Assessment of Skeletal Maturity Using Proximal Femoral Epiphysis in Patients With Scoliosis

Recruiting

• Conditions: Idiopathic Scoliosis

• Registration Number: NCT04746417
• Lead Sponsor: The University of Hong Kong

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PFEO stages	8 to 18 years	Grade 1 to Grade 6

Secondary Outcome Measures

Name	Time	Method
Growth parameters	8 to 18 years	Arm span

Trial Locations

Locations (1)

Duchess of Kent Children's Hospital; 🇭🇰 Hong Kong, Hong Kong