RecruitingNot ApplicableNCT04664517

Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft Fractures

Casting Versus Flexible Intramedullary Nailing in Displaced Forearm Shaft Fractures in 7 to 12 Years Old Children: A Study Protocol for a Randomized Controlled Trial


Sponsor

Helsinki University Central Hospital

Enrollment

90 participants

Start Date

May 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The forearm is the most common fracture location in children, with an increasing incidence. Displaced forearm shaft fractures have traditionally been treated with closed reduction and cast immobilization. Diaphyseal fractures in children have poor remodeling capacity, and malunion can thus cause permanent cosmetic and functional disability. Internal fixation especially with flexible intramedullary nails has gained increasing popularity, without evidence of a better outcome compared to closed reduction and cast immobilization.


Eligibility

Min Age: 7 YearsMax Age: 12 Years

Inclusion Criteria5

  • to12 year old children
  • Open distal radial physis
  • Both bone forearm shaft fractures (AO-pediatric classification: 22D/2.1-5.2)
  • More than 10 degrees of angulation
  • with or without less than 10mm of shortening

Exclusion Criteria6

  • Patients with bilateral fractures
  • Gustilo-Anderson grade I-III open fracture
  • Neurovascular deficit
  • Compartment syndrome
  • Pathologic fracture
  • Patient not able to give a written informed consent

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Interventions

PROCEDUREFlexible intramedullary nail (FIN)

Both bone FIN

PROCEDUREReduction auder general anesthesia and long arm cast

Reduction and cast


Locations(5)

HUS New Childrens Hospital

Helsinki, Finland

Kuopio University Hospital

Kuopio, Finland

Oulu University Hospital

Oulu, Finland

Tampere University Hospital

Tampere, Finland

Turku University Hospital

Turku, Finland

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NCT04664517