NCT05146193

Brief Summary

The investigators aim to use artificial intelligence (AI) to help clinicians in diagnosing and assessing spinal deformities.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress52%
May 2022Feb 2030

First Submitted

Initial submission to the registry

November 12, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2030

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

6.8 years

First QC Date

November 12, 2021

Last Update Submit

April 27, 2026

Conditions

Spinal Deformity

Keywords

Adult deformity, scoliosis, spondylolisthesis

Outcome Measures

Primary Outcomes (1)

  • Cobb angle

    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

    1 year

Secondary Outcomes (7)

  • Thoracic kyphosis

    1 year

  • Lumbar lordosis

    1 year

  • Pelvic tilt

    1 year

  • Sacral slope

    1 year

  • Pelvic incidence

    1 year

  • +2 more secondary outcomes

Study Arms (1)

All subjects are diagnosed of having a spinal deformity

Routine care of patients with spinal deformities

Other: Nude back photo

Interventions

Nude back photoOTHER

Nude back photo at baseline and at follow-ups for each patient and visual severity and curve type classifications

All subjects are diagnosed of having a spinal deformity

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All subjects with spinal deformities

You may qualify if:

  • Idiopathic scoliosis, adult deformity (spondylolisthesis, idiopathic kyphosis, kyphoscoliosis, lordoscoliosis)

You may not qualify if:

  • Refusal for imaging, postoperative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duchess of Kent Children's Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Congenital AbnormalitiesScoliosisSpondylolisthesis

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesSpinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesSpondylolysisSpondylosis

Study Officials

  • Jason Pui Yin Cheung, MD, MS

    Queen Mary Hospital, Duchess of Kent Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Pui Yin Cheung, MD, MS

CONTACT

(852) 22554254cheungjp@hku.hk

Teng Zhang, PhD

CONTACT

(852) 22554254tgzhang@hku.hk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

November 12, 2021

First Posted

December 6, 2021

Study Start

May 1, 2022

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2030

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)