Ulnar Shaft Fracture Fixation by Antegrade Versus Retrograde Intramedullary k Wires in Children

January 13, 2025 updated by: Mahmoud Ahmed Ali, Sohag University

Ulnar Shaft Fracture Fixation by Antegrade Versus Retrograde Intramedullary k Wires in Children;A Comparative Study

This study is made to see and evaluate the outcomes of treating and fixing ulnar shaft fracture in children by antegrade versus retrograde intramedullary k wires

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is made on children with ulnar shaft fracture and treating their fracture by intramedullary k wires ,dividing them into two groups ,one of them the child ulnar fracture is reduced and fixed by intramedullary antegrade k wire and the other group the fracture is reduced and fixed by retrograde k wire ,and compare the functional, clinical and radiological outcomes between the two groups

Study Type

Interventional

Enrollment (Actual)

40

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
      • Sohag, Egypt
        • Sohag University 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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pediatric patient
  • aging from 4 to 15 years old
  • diaphyseal ulnar fracture
  • either isolated or combined with radius fracture (both bone).

Exclusion Criteria:

  • Segmental fractures
  • Montaggia variants
  • Gelliazzi fracture
  • Fractures associated with radial head fracture - Compound fractures
  • Fractures with neurovascular affection

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Antegrade intramedullary k wire group
k wire entry point is from the olecranon towards the hand before the distal ulnar styloid
Procedure: ulna shaft fracture fixation in children by intramedullary k wire
  • In the 1st group The Antegrade intramedullary k wire with appropriate diameter according to the child ulna diameter is introduced from the olecranon of the fractured ulna,cross the fracture site after good reduction under C arm in the anterioposterior and lateral views and the wire continues until reaching before the distal ulna .
  • In the 2nd group The Retrograde intramedullary k wire with appropriate diameter is introduced from the diatal end of the ulna and cross the fracture site after good reduction under C arm and continues until reaching before the olecranon.
Active Comparator: Retrograde intramedullary k wire group
k wire entry point is from the distal ulnar styloid towards the olecranon
Procedure: ulna shaft fracture fixation in children by intramedullary k wire
  • In the 1st group The Antegrade intramedullary k wire with appropriate diameter according to the child ulna diameter is introduced from the olecranon of the fractured ulna,cross the fracture site after good reduction under C arm in the anterioposterior and lateral views and the wire continues until reaching before the distal ulna .
  • In the 2nd group The Retrograde intramedullary k wire with appropriate diameter is introduced from the diatal end of the ulna and cross the fracture site after good reduction under C arm and continues until reaching before the olecranon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The duration of complete union of the bone in every group
Time Frame: The evaluation is done at 2,4,6 and 12 weeks and 3 months

Each patient is evaluated radiologically after fixing the fracture by x-ray AP and lateral views after 2 week ,4 ,6 ,12 weeks and 3 months to see the time each one taking to complete union .

-Also clinical and functional evaluation of every patient and timing of ability to use his forearm , ability to do supination and pronation of the forearm , flexion and extension of the elbow and wrist , ability to do ulnar deviation at the level of the wrist and degree of pain and apprehension with each movement ,Degree of pain and tenderness in the fracture site and time taking to complete disappearing of pain and tenderness ,degree of stiffness and need to physiotherapy ,these data is collected from each patient at the time of follow up in the outpatient clinic and recorded for everyone in each group.
The evaluation is done at 2,4,6 and 12 weeks and 3 months

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 (Actual)

January 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

December 31, 2024

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-12-01MS

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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