Pediatric Distal Forearm FracturesNCT05425758
Optimal Index for Pediatric Distal Forearm Fractures
An observational study of Pediatric Distal Forearm Fractures, run by Sohag University.
Trial summary
This is a prospective radiographic study of displaced distal forearm fractures requiring manipulation for children 3-12 years of age and will be treated with casting.The patients' full radiographic series (including the pre-manipulation, immediate post-manipulation, after 1 week and after 4 weeks radiographs) will be… Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Pediatric Distal Forearm Fractures
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 30 Nov 2022
- Phase
- Observational
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children 3-12 years of age with displaced distal forearm fractures requiring manipulation for and will be treated with casting.
Who may be able to join
- Males or females 3 to 12 years old.
- Any presentation of displaced distal forearm fractures requiring manipulation and will be treated with casting.
Who cannot join
- Children with compound fractures (those with unacceptable initial reduction, fracture dislocations, and fractures with physeal separation) will be excluded from the study, as those will be treated with Kirschner wires.
- Children whose casts is split will be excluded.
About this study
Official title: What is the Optimal Index for Assessment of Plaster Cast Quality in Pediatric Distal Forearm Fractures
This is a prospective radiographic study of displaced distal forearm fractures requiring manipulation for children 3-12 years of age and will be treated with casting.The patients' full radiographic series (including the pre-manipulation, immediate post-manipulation, after 1 week and after 4 weeks radiographs) will be evaluated.
- Conditions
- Pediatric Distal Forearm Fractures
- Keywords
- Optimal index for Pediatric distal forearm fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
The cast index
formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement.
Measured: 4 weeks observation after reduction and applying cast.
The gap index
formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement.
Measured: 4 weeks observation after reduction and applying cast.
The padding index
formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement.
Measured: 4 weeks observation after reduction and applying cast.
The Canterbury index
formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement.
Measured: 4 weeks observation after reduction and applying cast.
The three-point index
Measured: 4 weeks observation after reduction and applying cast.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Distal Forearm FracturesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meena Mikhael Rizk, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425758
- Sponsor's protocol ID
- Soh-Med-22-05-07
- Status last verified
- Jun 2022
- First submitted
- 11 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Optimal Index for Assessment of Plaster Cast Quality in Pediatric Distal Forearm Fractures
- ClinicalTrials.gov ID
- NCT05425758
- Acronym / sponsor ID
- Soh-Med-22-05-07
- Conditions
- Pediatric Distal Forearm Fractures
- Keywords
- Optimal index for Pediatric distal forearm fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 21 Jun 2022 (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 is a prospective radiographic study of displaced distal forearm fractures requiring manipulation for children 3-12 years of age and will be treated with casting.The patients' full radiographic series (including the pre-manipulation, immediate post-manipulation, after 1 week and after 4 weeks radiographs) will be evaluated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children 3-12 years of age with displaced distal forearm fractures requiring manipulation for and will be treated with casting.
Key inclusion criteria (2 listed)
- Males or females 3 to 12 years old.
- Any presentation of displaced distal forearm fractures requiring manipulation and will be treated with casting.
Key exclusion criteria (2 listed)
- Children with compound fractures (those with unacceptable initial reduction, fracture dislocations, and fractures with physeal separation) will be excluded from the study, as those will be treated with Kirschner wires.
- Children whose casts is split will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The cast index
Time frame: 4 weeks observation after reduction and applying cast.
formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement.
The gap index
Time frame: 4 weeks observation after reduction and applying cast.
formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement.
The padding index
Time frame: 4 weeks observation after reduction and applying cast.
formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement.
The Canterbury index
Time frame: 4 weeks observation after reduction and applying cast.
formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement.
The three-point index
Time frame: 4 weeks observation after reduction and applying cast.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Distal Forearm Fractures, run by Sohag University.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
The cast index (time frame: 4 weeks observation after reduction and applying cast.). The study lists 5 primary outcomes in all. 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 21 Jun 2022.