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Optimal Index for Pediatric Distal Forearm Fractures

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05425758
Collaborator
(none)
60
Enrollment
5
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    What is the Optimal Index for Assessment of Plaster Cast Quality in Pediatric Distal Forearm Fractures
    Anticipated Study Start Date :
    Jul 1, 2022
    Anticipated Primary Completion Date :
    Sep 30, 2022
    Anticipated Study Completion Date :
    Nov 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. The cast index [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.

    2. The gap index [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.

    3. The padding index [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. The Canterbury index [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.

    5. The three-point index [4 weeks observation after reduction and applying cast.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Meena Mikhael Rizk, Principal Investigator of orthopedic surgery, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05425758
    Other Study ID Numbers:
    • Soh-Med-22-05-07
    First Posted:
    Jun 21, 2022
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Meena Mikhael Rizk, Principal Investigator of orthopedic surgery, Sohag University
    Optimal index for Pediatric distal forearm fractures
    Additional relevant MeSH terms:
    Fractures, Bone

    Study Results

    No Results Posted as of Jun 21, 2022