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Clinical Trials/NCT04746417
NCT04746417
Completed
Not Applicable

Validation of the Assessment of Skeletal Maturity Using Femoral Head in Patients With Idiopathic Scoliosis and Its Clinical Implications

The University of Hong Kong2 sites in 1 country70 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Idiopathic Scoliosis
Sponsor
The University of Hong Kong
Enrollment
70
Locations
2
Primary Endpoint
PFEO stages
Status
Completed
Last Updated
3 days ago

Overview

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.

Detailed Description

There are multiple skeletal maturity measures currently in use which were established with reliability in assessing growth. The advantages and shortcomings of each index was previously examined. This study aims to explore the use of proximal femoral epiphysis, which is in close proximity of the radiographic field of the spine, in assessing the growth status of patients with idiopathic scoliosis. The stages of the proximal femoral epiphyseal ossification has been established with specific definitions. The reliability and reproducibility of using these gradings will be examined by orthopaedic surgeons. Subsequently, the assessment of different pubertal growth landmarks using these gradings will be validated, and to see whether these gradings can provide indications of peak growth and growth cessation. Finally, the relationships of such growth assessment using this proximal femoral epiphysis ossification (PFEO) system and the curve progression in idiopathic scoliosis will be studied.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
February 1, 2026
Last Updated
3 days ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Jason Pui Yin Cheung

Clinical Associate Professor

The University of Hong Kong

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

PFEO stages

Time Frame: 8 to 18 years

Grade 1 to Grade 6

Secondary Outcomes

  • Growth parameters(8 to 18 years)

Study Sites (2)

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