Developing a COMputerised Bone Age Tool

NCT ID: NCT02617901

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-04-30

Brief Summary

The Greulich and Pyle technique (G&P) is that most commonly used to assess bone age in children, particularly in the context of suspected skeletal dysplasia. However it has been shown not to be applicable to children of Asian and African ethnicity and may not be applicable to United Kingdom (UK) Caucasian children, who are now relatively more mature and larger than children of the mid 1930's (when G&P was developed). It is generally agreed that updated standards are required for rapid and reliable bone age assessment. The development of such standards requires irradiation of normal children. To do this ethically, radiation exposure must be kept as low as possible. Two recent studies suggest that bone age assessment can be reliably achieved from dual-energy x-ray absorptiometry (DXA) scans. As far as the investigators are aware, the Tanner & Whitehouse (TW3) method, which is preferred by some (e.g. endocrinologists and nutritionists), has not been assessed from dual-energy x-ray absorptiometry (DXA) scans - although not the main focus of this study, because of its popularity amongst certain specialties, the investigators shall be assessing the TW3 method also. Modern techniques should not only be available as textbooks, but should also be available in digital (on-line) format and where possible integrated with hospital PACS systems. The investigators believe that their team has the required experience and expertise to successfully carry out such a project. Before conducting the required large cross-sectional study, the investigators must first confirm that DXA can in fact replace radiographs for bone age assessment in children; which is the objective of this current study.

Detailed Description

This is a small prospective feasibility study to be performed over a 12-month period.

Children booked for a left hand radiograph for bone age assessment (either in isolation or as part of a dysplasia skeletal survey) will be recruited. This will require a purposive sample of 2 males and 2 females from each of the following 5 age groups (<5; 5 to 7; 8 to 10; 11 to 13; 14 to 16 years). There will therefore be a total of 20 children (10 males). Because the aim of the study is to compare results of DXA with those of radiographs in corresponding children, ethnicity of individual children will not be an issue; in other words the investigators are assessing the reliability of DXA not the reliability of G&P or TW3.

Relevant clinicians will identify patients from appropriate clinics at Sheffield Children's Hospital. Only patients having a left hand radiograph for bone age assessment on the basis of clinical need will be approached. Age appropriate information sheets will be given to them, and the study briefly discussed. When they arrive at the Radiology Department for their left hand radiograph, an appropriately certified radiographer will seek informed consent and provided the left hand radiograph is actually performed, they will then also have DXA of the left hand and those over 6 years old will be asked to complete a brief questionnaire.

Researcher 1 will anonymise hand radiographs and DXA scans, such that corresponding patient images are not identifiable. Researcher 1 will also document patient age and sex, ethnicity and body weight and height (no other clinical information is required for the purposes of this feasibility study).

Researchers 2, 3 and 4 will independently assess all images using both G&P and TW3. All observers will interpret a random selection of half the images (again independently) on a second occasion at least 2 months after the first; on both occasions the Images will be interpreted in random and varied order. Images will be read in two batches of 10 radiographs and 10 (non-corresponding) DXA scans for the first read and 5 radiographs and 5 (non-corresponding) DXA scans for the second read.

Statistical analysis is largely irrelevant for this small feasibility study. The investigators' main aim is to assess whether or not G&P and TW3 can be reliably assessed from hand DXA images.

The concordance between 1) independent readings of the three observers for radiographs and for DXA (i.e. comparing modalities) and 2) individual observers for both occasions (i.e. comparing observer reliability for each modality) will be evaluated using interclass and intraclass correlation coefficients. The investigators will calculate the mean and standard deviation of the differences between DXA and radiographs and between observers.

Statistical analyses will be performed using the Statistical Package for the Social Sciences, version 21 for Mac (SPSS, Chicago, IL).

Conditions

Bone Diseases, Developmental

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Recruited children

Children aged below 16 years attending the Radiology Department for a left hand radiograph in order to assess bone age on the basis of clinical need. There will be one male and one female from each of five age groups (< 5 years; 5 to 7 years; 8 to 10 years; 11 to 13 years; 14 to 16 years).

Bone age will be assessed according to the Greulich & Pyle and TW3 methods by 3 observers on 2 separate occasions at least 4 weeks apart. Recruited children will have intervention in the form of a left hand DXA which will be anonymised and from which the same 3 observers will independently assess bone age according to Greulich and Pyle and TW3 methods on 2 separate occasions at least 4 weeks apart.

Radiographs and DXA will be read in random and varied order.

Group Type: EXPERIMENTAL

Left hand DXA

Intervention Type: RADIATION

All recruited children will have a left hand DXA scan which will be anonymised and from which 3 observers will independently assess bone age according to Greulich and Pyle and TW3 methods on 2 separate occasions at least 4 weeks apart.

Radiographs and DXA will be read in random and varied order.

Interventions

Left hand DXA

All recruited children will have a left hand DXA scan which will be anonymised and from which 3 observers will independently assess bone age according to Greulich and Pyle and TW3 methods on 2 separate occasions at least 4 weeks apart.

Radiographs and DXA will be read in random and varied order.

Intervention Type: RADIATION

Other Intervention Names

DXA of left hand and wrist

Eligibility Criteria

Inclusion Criteria

1. Children having a left hand radiograph performed to assess bone age on the basis of clinical need

2. Children and families who have given fully informed consent/assent

3. Children and families capable of reading and/or writing English

Exclusion Criteria

1. Participants who might not adequately understand verbal explanations or written information given in English, or who have special communication needs

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sheffield

OTHER

Sponsor Role: collaborator

Sheffield Children's NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amaka Offiah

Role: PRINCIPAL_INVESTIGATOR

Investigator

Locations

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire District), United Kingdom

Countries

United Kingdom

References

Mora S, Boechat MI, Pietka E, Huang HK, Gilsanz V. Skeletal age determinations in children of European and African descent: applicability of the Greulich and Pyle standards. Pediatr Res. 2001 Nov;50(5):624-8. doi: 10.1203/00006450-200111000-00015.

Reference Type: BACKGROUND

PMID: 11641458 (View on PubMed)

van Rijn RR, Lequin MH, Robben SG, Hop WC, van Kuijk C. Is the Greulich and Pyle atlas still valid for Dutch Caucasian children today? Pediatr Radiol. 2001 Oct;31(10):748-52. doi: 10.1007/s002470100531.

Reference Type: BACKGROUND

PMID: 11685448 (View on PubMed)

Soudack M, Ben-Shlush A, Jacobson J, Raviv-Zilka L, Eshed I, Hamiel O. Bone age in the 21st century: is Greulich and Pyle's atlas accurate for Israeli children? Pediatr Radiol. 2012 Mar;42(3):343-8. doi: 10.1007/s00247-011-2302-1. Epub 2012 Jan 12.

Reference Type: BACKGROUND

PMID: 22237478 (View on PubMed)

Other Identifiers

SCH/14/010

Identifier Type: -

Identifier Source: org_study_id