Sohag university hospital
Sohag, Egypt
Active, Not Recruiting
NCT Number: NCT06781684
Ulnar Shaft Fracture Fixation by Antegrade Versus Retrograde Intramedullary k Wires in Children
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
Active, Not Recruiting
This study is active but is not currently recruiting participants.
Notify MeKey information
Conditions
Age range
4 year–15 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
ulna shaft fracture fixation in children by intramedullary k wire
Procedure- 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.
Primary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Sohag University
Other
Registry information
Official study title
Ulnar Shaft Fracture Fixation by Antegrade Versus Retrograde Intramedullary k Wires in Children;A Comparative Study
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Jan 17, 2025
- Registry last updated
- Jan 17, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.