852) 22554254
• Email: cheungjp[@]hku.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Gender: All
• Age group: 10 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Refusal for imaging, postoperative patients

Related Conditions & MeSH terms

• Congenital Abnormalities
• Scoliosis
• Spinal Deformity

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Duchess of Kent Children's Hospital	Hong Kong

Sponsors (11)

Lead Sponsor	Collaborator
The University of Hong Kong	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

Country where clinical trial is conducted

Hong Kong, 

Outcome

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