AI-Powered Scoliosis Auto-Analysis System Multicenter Development and Validations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Cobb angle
研究概览
简要总结
The investigators aim to use artificial intelligence (AI) to help clinicians in diagnosing and assessing spinal deformities.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic scoliosis, adult deformity (spondylolisthesis, idiopathic kyphosis, kyphoscoliosis, lordoscoliosis)
排除标准
- •Refusal for imaging, postoperative patients
研究组 & 干预措施
All subjects are diagnosed of having a spinal deformity
Routine care of patients with spinal deformities
干预措施: Nude back photo (Other)
结局指标
主要结局
Cobb angle
时间窗: 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
次要结局
- Curve severity(1 year)
- Lumbar lordosis(1 year)
- Sacral slope(1 year)
- Pelvic incidence(1 year)
- Thoracic kyphosis(1 year)
- Pelvic tilt(1 year)
- Maximum thoracic kyphosis(1 year)
研究者
Dr. Jason Pui Yin Cheung
Clinical Associate Professor
The University of Hong Kong