Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Developing a COMputerised Bone Age Tool (COMBAT1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02617901
Recruitment Status : Completed
First Posted : December 1, 2015
Results First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
University of Sheffield
Information provided by (Responsible Party):
Sheffield Children's NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Bone Diseases, Developmental Radiation: Left hand DXA Not Applicable

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: COMBAT 1: COMputerised Bone Age Tool (Phase 1: Feasibility of Using Dual Energy X-ray Absorptiometry for Bone Age Assessment in Children)
Study Start Date : December 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

Radiation: 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.

Other Name: DXA of left hand and wrist




Primary Outcome Measures :
  1. Bone Age as Assessed by DXA [ Time Frame: 18 months ]
    Interclass correlation (for observer agreement between radiographs and DXA)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Eligibility:

  1. Both female and male participants are being studied
  2. Minimum age 1 year
  3. Maximum age 15 years and 364 days
  4. Healthy volunteers will not be recruited

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617901


Locations
Layout table for location information
United Kingdom
Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire district), United Kingdom, S10 2TH
Sponsors and Collaborators
Sheffield Children's NHS Foundation Trust
University of Sheffield
Investigators
Layout table for investigator information
Principal Investigator: Amaka Offiah Investigator

Publications:
Layout table for additonal information
Responsible Party: Sheffield Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02617901     History of Changes
Other Study ID Numbers: SCH/14/010
First Posted: December 1, 2015    Key Record Dates
Results First Posted: October 13, 2017
Last Update Posted: October 13, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results will be submitted for publication in a peer-reviewed journal. Raw data available on request.

Keywords provided by Sheffield Children's NHS Foundation Trust:
Bone age
Greulich & Pyle
TW3
Radiography
Dual energy x-ray absorptiometry

Additional relevant MeSH terms:
Layout table for MeSH terms
Bone Diseases
Bone Diseases, Developmental
Musculoskeletal Diseases