Comparing casting and flexible nailing for children's forearm 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
This study is testing whether a cast or a flexible nail works better for treating broken forearms in kids aged 7 to 12.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 7 Years to 12 Years |
| Sex | All |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 5 sites (Helsinki and 4 other locations) |
| Trial ID | NCT04664517 on ClinicalTrials.gov |
What this trial studies
This multicenter trial compares two treatment methods for displaced forearm shaft fractures in children aged 7 to 12. Participants will be randomly assigned to receive either closed reduction with cast immobilization or flexible intramedullary nailing. The study aims to evaluate the effectiveness of these treatments by measuring upper extremity function and range of motion over a one-year follow-up period. Data will also be collected on complications and treatment costs to assess overall outcomes.
Who should consider this trial
Good fit: Ideal candidates are children aged 7 to 12 with specific types of displaced forearm shaft fractures.
Not a fit: Patients with bilateral fractures, open fractures of higher grades, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for pediatric forearm fractures, potentially reducing complications and enhancing recovery.
How similar studies have performed: While flexible intramedullary nailing is gaining popularity, there is limited evidence from similar studies to confirm its superiority over traditional casting methods.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Helsinki and 4 other locations
- HUS New Childrens Hospital — Helsinki, Finland (Recruiting)
- Kuopio University Hospital — Kuopio, Finland (Recruiting)
- Oulu University Hospital — Oulu, Finland (Not_yet_recruiting)
- Tampere University Hospital — Tampere, Finland (Not_yet_recruiting)
- Turku University Hospital — Turku, Finland (Recruiting)
Study contacts
- Principal investigator: Petra Grahn, MD — Helsinki University Central Hospital
- Study coordinator: Petra Grahn, MD
- Email: petra.grahn@hus.fi
- Phone: +35894711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.