Validation of the Utility of an Artificial System for the Large-scale Screening of Scoliosis Using Back Images
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- The proportion of accurate, mistaken and miss detection of the intelligent visual acuity diagnostic system.
Study Overview
Brief Summary
Traditional school scoliosis screening approaches remains debatable due to unnecessary referal and excessive cost. Deep learning algorithms have proven to be powerful tools for the detection of multiple diseases; however, the application of such methods in scoliosis screening requires further assessment and validation. Here, the investigators develop an artificial system for the automated screening of scoliosis using disrobed back images, and conduct clinical trial to validate if the diagnostic system can offsetting the shortcomings of human doctors.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 22 Years (Child, Adult)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •1.Patients included both pretreatment back photos and whole spine (C7-S1) standing X-ray or ultrasound images (for healthy population);
- •All the documents are clear to be recognized by naked eyes;
- •Back photos and are taken at the same time (not >1month); 4.Patients were consider as idiopathic scoliosis according to clinical photos.
Exclusion Criteria
- •Patients were considered as non-idiopathic scoliosis for obvious abnormal features of trunck,such as Cafe-au-Lait spots for neurofibromatosis, Spider finger, Abnormal hair spot of back, pelvic tilt, lower limb discrepancy and so on; 2.The taken time between back photo and X-ray or ultrasound was more than 1month; 3.The clinical photos and images were not clear;
- •The X-ray film or ultrasound images not including whole spine (C7-S1).
Arms & Interventions
Eligible patients for AI test.
Device: An artificial system for the screening of scoliosis
Intervention: An artificial system for the screening of scoliosis (Device)
Outcomes
Primary Outcomes
The proportion of accurate, mistaken and miss detection of the intelligent visual acuity diagnostic system.
Time Frame: Up to 5 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Haotian Lin
Clinical Professor
Sun Yat-sen University