Clinical trial NCT06312995: Investigation of a Medical Device for the Immobilisation of Radius and Ulna Fractures in Paediatric Patients
Official title: Pre-market Clinical Investigation of a Medical Device for the Immobilisation of Radius and Ulna Fractures in Paediatric Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fractures, Bone
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Fracture Healing
timeFrame: At 7 and 30 day from the use of the device
Secondary outcomes:
measure: Adverse event
timeFrame: through study completetion, an average of 1 year
measure: Comfort of use of devices
timeFrame: During the study (at 7 and 30 days from the use of the device)
measure: Presence of skin lesions or other manifestations of intolerance to the device
timeFrame: During the tudy (at 30 days)
measure: Pain evaluation
timeFrame: During the study (7, 30-day and FU)
measure: Acceptance of the device
timeFrame: At 7 and 30 days from the use of the device
measure: Structural analysis of devices
timeFrame: 30 days After the start of the treatment
measure: Usability for design purposes of the controlate
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Meyer Children's Hospital IRCCS
Study officials:
affiliation: Meyer Children's Hospital IRCCS Locations: Italy
name: Alessandro Zanardi, MD
role: PRINCIPAL_INVESTIGATOR
References: