Optimal Index for Pediatric Distal Forearm Fractures

June 15, 2022 updated by: Meena Mikhael Rizk, Sohag University

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

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

3 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children 3-12 years of age with displaced distal forearm fractures requiring manipulation for and will be treated with casting.

Description

Inclusion Criteria:

  1. Males or females 3 to 12 years old.
  2. Any presentation of displaced distal forearm fractures requiring manipulation and will be treated with casting.

Exclusion Criteria:

  1. 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.
  2. Children whose casts is split will be excluded.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks observation after reduction and applying cast.
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.
4 weeks observation after reduction and applying cast.
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.
4 weeks observation after reduction and applying cast.
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.
4 weeks observation after reduction and applying cast.
The three-point index
Time Frame: 4 weeks observation after reduction and applying cast.
4 weeks observation after reduction and applying cast.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

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 (ANTICIPATED)

July 1, 2022

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

November 30, 2022

Study Registration Dates

First Submitted

June 11, 2022

First Submitted That Met QC Criteria

June 15, 2022

First Posted (ACTUAL)

June 21, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 21, 2022

Last Update Submitted That Met QC Criteria

June 15, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-22-05-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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