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Clinical Trials/NCT06542471
NCT06542471
Enrolling By Invitation
Not 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 enrollmentAugust 1, 2024
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ConditionsIntramedullary NailPlate FixationForearm FractureRandomized Controlled Trial

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intramedullary Nail
Sponsor
Ain Shams University
Enrollment
60
Locations
1
Primary Endpoint
Elbow range of motion
Status
Enrolling By Invitation
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2024
End Date
September 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Elbow range of motion

Time Frame: 6 months

elbow flexion, extension, pronation and supination in degrees

Time to union

Time Frame: 6 months

weeks required to achieve union

Quick DASH score

Time Frame: 6 months

Patient reported questionnaire

patient satisfaction questionnaire

Time Frame: 6 months

five points Likert scale

Secondary Outcomes

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

Study Sites (1)

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