Exposed Versus Buried Intramedullary K-wires for Pediatric Forearm Fractures

August 8, 2022 updated by: Andrew Nabil Fouad Gergis, Assiut University

Exposed Versus Buried Intramedullary K-wires for Pediatric Forearm Fractures: a Randomized Controlled Trial.

Comparing the rate of complications between buried and exposed intramedullary implants after fixation of pediatric forearm fractures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

comparison between buried and exposed intramedullary k-wire in fixation of pediatric forearm fracture in rate of complications such as infection,malunion,nonunion and refracture.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assuit, Egypt
        • Assuit u. hospital

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

5 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: less than 10 years .
  2. Diaphyseal forearm fracture.
  3. closed fracture.
  4. isolated or combined fracture of forearm.

Exclusion Criteria:

1. Patient age: more than 10 years old . 2-open fracture. 3- pathological fracture. 4-patient with medical history (immune compromized patient e.g D.M, cancer on chemotherapy and aplastic anemia).

5- neurovascular injury.

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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pediatric forearm fracture fixed by buried or exposed intamedullary implant
compare complication of buried or exposed intamedullary implant
Device: buried intramedullary K-wire
Using of buried kirschner wire in pediatric forearm fixation
Other Names:
  • buried intramedullary kirschner wire
Device: exposed intramedullary K-wire
Using of exposed kirschner wire in pediatric forearm fixation
Other Names:
  • exposed intramedullary kirschner wire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare the rate of refracture in participants who fixed by buried and exposed K-wire.
Time Frame: 6 months
comparison between the rate of refractures in participants who fixed by buried and exposed K-wire by follow up every month for six month.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare the rate of infection and malunion in participants who fixed by buried and exposed K-wire.
Time Frame: 6 months
compare the rate of infection and malunion in participants who fixed by buried and exposed K-wire.
6 months

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mohamed K Hassan, professor, professor of orthopedic and traumatology Assuit university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

September 1, 2019

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 5, 2019

First Posted (Actual)

April 8, 2019

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fixation of forearm fracture

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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