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

NCT06312995 | Recruiting

• 1 other identifier: T3DDY02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures, Bone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Adverse event

  through study completetion, an average of 1 year

• Comfort of use of devices

  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

  During the tudy (at 30 days)

• Pain evaluation

  During the study (7, 30-day and FU)

• Acceptance of the device

  At 7 and 30 days from the use of the device

Study Arms (2)

T3DDY01

EXPERIMENTAL

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.

Device: T3DDY01

PLASTER

ACTIVE COMPARATOR

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

Device: PLASTER

Interventions

T3DDY01 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.

T3DDY01

PLASTER DEVICE

Standard treatment plaster for fractures.

PLASTER

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (1)

Meyer Children's Hospital IRCCS

Florence, 50139, Italy

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Interventions

Casts, Surgical

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Alessandro Zanardi, MD

  Meyer Children's Hospital IRCCS Locations: Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Zanardi, MD

CONTACT

055 5662908; alessandro.zanardi@meyer.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: March 15, 2024
• Study Start: March 14, 2022
• Primary Completion: February 14, 2025
• Study Completion: June 14, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

IT (1)