Plating Versus Nailing in Pediatric BB Forearm Fractures

N/AEnrolling By InvitationNCT06542471

Ain Shams University60 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Intramedullary Nail Plate Fixation Forearm Fracture Randomized Controlled Trial

Interventions

Dual intramedullary nailingDEVICE

\- Elastic nailing for radius under image guidance through distal entry point and physeal sparing technique.

Dual platingDEVICE

\- ORIF for radius done first through volar approach.

Eligibility

Sex: ALLMin age: 9 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Both-bone Forearm Diaphyseal Fracture. 2. age more than or equal nine years old with open distal radius physis. 3. Simple transverse or short oblique fractures (2R2-A2,2R2-A3,2U2-A2,2U2-A3) according to OTA/ AO classification. Exclusion criteria: 1. Neurovascular injury. 2. Open fractures 3. Comminuted fractures 4. Pathological fractures

Locations (1)

Ain Shams University

Cairo, Egypt

Outcomes

Primary Outcomes

Time to union

weeks required to achieve union

Time frame: 6 months

Elbow range of motion

elbow flexion, extension, pronation and supination in degrees

Time frame: 6 months

Quick DASH score

Patient reported questionnaire

Time frame: 6 months

patient satisfaction questionnaire

five points Likert scale

Time frame: 6 months

Secondary Outcomes

Adverse events

Any adverse event will be recorded

Time frame: 6 months

Re-operation rate

percentage of patients requiring reoperation

Time frame: 6 months

size of wound scar in millimeters

measuring the size of wound scar in millimeters

Time frame: 6 months

Deformity (malunion rate)

Malunion deformity

Time frame: 6 months

Data from ClinicalTrials.gov

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