Using a custom 3D-printed device to treat wrist fractures in children
Pre-market Clinical Investigation of a Medical Device for the Immobilisation of Radius and Ulna Fractures in Paediatric Patients
This study tests a new 3D-printed wrist device to see if it works better and is more comfortable than regular plaster casts for kids aged 7 to 13 with certain wrist fractures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 7 Years to 13 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 1 site (Florence) |
| Trial ID | NCT06312995 on ClinicalTrials.gov |
What this trial studies
This study evaluates a custom-made 3D-printed wrist immobilisation device for children aged 7 to 13 with 'green stick' fractures of the radius or ulna. It is a single-centre, randomised, controlled trial comparing the new device to traditional plaster casts. The focus is on assessing comfort, safety, and efficacy in immobilising the fractures. The study builds on previous pilot results and aims to refine the device's design based on improved anatomical modeling.
Who should consider this trial
Good fit: Ideal candidates are children aged 7 to 13 with specific types of wrist fractures that meet the inclusion criteria.
Not a fit: Patients with complete or open fractures, polytrauma, or other specified conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance comfort and safety for pediatric patients with wrist fractures.
How similar studies have performed: Previous pilot studies have shown significant results, indicating potential for success in this new investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged between 7 and 13 years with compound fracture of the distal metaphysis of radius and/or ulna at "green wood" and initial angulation \<20°; * Informed consent obtained. Exclusion Criteria: * Complete fracture of radius and ulna; * Open fracture of radius and ulna; * Polytrauma, polyfracture; * Presence of neurovascular deficit at presentation; * Presence of underlying bone disease; * Presence of acute or chronic skin disorders; * Psycho-behavioural disorders; * Presence of ≥1 skin lesions according to NPUAP/EPUAP classification; * Specific allergies related to the materials used in the tested device; * Inability to perform follow-up examinations.
Where this trial is running
Florence
- Meyer Children's Hospital IRCCS — Florence, Italy (Recruiting)
Study contacts
- Principal investigator: Alessandro Zanardi, MD — Meyer Children's Hospital IRCCS Locations: Italy
- Study coordinator: Alessandro Zanardi, MD
- Email: alessandro.zanardi@meyer.it
- Phone: 055 5662908
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.