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

NCT ID: NCT06312995

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-14
• Study Completion Date: 2025-06-14

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

T3DDY01

Acquired a digital acquisition of the patient's forearm using the Intel RealSense D415. The arm of the patient' is placed on a support to allow the plaster nurse to position of the wrist at the correct angle to treat the fracture. The limb is temporarily immobilised in a plaster cast by the nurses of the practice. The patient is booked for a subsequent outpatient visit (which will be conducted within 72 hours of digital acquisition of the forearm) for the application of the device under investigation. The production of the device through a Stratasys F370 3D printer owned by the Meyer Children's Hospital IRCCS. The material used is ABS (Acrylonitrile butadiene styrene) supplied by Stratasys and specific to the machine. Placement of the device on the patient by the investigating nurses, after removal of the temporary device. Collection of data on the evaluation of study parameters.

Group Type: EXPERIMENTAL

T3DDY01

Intervention Type: DEVICE

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.

PLASTER

Traditional device placement (antibrachio-metacarpal cast). Radiological check at 7 days after trauma to verify the angle of the stumps fracture angle, followed by radiological check at 14 days if necessary . Removal of the plaster cast 30 days after the trauma, radiological check to verify the formation of bone callus, clinical evaluation and data collection at the end of treatment

Group Type: ACTIVE_COMPARATOR

PLASTER

Intervention Type: DEVICE

Standard treatment plaster for fractures.

Interventions

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.

Intervention Type: DEVICE

PLASTER

Standard treatment plaster for fractures.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meyer Children's Hospital IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Alessandro Zanardi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessandro Zanardi, MD

Role: PRINCIPAL_INVESTIGATOR

Meyer Children's Hospital IRCCS Locations: Italy

Locations

Meyer Children's Hospital IRCCS

Florence, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Alessandro Zanardi, MD

Role: CONTACT

alessandro.zanardi@meyer.it

055 5662908

Facility Contacts

Alessandro Zanardi, MD

Role: primary

alessadro.zanardi@meyer.it

055 5662908

Other Identifiers

T3DDY02

Identifier Type: -

Identifier Source: org_study_id