Skeletal Age MaturationBASICNCT04216914
BASIC Study: Bone Age Study In Children
A study testing Hand outline in people with Skeletal Age Maturation, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study will see if the introduction of a hand outline on the Xray plate on which the child rests their hand will improve the quality of the Xray and reduce exposure to additional radiation by not having xrays repeated. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Skeletal Age Maturation
- What is being tested?
- Hand outline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children who are having a bone age Xray as part of their endocrinological hospital management.
Who cannot join
- Patients who do not give informed consent to be included in the study.
- As this study is very small and non externally funded, we will not be able to produce translations of the information sheets and consent/assent forms. This means that where patients are unable to fully give informed consent due to language barriers, they will be excluded from the study.
- )Any child with a left hand abnormality making them unable to place their hand flat e.g. contractures will be excluded.
- Any child too young or with significant enough learning difficulties making their compliance with the instructions too problematic. This will be at the discretion of the medical professional consenting the patient and the radiographer.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire District), S10 2TH
About this study
Official title: Bone Age Study In Children (BASIC): A Simple Intervention to Improve the Quality of Bone Age X-rays
This study will see if the introduction of a hand outline on the Xray plate on which the child rests their hand will improve the quality of the Xray and reduce exposure to additional radiation by not having xrays repeated. The child will be asked to stretch their hand flat to match the outline, thus ensuring the correct position.
Read the detailed description
The study of left wrist/hand Xrays can help children's doctors to ascertain the age of a child's skeleton, know how much growing they still have to do and predict how tall they will be as an adult. The Xray requires the child to keep their hand flat and still and in the correct orientation. Some children, especially young ones, find this difficult and therefore the quality of the Xray can mean that aging the skeleton is difficult and may require the Xray to be taken again.
This study will see if the introduction of a hand outline on the Xray plate on which the child rests their hand will improve the quality of the Xray and reduce exposure to additional radiation by not having xrays repeated. The child will be asked to stretch their hand flat to match the outline, thus ensuring the correct position.
- Conditions
- Skeletal Age Maturation
- Being tested
- Hand outline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand outlineDevice
A simple outline of a hand, to which the child tried to match their own hand on order to improve positioning.
| Study group | Role | What they receive |
|---|---|---|
| Use of hand outline for bone age xray | Experimental | Where children and young people are having left hand X-rays for clinical purposes the radiographer will place a template under their hand. The plate is designed not to show up on the X-ray and to not interfere with the X-ray itself. They will be asked to match their hand to the hand outline on the template. Receives: Device: Hand outline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in X-ray quality score with use of hand outline for TW3 x-rays
Will providing a radiolucent hand outline, to help children correctly position their hand whilst having a bone aging X-ray taken.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study startMar 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Age MaturationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte Elder, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216914
- Sponsor's protocol ID
- SCH/13/048
- Acronym
- BASIC
- Status last verified
- Dec 2019
- First submitted
- 23 Apr 2015
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Age Study In Children (BASIC): A Simple Intervention to Improve the Quality of Bone Age X-rays
- ClinicalTrials.gov ID
- NCT04216914
- Acronym / sponsor ID
- BASIC / SCH/13/048
- Conditions
- Skeletal Age Maturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will see if the introduction of a hand outline on the Xray plate on which the child rests their hand will improve the quality of the Xray and reduce exposure to additional radiation by not having xrays repeated. The child will be asked to stretch their hand flat to match the outline, thus ensuring the correct position.
Detailed description
The study of left wrist/hand Xrays can help children's doctors to ascertain the age of a child's skeleton, know how much growing they still have to do and predict how tall they will be as an adult. The Xray requires the child to keep their hand flat and still and in the correct orientation. Some children, especially young ones, find this difficult and therefore the quality of the Xray can mean that aging the skeleton is difficult and may require the Xray to be taken again.
This study will see if the introduction of a hand outline on the Xray plate on which the child rests their hand will improve the quality of the Xray and reduce exposure to additional radiation by not having xrays repeated. The child will be asked to stretch their hand flat to match the outline, thus ensuring the correct position.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of hand outline for bone age xray | Experimental | Device: Hand outlineWhere children and young people are having left hand X-rays for clinical purposes the radiographer will place a template under their hand. The plate is designed not to show up on the X-ray and to not interfere with the X-ray itself. They will be asked to match their hand to the hand outline on the template. |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children who are having a bone age Xray as part of their endocrinological hospital management.
Key exclusion criteria (4 listed)
- Patients who do not give informed consent to be included in the study.
- As this study is very small and non externally funded, we will not be able to produce translations of the information sheets and consent/assent forms. This means that where patients are unable to fully give informed consent due to language barriers, they will be excluded from the study.
- )Any child with a left hand abnormality making them unable to place their hand flat e.g. contractures will be excluded.
- Any child too young or with significant enough learning difficulties making their compliance with the instructions too problematic. This will be at the discretion of the medical professional consenting the patient and the radiographer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand outlineA simple outline of a hand, to which the child tried to match their own hand on order to improve positioning. | Device | Use of hand outline for bone age xray |
Primary outcome
Change in X-ray quality score with use of hand outline for TW3 x-rays
Time frame: 16 months
Will providing a radiolucent hand outline, to help children correctly position their hand whilst having a bone aging X-ray taken.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Elder principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand outline in people with Skeletal Age Maturation, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in X-ray quality score with use of hand outline for TW3 x-rays (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.