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

Fractures, Bone Clinical Trial

— T3DDY02  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06312995
• Other study ID #: T3DDY02
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: June 14, 2025

Study information

• Verified date: March 2024
• Source: Meyer Children's Hospital IRCCS
• Contact: Alessandro Zanardi, MD
• Phone: 055 5662908
• Email: alessandro.zanardi[@]meyer.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 14, 2025
• Est. primary completion date: February 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Ulna Fractures

Intervention

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.
• PLASTER
Standard treatment plaster for fractures.

Locations

Country	Name	City	State
Italy	Meyer Children's Hospital IRCCS	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Meyer Children's Hospital IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fracture 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.	At 7 and 30 day from the use of the device
Secondary	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.	through study completetion, an average of 1 year
Secondary	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	During the study (at 7 and 30 days from the use of the device)
Secondary	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)	During the tudy (at 30 days)
Secondary	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')	During the study (7, 30-day and FU)
Secondary	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	At 7 and 30 days from the use of the device
Secondary	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.	30 days After the start of the treatment
Secondary	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	Through study completion, an average of 1 year