Optimal Index for Pediatric Distal Forearm Fractures

Pediatric Distal Forearm Fractures Clinical Trial

Official title:

What is the Optimal Index for Assessment of Plaster Cast Quality in Pediatric Distal Forearm Fractures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05425758
• Other study ID #: Soh-Med-22-05-07
• Status: Not yet recruiting
• Start date: July 1, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: June 2022
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 evaluated.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Pediatric Distal Forearm Fractures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cast index	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.
Primary	The gap index	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.
Primary	The padding index	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.
Primary	The Canterbury index	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.
Primary	The three-point index		4 weeks observation after reduction and applying cast.