Fractures, BoneT3DDY02NCT06312995
Investigation of a Medical Device for the Immobilisation of Radius and Ulna Fractures in Paediatric Patients
A study testing T3DDY01 and PLASTER in people with Fractures, Bone, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Fractures, Bone
- What is being tested?
- T3DDY01 and PLASTER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 14 Mar 2022to 14 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Meyer Children's Hospital IRCCS
Florence, 50139
Alessandro Zanardi, MD, 055 5662908, alessadro.zanardi@meyer.it
About this study
Official title: Pre-market Clinical Investigation of a Medical Device for the Immobilisation of Radius and Ulna Fractures in Paediatric Patients
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.
Read the 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
- Being tested
- T3DDY01, PLASTER
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T3DDY01Device
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.
PLASTERDevice
Standard treatment plaster for fractures.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: PLASTER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 7 and 30 day from the use of the device
Secondary outcomes (7)
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.
Measured: 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
Measured: 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)
Measured: 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')
Measured: 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
Measured: 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.
Measured: 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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start14 Mar 2022
- Primary completion14 Feb 2025 (estimated)
- Study completion14 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Zanardi, Meyer Children's Hospital IRCCS
- Investigators
- Alessandro Zanardi, MD, Principal investigator, Meyer Children's Hospital IRCCS Locations: Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312995
- Sponsor's protocol ID
- T3DDY02
- Acronym
- T3DDY02
- Status last verified
- Mar 2024
- First submitted
- 13 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-market Clinical Investigation of a Medical Device for the Immobilisation of Radius and Ulna Fractures in Paediatric Patients
- ClinicalTrials.gov ID
- NCT06312995
- Acronym / sponsor ID
- T3DDY02 / T3DDY02
- Conditions
- Fractures, Bone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 14 Feb 2025 (estimated)
- Study completion
- 14 Jun 2025 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T3DDY01 | Experimental | Device: T3DDY01Acquired 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. |
| PLASTER | Active comparator | Device: PLASTERTraditional 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 |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T3DDY01Digital 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. | Device | T3DDY01 |
| PLASTERStandard treatment plaster for fractures. | Device | PLASTER |
Primary outcome
Fracture Healing
Time frame: At 7 and 30 day from the use of the device
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.
7 secondary outcomes
Adverse event
Time frame: through study completetion, an average of 1 year
Comfort of use of devices
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
Time frame: During the tudy (at 30 days)
Pain evaluation
Time frame: During the study (7, 30-day and FU)
Acceptance of the device
Time frame: At 7 and 30 days from the use of the device
Structural analysis of devices
Time frame: 30 days After the start of the treatment
Usability for design purposes of the controlate
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Zanardi, MD principal investigator
Meyer Children's Hospital IRCCS Locations: Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T3DDY01 and PLASTER in people with Fractures, Bone, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Zanardi, MD (055 5662908, alessandro.zanardi@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture Healing (time frame: At 7 and 30 day from the use of the device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.