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Clinical Trials/NCT06542471
NCT06542471Enrolling By InvitationNot Applicable

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

Ain Shams University1 site in 1 country60 target enrollmentStarted: August 1, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
60
Locations
1
Primary Endpoint
patient satisfaction questionnaire
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
9 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

group 1

Experimental

Intramedullary nail group

Intervention: Dual intramedullary nailing (Device)

group 2

Experimental

Plating group

Intervention: Dual plating (Device)

Outcomes

Primary Outcomes

patient satisfaction questionnaire

Time Frame: 6 months

five points Likert scale

Time to union

Time Frame: 6 months

weeks required to achieve union

Elbow range of motion

Time Frame: 6 months

elbow flexion, extension, pronation and supination in degrees

Quick DASH score

Time Frame: 6 months

Patient reported questionnaire

Secondary Outcomes

  • size of wound scar in millimeters(6 months)
  • Adverse events(6 months)
  • Re-operation rate(6 months)
  • Deformity (malunion rate)(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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