NCT06312995

Investigation of a Medical Device for the Immobilisation of Radius and Ulna Fractures in Paediatric Patients

Pre-market Clinical Investigation of a Medical Device for the Immobilisation of Radius and Ulna Fractures in Paediatric Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Meyer Children's Hospital IRCCS · Academic / Other
• Sex: All
• Age: 7 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

Single-centre, randomised, controlled, non-profit study on a custom-made medical device for immobilisation of radius and ulna fracture in paediatric patients. The aim of the study is to evaluate the benefits in terms of comfort, safety and efficacy resulting from the use of a customised 3D-printed wrist immobilisation device in children aged between 7 and 13 with a fracture of the distal metaphysis of radius or ulna of the 'green stick' type, compared to a control group treated with traditional immobilisation devices. The patients will be randomised between use of customised 3D- printed wrist immobilisisation device and plaster.

Detailed description

The device under investigation has already been the subject of a pilot study (clinical investigation code: T3DDY01) with significant result. These results are also preparatory to the proposed new investigation, which aims to extend its applicability to more complex clinical conditions. Compared to the previous one, the new study will be able to take advantage of an improved acquisition process of the anatomy of the child's upper limb, obtained by updating the model of the chambers used. The aim of the study is to evaluate the benefits in terms of comfort, safety and efficacy resulting from the use of a customised 3D-printed wrist immobilisation device in children aged between 7 and 13 with a fracture of the distal metaphysis of radius or ulna of the 'green stick' type, compared to a control group treated with traditional immobilisation devices. The patients will be randomised between use of customised 3D- printed wrist immobilisisation device and plaster.

Conditions

• Fractures, Bone

Interventions

Type	Name	Description
DEVICE	T3DDY01	Digital acquisition of the patient's forearm using Intel RealSense D415 cameras (CE devices certified according to EN/IEC 60825-1 2007 - Safety of Laser product as Class I Laser Devices, i.e., Non-Hazardous Laser Radiation). The patient's arm is placed on a support to allow the plaster nurse to position the wrist at the correct angle needed to treat the fracture.
DEVICE	PLASTER	Standard treatment plaster for fractures.

Timeline

• Start date: 2022-03-14
• Primary completion: 2025-02-14
• Completion: 2025-06-14
• First posted: 2024-03-15
• Last updated: 2024-03-15

Locations

1 site across 1 country: Italy