NCT04746417

Brief Summary

This study aims to explore the use of proximal femoral head for the assessment of skeletal maturity in patients with idiopathic scoliosis. The aim is to validate the use of the stages of proximal femoral epiphyseal closure in assessing pubertal growth landmarks in this patient cohort. The grading system of this skeletal maturity index will be established and its reliability and reproducibility in clinical use will be examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 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

February 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

4.9 years

First QC Date

February 2, 2021

Last Update Submit

April 27, 2026

Conditions

Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

  • PFEO stages

    Grade 1 to Grade 6

    8 to 18 years

Secondary Outcomes (2)

  • Growth parameters

    8 to 18 years

  • Growth parameters

    8 to 18 years

Other Outcomes (1)

  • Curve progression

    8 to 18 years

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients presented to our tertiary scoliosis clinic with referral for specialist consultation of scoliosis - we particularly focus on scoliosis of idiopathic nature

You may qualify if:

  • Idiopathic scoliosis
  • Open triradiate cartilage or open distal radius epiphysis without capping

You may not qualify if:

  • Non-idiopathic scoliosis
  • Patients with growth hormone deficiency or developmental delay
  • Patient has not reached skeletal maturity
  • Defaulted and lost to follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duchess of Kent Children's Hospital

Hong Kong, Hong Kong

Location

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

February 2, 2021

First Posted

February 9, 2021

Study Start

February 1, 2021

Primary Completion

December 31, 2025

Study Completion

February 1, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

HK(1)