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

NCT ID: NCT04746417

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2026-02-01

Brief Summary

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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

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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.

Conditions

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Idiopathic Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Jason Pui Yin Cheung

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Duchess of Kent Children's Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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J Cheung

Role: CONTACT

Facility Contacts

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Jason Cheung

Role: primary

85222554581 ext. 85222554581

Other Identifiers

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FVersion 1.0

Identifier Type: -

Identifier Source: org_study_id