CClinicalTrials.gg
Active, not recruitingNCT06781684Updated Jan 17, 2025

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

An interventional study of ulna shaft fracture fixation in children by intramedullary k wire in Fracture of Ulna Shaft, sponsored by Sohag University. Active, not recruiting at 1 site in Egypt. Open to participants aged 4 Years to 15 Years. Per ClinicalTrials.gov, last updated 2025-01-17.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as active, not recruiting.
  • Registered 11 months after the study started (first participant enrolled Jan 2024, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
4 Years to 15 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Fracture of Ulna Shaft

Browse trials for

Keywords

  • Fixation of pediatric ulna shaft fracture
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 40 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Segmental fractures
  • Montaggia variants
  • Gelliazzi fracture
  • Fractures associated with radial head fracture - Compound fractures
  • Fractures with neurovascular affection
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Procedureulna 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.

06

What researchers measure

Primary outcomes

  1. The duration of complete union of the bone in every group

    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.

    Time frame: The evaluation is done at 2,4,6 and 12 weeks and 3 months

07

Study locations

1 site
  • Sohag university hospital
    Sohag, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06781684
Lead sponsor
Sohag University
Responsible party
Mahmoud Ahmed Ali (Orthopedic Resident at sohag university hospital, Sohag University) — Principal investigator
First posted
Jan 17, 2025
Start date
Jan 1, 2024
Primary completion
Mar 1, 2025 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Jan 17, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion