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NCT Number: NCT04746417

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

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duchess of Kent Children's Hospital

Hong Kong

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. PFEO stages

    Time frame: 8 to 18 years

    Grade 1 to Grade 6

Secondary outcomes

  1. Growth parameters

    Time frame: 8 to 18 years

    Standing body height

  2. Growth parameters

    Time frame: 8 to 18 years

    Arm span

Other outcomes

  1. Curve progression

    Time frame: 8 to 18 years

    Coronal Cobb angle

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Feb 9, 2021
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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