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Enrolling by Invitation

NCT Number: NCT06542471

Plating Versus Nailing in Pediatric BB Forearm Fractures

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.

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Key information

Conditions

Intramedullary Nail Forearm Fracture Plate Fixation Randomized Controlled Trial

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 11655, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual intramedullary nailing

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

Dual plating

Device
  • ORIF for radius done first through volar approach.

Primary outcomes

  1. Time to union

    Time frame: 6 months

    weeks required to achieve union

  2. Elbow range of motion

    Time frame: 6 months

    elbow flexion, extension, pronation and supination in degrees

  3. Quick DASH score

    Time frame: 6 months

    Patient reported questionnaire

  4. patient satisfaction questionnaire

    Time frame: 6 months

    five points Likert scale

Secondary outcomes

  1. Adverse events

    Time frame: 6 months

    Any adverse event will be recorded

  2. Re-operation rate

    Time frame: 6 months

    percentage of patients requiring reoperation

  3. size of wound scar in millimeters

    Time frame: 6 months

    measuring the size of wound scar in millimeters

  4. Deformity (malunion rate)

    Time frame: 6 months

    Malunion deformity

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: DINDPL

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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