Plating Versus Nailing in Pediatric BB Forearm Fractures (DINDPL)

August 3, 2024 updated by: Ain Shams University

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

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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

  • Egypt
      • Cairo, Egypt, 11655
        • Ain shams university

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
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1
Intramedullary nail group
Device: Dual intramedullary nailing
- Elastic nailing for radius under image guidance through distal entry point and physeal sparing technique.
Experimental: group 2
Plating group
Device: Dual plating
- ORIF for radius done first through volar approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to union
Time Frame: 6 months
weeks required to achieve union
6 months
Elbow range of motion
Time Frame: 6 months
elbow flexion, extension, pronation and supination in degrees
6 months
Quick DASH score
Time Frame: 6 months
Patient reported questionnaire
6 months
patient satisfaction questionnaire
Time Frame: 6 months
five points Likert scale
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 6 months
Any adverse event will be recorded
6 months
Re-operation rate
Time Frame: 6 months
percentage of patients requiring reoperation
6 months
size of wound scar in millimeters
Time Frame: 6 months
measuring the size of wound scar in millimeters
6 months
Deformity (malunion rate)
Time Frame: 6 months
Malunion deformity
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Mahmoud Mahran, MD, Ain shams university
  • Study Director: Ahmed Saeed Younis, Ain shams university
  • Principal Investigator: Abdelrahman Hani, Ain shams university

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 (Estimated)

August 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

July 6, 2024

First Submitted That Met QC Criteria

August 3, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23ew234

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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