Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT05146193
Status:
RECRUITING
Last Update Posted:
2025-03-25
First Post:
2021-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI-Powered Scoliosis Auto-Analysis System Multicenter Development and Validations
Sponsor:
The University of Hong Kong
Organization:
Study Overview
Official Title:
AI-Powered Scoliosis Auto-Analysis System Multicenter Development and Validations
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: