- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04746417
Assessment of Skeletal Maturity Using Proximal Femoral Epiphysis in Patients With Scoliosis
April 27, 2026 updated by: Dr. Jason Pui Yin Cheung, The University of Hong Kong
Validation of the Assessment of Skeletal Maturity Using Femoral Head in Patients With Idiopathic Scoliosis and Its Clinical Implications
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hong Kong, Hong Kong
- Duchess of Kent Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients presented to our tertiary scoliosis clinic with referral for specialist consultation of scoliosis - we particularly focus on scoliosis of idiopathic nature
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PFEO stages
Time Frame: 8 to 18 years
|
Grade 1 to Grade 6
|
8 to 18 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Growth parameters
Time Frame: 8 to 18 years
|
Standing body height
|
8 to 18 years
|
|
Growth parameters
Time Frame: 8 to 18 years
|
Arm span
|
8 to 18 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Curve progression
Time Frame: 8 to 18 years
|
Coronal Cobb angle
|
8 to 18 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2021
Primary Completion (Actual)
December 31, 2025
Study Completion (Actual)
February 1, 2026
Study Registration Dates
First Submitted
February 2, 2021
First Submitted That Met QC Criteria
February 5, 2021
First Posted (Actual)
February 9, 2021
Study Record Updates
Last Update Posted (Actual)
April 29, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FVersion 1.0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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