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Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft Fractures

NCT04664517 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Both Bone Forearm Fracture
  • AO Classification 22D/2.1-5.2
  • 7-12 Year Old

Interventions

PROCEDURE

Flexible intramedullary nail (FIN)

Both bone FIN

PROCEDURE

Reduction auder general anesthesia and long arm cast

Reduction and cast

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Ilkka Helenius, MD · Helsinki University Central Hospital

  • Petra Grahn, MD · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04664517 on ClinicalTrials.gov