Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft Fractures

Last updated: September 5, 2024
Sponsor: Helsinki University Central Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Reduction auder general anesthesia and long arm cast

Flexible intramedullary nail (FIN)

Clinical Study ID

NCT04664517
78/1801/2020
  • Ages 7-12
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 7 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

Exclusion Criteria:

  • 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

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Reduction auder general anesthesia and long arm cast
Phase:
Study Start date:
May 01, 2021
Estimated Completion Date:
December 31, 2024

Study Description

This is a multicenter, randomized superiority trial comparing closed reduction and cast immobilization to flexible intramedullary nails in 7-12 year old children with > 10° of angulation and/or > 10mm of shortening in displaced both bone forearm shaft fractures (AO-pediatric classification: 22D/2.1-5.2). A total of 78 patients with minimum 2 years of expected growth left are randomized in 1:1 ratio to either treatment group. The study has a parallel non-randomized patient preference arm. Both treatments are performed under general anesthesia. In the cast group a long arm cast is applied for 6 weeks. The flexible intramedullary nail group is immobilized in a collar and cuff sling for 4 weeks. Data is collected at baseline and at each follow-up until 1 year.

Primary outcome is 1) PROMIS Pediatric Item Bank v2.0 - Upper Extremity and 2) forearm pronation-supination range of motion at one-year follow-up. Secondary outcomes are Quick DASH, Pediatric pain questionnaire, Cosmetic VAS, wrist range of motion as well as any complications (malunion, delayed union, non-union or deep wound infection, peripheral nerve injury, need for re-intervention during 1-year follow-up) and costs of treatment.

The investigators hypothesize that flexible intramedullary nailing results in a superior outcome.

Connect with a study center

  • HUS New Childrens Hospital

    Helsinki, 00029HUS
    Finland

    Active - Recruiting

  • Kuopio University Hospital

    Kuopio,
    Finland

    Active - Recruiting

  • Oulu University Hospital

    Oulu,
    Finland

    Site Not Available

  • Tampere University Hospital

    Tampere,
    Finland

    Site Not Available

  • Turku University Hospital

    Turku,
    Finland

    Active - Recruiting

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