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OpenTrials
Completed

NCT Number: NCT03773458

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

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.

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Key information

Conditions

Orthopedic Disorder of Spine Artificial Intelligence Bone Diseases Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

10 year–22 year

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

An artificial system for the screening of scoliosis

Device

An artificial intelligence to make evaluation of scoliosis using back images

Primary outcomes

  1. The proportion of accurate, mistaken and miss detection of the intelligent visual acuity diagnostic system.

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 12, 2018
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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