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

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

Detailed Description
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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.

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

Conditions
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Spinal Deformity

Intervention / Treatment
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* Other: Nude back photo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic scoliosis, adult deformity (spondylolisthesis, idiopathic kyphosis, kyphoscoliosis, lordoscoliosis) Exclusion Criteria: Refusal for imaging, postoperative patients

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult deformity, scoliosis, spondylolisthesis