Distal Radius Fractures3DxSPLINTNCT05902442
A Clinical Comparison of Patient-specific 3D Printed Splints Versus Conventional Splints in the Treatment of Distal Radius Fractures.
A study testing 3DxSPLINT in people with Distal Radius Fractures, run by Radboud University Medical Center.
Trial summary
The goal of this clinical trial is to assess patient reported outcome measures of adult patients who are diagnosed with a distal radius fracture and treated with a patient-specific 3D printed splint as compared to a control cohort. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- 3DxSPLINT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 Dec 2023
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 16 years or older
- Admitted to the emergency department or plaster room with a DRF
- Non-operative treatment with cast immobilization
- Written informed consent
- Patients must be able to follow the study protocol
Who cannot join
- Operative treatment
- Open fractures
- History of surgically treated wrist fracture on the currently injured side within the last year (≤ 1 year)
- Unable to wear conventional forearm splint due to medical condition, known allergies or other reasons
- (partially) paralysis of the affected arm
- DRF older than two weeks
Trial locations and contacts
No sites are listed yet.
L.A. van Ginkel contact
About this study
The goal of this clinical trial is to assess patient reported outcome measures of adult patients who are diagnosed with a distal radius fracture and treated with a patient-specific 3D printed splint as compared to a control cohort.
Patients receive routine immobilization procedure with a patient-specific 3D printed splint instead of the use of a conventional forearm splint after one week of conventional immobilization.
The main study parameters are patient reported outcome measures related to comfort and satisfaction of the medical aid. This will be measured qualitatively with a semi-structured interview and quantitively using questionnaires.
Read the detailed description
Distal radius fracture (DRF) is a very common injury of the upper extremity. Yearly, over 45,000 patients visit the outpatient clinic with a DRF in the Netherlands. One third of these fractures are non-displaced and two thirds are displaced fractures. The conservative treatment of DRFs includes immobilization of the injured extremity using a conventional forearm cast. These casts do cause all sorts of discomfort during wear and impose life-style restrictions on the wearer. Examples are irritation and itching of the skin, pain from pressure points and inability to shower or swim without a protective sleeve. Emergent three-dimensional (3D) technology enables patient-specific splint design and fabrication. These splints are custom made to accurately fit the individual patient. The material of 3D printed splints is considered lightweight. Moreover, 3D splint design allows an open structure resulting in more ventilation, offering better hygiene and the possibility for wound control. The production of 3D splints can be accomplished with several hardware and software combination. The production process is similar overall and requires several steps. First image data with 3D spatial information of the limb is captured with either a 3D scanner or medical imaging device. The design of the 3D printed splint is further developed using a software application. The 3D splints design data is then exported, and the physical splint is printed using a 3D printer. Depending on material and device characteristics, postprocessing steps are required. The splint may require removal of support, curing and smoothing. If applicable, a closure mechanism is applied.
Currently most implementations of custom made 3D printed splints happen within the framework of case series or feasibility studies. Some previous studies have described on clinical tests from patients with promising results. However, studies are heterogenous in the use of hardware, software, 3D splint design, print materials, fabrication time and costs. Moreover, clinical comparison with conventional interventions remain scare. Therefore, it is challenging to determine the impact of 3D printed splints intervention on the patient with injuries .
The goal of this clinical trial is to assess patient reported outcome measures of adult patients who are diagnosed with a DRF and treated with a patient- specific 3D printed splint as compared to a control cohort. The secondary objectives are:
- To define whether treatment of 3D printed splints of DRF's result in the same clinical outcomes compared to treatment with standard plaster cast .
- To investigate the safety of 3D printed splint treatment.
- To generate hypothesis which individual characteristics might be used to determine which patients can benefit most from 3D printed splint treatment.
- To investigate barriers and facilitators to implementation.
- Conditions
- Distal Radius Fractures
- Being tested
- 3DxSPLINT
- Keywords
- 3D printing technology, Cast, Splint, Immobilization, Nonoperative, Patient specific, Radius Fracture
- Medical subject headings
- Wrist Fractures, Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3DxSPLINTDevice
Routine immobilization procedure with a patient-specific 3D printed splint instead of the use of a conventional forearm splint after one week of conventional immobilization.
| Study group | Role | What they receive |
|---|---|---|
| 3DxSPLINT | Experimental | Not described Receives: Device: 3DxSPLINT |
What is being measured
The primary outcome is the main question the study is designed to answer.
D-QUEST
Instrument for measuring client satisfaction with a medical device. D-QUEST is a Dutch version of the Quebec User Evalutation of Satisfaction with assistive Technology.
Measured: three to five weeks post injury
CSD-OPUS
The Orthotics and Prosthetics User's Survey on the Satisfaction with Devices.
Measured: three to five weeks post injury
EQ-5D VAS
Rates the overall health of a patient.
Measured: three to five weeks post injury
Semi structured interview
Patient reported outcome measrues related to comfort and satisfaction of the medical aid. Issures discussed:limitations daily life, cosmetic look and local complicaitons.
Measured: three to five weeks post injury
Secondary outcomes (5)
PRWE
Questionnaire to measure patient rated pain and disability for wrist conditions.
Measured: Approximately, one week, three to five weeks and 3 months post injury.
Complications
McKay checklist is used for scoring the complications after distal radius fracture.
Measured: three months post injury.
Union rate
Union rate will be measured according to the current clinical standard.
Measured: One week to three months post injury
Safety outcomes
Reasons for withdrawal and adverse events (production- and wearing of the 3D printed splints) are registered and evaluated
Measured: one week to three months post injury
Barriers to implementation
Acceptance by caregivers and technical problems related to hardware- and software use in the 3D workflow are registered and evaluated.
Measured: one week to three months post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- V.M.A. Stirler, dr., Principal investigator, Department of Trauma Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902442
- Sponsor's protocol ID
- NL83500.091.22
- Acronym
- 3DxSPLINT
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparison of Patient-specific 3D Printed Splints Versus Conventional Splints in the Treatment of Distal Radius Fractures.
- ClinicalTrials.gov ID
- NCT05902442
- Acronym / sponsor ID
- 3DxSPLINT / NL83500.091.22
- Conditions
- Distal Radius Fractures
- Keywords
- 3D printing technology, Cast, Splint, Immobilization, Nonoperative, Patient specific, Radius Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Jun 2023 (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.
The goal of this clinical trial is to assess patient reported outcome measures of adult patients who are diagnosed with a distal radius fracture and treated with a patient-specific 3D printed splint as compared to a control cohort.
Patients receive routine immobilization procedure with a patient-specific 3D printed splint instead of the use of a conventional forearm splint after one week of conventional immobilization.
The main study parameters are patient reported outcome measures related to comfort and satisfaction of the medical aid. This will be measured qualitatively with a semi-structured interview and quantitively using questionnaires.
Detailed description
Distal radius fracture (DRF) is a very common injury of the upper extremity. Yearly, over 45,000 patients visit the outpatient clinic with a DRF in the Netherlands. One third of these fractures are non-displaced and two thirds are displaced fractures. The conservative treatment of DRFs includes immobilization of the injured extremity using a conventional forearm cast. These casts do cause all sorts of discomfort during wear and impose life-style restrictions on the wearer. Examples are irritation and itching of the skin, pain from pressure points and inability to shower or swim without a protective sleeve. Emergent three-dimensional (3D) technology enables patient-specific splint design and fabrication. These splints are custom made to accurately fit the individual patient. The material of 3D printed splints is considered lightweight. Moreover, 3D splint design allows an open structure resulting in more ventilation, offering better hygiene and the possibility for wound control. The production of 3D splints can be accomplished with several hardware and software combination. The production process is similar overall and requires several steps. First image data with 3D spatial information of the limb is captured with either a 3D scanner or medical imaging device. The design of the 3D printed splint is further developed using a software application. The 3D splints design data is then exported, and the physical splint is printed using a 3D printer. Depending on material and device characteristics, postprocessing steps are required. The splint may require removal of support, curing and smoothing. If applicable, a closure mechanism is applied.
Currently most implementations of custom made 3D printed splints happen within the framework of case series or feasibility studies. Some previous studies have described on clinical tests from patients with promising results. However, studies are heterogenous in the use of hardware, software, 3D splint design, print materials, fabrication time and costs. Moreover, clinical comparison with conventional interventions remain scare. Therefore, it is challenging to determine the impact of 3D printed splints intervention on the patient with injuries .
The goal of this clinical trial is to assess patient reported outcome measures of adult patients who are diagnosed with a DRF and treated with a patient- specific 3D printed splint as compared to a control cohort. The secondary objectives are:
- To define whether treatment of 3D printed splints of DRF's result in the same clinical outcomes compared to treatment with standard plaster cast .
- To investigate the safety of 3D printed splint treatment.
- To generate hypothesis which individual characteristics might be used to determine which patients can benefit most from 3D printed splint treatment.
- To investigate barriers and facilitators to implementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3DxSPLINT | Experimental | Device: 3DxSPLINT |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 16 years or older
- Admitted to the emergency department or plaster room with a DRF
- Non-operative treatment with cast immobilization
- Written informed consent
- Patients must be able to follow the study protocol
Key exclusion criteria (6 listed)
- Operative treatment
- Open fractures
- History of surgically treated wrist fracture on the currently injured side within the last year (≤ 1 year)
- Unable to wear conventional forearm splint due to medical condition, known allergies or other reasons
- (partially) paralysis of the affected arm
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 |
|---|---|---|
| 3DxSPLINTRoutine immobilization procedure with a patient-specific 3D printed splint instead of the use of a conventional forearm splint after one week of conventional immobilization. | Device | 3DxSPLINT |
Primary outcome
D-QUEST
Time frame: three to five weeks post injury
Instrument for measuring client satisfaction with a medical device. D-QUEST is a Dutch version of the Quebec User Evalutation of Satisfaction with assistive Technology.
CSD-OPUS
Time frame: three to five weeks post injury
The Orthotics and Prosthetics User's Survey on the Satisfaction with Devices.
EQ-5D VAS
Time frame: three to five weeks post injury
Rates the overall health of a patient.
Semi structured interview
Time frame: three to five weeks post injury
Patient reported outcome measrues related to comfort and satisfaction of the medical aid. Issures discussed:limitations daily life, cosmetic look and local complicaitons.
5 secondary outcomes
PRWE
Time frame: Approximately, one week, three to five weeks and 3 months post injury.
Complications
Time frame: three months post injury.
Union rate
Time frame: One week to three months post injury
Safety outcomes
Time frame: one week to three months post injury
Barriers to implementation
Time frame: one week to three months post injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
L.A. van Ginkel contact
V.M.A. Stirler, dr. principal investigator
Department of Trauma Surgery, Radboud University Medical Centre, Nijmegen, the Netherlands.
Questions about this trial
What is this clinical trial studying?
A study testing 3DxSPLINT in people with Distal Radius Fractures, run by Radboud University Medical Center.
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 5 inclusion and 6 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 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 V.M.A. Stirler, dr. (24361712 ext. +31, vincent.stirler@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
D-QUEST (time frame: three to five weeks post injury). The study lists 4 primary outcomes in all. 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 Jun 2023.