Plating Versus Nailing in Pediatric BB Forearm Fractures

NCT ID: NCT06542471

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Intramedullary Nail Plate Fixation Forearm Fracture Randomized Controlled Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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group 1

Intramedullary nail group

Group Type EXPERIMENTAL

Dual intramedullary nailing

Intervention Type DEVICE

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

group 2

Plating group

Group Type EXPERIMENTAL

Dual plating

Intervention Type DEVICE

\- ORIF for radius done first through volar approach.

Interventions

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Dual intramedullary nailing

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

Intervention Type DEVICE

Dual plating

\- ORIF for radius done first through volar approach.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahmoud Mahran, MD

Role: STUDY_CHAIR

Ain Shams University

Ahmed Saeed Younis

Role: STUDY_DIRECTOR

Ain Shams University

Abdelrahman Hani

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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23ew234

Identifier Type: -

Identifier Source: org_study_id

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