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NCT04746417 Clinical Trial

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

Idiopathic Scoliosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04746417
Other study ID # FVersion 1.0
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date February 1, 2025

Study information
Verified date May 2023
Source The University of Hong Kong
Contact J Cheung
Phone 22554654
Email cheungjp@hku.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date February 1, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Hong Kong Duchess of Kent Children's Hospital Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome
Type Measure Description Time frame Safety issue
Other Curve progression Coronal Cobb angle 8 to 18 years
Primary PFEO stages Grade 1 to Grade 6 8 to 18 years
Secondary Growth parameters Standing body height 8 to 18 years
Secondary Growth parameters Arm span 8 to 18 years
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