NCT04664517 Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft Fractures
| NCT ID | NCT04664517 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Helsinki University Central Hospital |
| Condition | Both Bone Forearm Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2021-05-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2021-05-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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
Contact & Investigator
Ilkka Helenius, MD
STUDY DIRECTOR
Helsinki University Central Hospital
Frequently Asked Questions
Who can join the NCT04664517 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 12 Years, studying Both Bone Forearm Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04664517 currently recruiting?
Yes, NCT04664517 is actively recruiting participants. Contact the research team at petra.grahn@hus.fi for enrollment information.
Where is the NCT04664517 trial being conducted?
This trial is being conducted at Helsinki, Finland, Kuopio, Finland, Oulu, Finland, Tampere, Finland and 1 additional location.
Who is sponsoring the NCT04664517 clinical trial?
NCT04664517 is sponsored by Helsinki University Central Hospital. The principal investigator is Ilkka Helenius, MD at Helsinki University Central Hospital. The trial plans to enroll 90 participants.