NCT06589583

Brief Summary

The aim of the study to use artificial intelligence technology in assessment of scoliosis degree of severity and to personalize for treatment plan for each pa tient .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

September 2, 2024

Last Update Submit

September 18, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • test the validity and reliability of software

    ability of the models to differentiate normal from scoliotic x-ray (automatic classification) which helps in diagnosis of scoliosis by identifying the curve .

    2 months

  • determine degree of curve severity via measurement cobb's angle by degree

    for grading of scoliosis severity (mild or moderate or sever )

    2 months

  • suggested treatment program according to each patient need .in form points

    in case of mild scoliosis the intervention will be conservative on other hand in moderate curve intervention will be conservatives and orthotic management while in sever suggested surgical interface.

    2 moths

Eligibility Criteria

Age15 Years - 37 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All spinal X-ray involved in this study were retrospectively compiled from manifold sources, including BUU \&amp Datasets, Kaggle, Mendeley Data, Huggingface, Dropbox , and Roboflow, ensuring a diverse and comprehensive collection of scoliosis-related images .

You may qualify if:

  • ). Patient with scoliosis were
  • diagnosed with scoliosis for different etiology.
  • Clear X- Ray for spine for all spinal curvatures including; cervical, thoracic and lumber(PA)view.
  • C shaped and double C shape scoliosis such as (Thoracolumbar-cervicothoracic scoliosis).
  • Mild, moderate and severe scoliotic degrees.
  • Adolescents with mean age 17 years old
  • Male and female gender

You may not qualify if:

  • children with scoliosis
  • age less than 12 years old .
  • lateral view spine x- ray.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delta university

Gamasa, Dakahlia Governorate, 35511, Egypt

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator of pediatrics and its surgery

Study Record Dates

First Submitted

September 2, 2024

First Posted

September 19, 2024

Study Start

July 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

September 20, 2024

Record last verified: 2024-09

Locations