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Validation of the Utility of an Artificial System for the Large-scale Screening of Scoliosis

Sun Yat-sen University logo

Sun Yat-sen University

Status

Completed

Conditions

Artificial Intelligence
Orthopedic Disorder of Spine
Scoliosis

Treatments

Device: An artificial system for the screening of scoliosis

Study type

Interventional

Funder types

Other

Identifiers

NCT03773458
CCPMOH2018-China-13

Details and patient eligibility

About

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.

Enrollment

500 patients

Sex

Ages

10 to 22 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 1.Patients included both pretreatment back photos and whole spine (C7-S1) standing X-ray or ultrasound images (for healthy population); 2. All the documents are clear to be recognized by naked eyes; 3. Back photos and are taken at the same time (not >1month); 4.Patients were consider as idiopathic scoliosis according to clinical photos.

Exclusion criteria

    1. 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; 4. The X-ray film or ultrasound images not including whole spine (C7-S1).

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

500 participants in 1 patient group

Eligible patients for AI test.
Other group
Description:
Device: An artificial system for the screening of scoliosis
Treatment:
Device: An artificial system for the screening of scoliosis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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