- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07162142
- Original Trial
Retrograde Elastic Nailing With Pollar K-wire in Metaphyseal Diaphyseal Fracture of Distal Radius in Pediatric Patients
August 29, 2025 updated by: abdalaziz youssef mohammed abdalhady, Al-Azhar University
Distal radius fractures are the most common fractures in the pediatric population .
It accounts for 35% of all pediatric fractures .
Although pediatric distal radius fractures can be successfully treated conservatively, reduction losses of 21-39% can be observed in the treatment with a plaster cast .
Reduction losses are frequently observed in distal radius diaphyseal metaphyseal junctional (DRDMJ) fractures, primarily due to the limited contact surface of the fracture .
There has yet to be a consensus regarding the treatment protocol for DRDMJ fractures .
In DRDMJ fractures, surgery is recommended in cases where satisfactory alignment cannot be achieved with closed re-duction and cast immobilization, or there is reduction loss in clinical follow-ups .
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
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
-
-
-
Cairo, Egypt
- Abdalaziz Youssef Mohammed
-
-
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
Yes
Description
Inclusion Criteria:
- all distal radial fractures in pediatric patients 3-15 years failed closed reduction
Exclusion Criteria:
- pathological fracture
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: metaphyseal diaphyseal fracture of distal radial fracture in pediatrics
|
retrograde elastic nailing of metaphyseal diaphyseal fracture of distal radius in pediatrics
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks
Time Frame: three months
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 1, 2024
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
February 8, 2025
First Submitted That Met QC Criteria
August 29, 2025
First Posted (Estimated)
September 9, 2025
Study Record Updates
Last Update Posted (Estimated)
September 9, 2025
Last Update Submitted That Met QC Criteria
August 29, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RENPKMDFDRP
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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