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Enrolling by invitation NCT06542471

Plating Versus Nailing in Pediatric BB Forearm Fractures

No phase Interventional Intramedullary Nail Plate Fixation Forearm Fracture Randomized Controlled Trial

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dual intramedullary nailing, Dual plating.
Who it may be relevant to
Registry conditions: Intramedullary Nail, Plate Fixation, Forearm Fracture, Randomized Controlled Trial. Basic parameters: from 9 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Dual Intramedullary Nailing Fixation Versus Dual Plating of Pediatric Both Bone Forearm Fracture: a Study Protocol for a Randomized Controlled Trial

Overview

A randomized controlled trial to compare between dual intramedullary nailing and dual plating trying to synthesis a high quality evidence study that can solve the conflict between the decisions.

Interventions

  • Device Dual intramedullary nailing
    \- Elastic nailing for radius under image guidance through distal entry point and physeal sparing technique.
  • Device Dual plating
    \- ORIF for radius done first through volar approach.

Primary outcome measures

  • Time to union [Time frame: 6 months]
  • Elbow range of motion [Time frame: 6 months]
  • Quick DASH score [Time frame: 6 months]
  • patient satisfaction questionnaire [Time frame: 6 months]
Secondary outcome measures (4)
  • Adverse events [Time frame: 6 months]
  • Re-operation rate [Time frame: 6 months]
  • size of wound scar in millimeters [Time frame: 6 months]
  • Deformity (malunion rate) [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Both-bone Forearm Diaphyseal Fracture.
  • age more than or equal nine years old with open distal radius physis.
  • Simple transverse or short oblique fractures (2R2-A2,2R2-A3,2U2-A2,2U2-A3) according to OTA/ AO classification.

Exclusion criteria

  • Neurovascular injury.
  • Open fractures
  • Comminuted fractures
  • Pathological fractures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Ain Shams University — Cairo

Identifiers

NCT: NCT06542471 · 23ew234

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗