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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
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.
Standard treatment plaster for fractures.
Meyer Children's Hospital IRCCS
Florence, Italy
RECRUITINGFracture Healing
Completion of the therapeutic course, i.e. fracture healing without intervention following immobilisation device placement with residual angulation \< 20°. Radiographic assessment of the fracture angle at 7 and 30 days after application of the device application; * Radiographic assessment of fracture healing at 30 days, defined as presence of bone callus on 3 out of 4 fracture margins; * If at the 7-day assessment the fracture angle appears critical, defined as \>15° or an increase \>5° from the initial radiograph, the patient will undergo a further radiographic assessment after a further 7 days (i.e. 14 days from the start of treatment). * Functional recovery of the limb will be investigated with a clinical examination 30 days after removal of the device (60 from the start of treatment), where arc of motion and elective pain and painability to active mobilisation, as per normal clinical practice.
Time frame: At 7 and 30 day from the use of the device
Adverse event
Recording at each assessment time of any adverse events such as: mobilisation of the device, appearance of peripheral deficits, intolerance expressed by the patient towards the device.
Time frame: through study completetion, an average of 1 year
Comfort of use of devices
Administration of the Comfort Rating Scale. The comfort rating scales (CRS) measure wearable comfort across 6 dimensions. These dimensions are Emotion, Attachment, Harm, Perceived change, Movement and Anxiety. Each parameter has a 21 point scale which are scored from 0 (low) to 20 (high) Emotion description: I am worried about how I look when I wear this device. I feel tense or on edge because I am wearing the device. Attachment description: I can feel the device on my body. I can feel the device moving. Harm description: The device is causing me some harm. The device is painful to wear. Perceived change description: Wearing the device makes me feel physically different. I feel strange wearing the device. Movement description: The device affects the way I move. The device inhibits or restricts my movement. Anxiety description: I do not feel secure wearing the device
Time frame: During the study (at 7 and 30 days from the use of the device)
Presence of skin lesions or other manifestations of intolerance to the device
Presence of skin lesions or other manifestations of intolerance to the device: scale NPUAP/EPUAP (European Pressure Ulcer Advisory Panel) at 30 days scale NPUAP/EPUAP : min(Category I: Non-bleaching erythema), max (Category IV: Full thickness tissue loss)
Time frame: During the tudy (at 30 days)
Pain evaluation
Pain assessment with VAS ( Visual Analogue Scale) scale at 7- and 30-day follow-up (FU) VAS SCALE: 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Time frame: During the study (7, 30-day and FU)
Acceptance of the device
dedicated Likaert scale administered at 7 and 30 days, only to parents for patients \< 10 years, to parents and patients for age \> 10 years Likaert scale: measure opinions, attitudes, or behaviors. It consists of a statement or a question, followed by a series of five or seven answer statements
Time frame: At 7 and 30 days from the use of the device
Structural analysis of devices
Structural analysis of the newly manufactured device and at the end of treatment: macroscopic visual analysis to assess the global and local integrity of the device, performed by study nurse.
Time frame: 30 days After the start of the treatment
Usability for design purposes of the controlate
Usability for planning purposes of the contralateral anatomical segment: superposition of the two models (mirroring+recording) and calculation of the deviation as point-to-point distance
Time frame: Through study completion, an average of 1 year
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