SplintsNCT04306796
3D Printed Made to Measure Splints for Hand Patients
A study testing 3D printed splints and Thermoplastic splints in people with Splints, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study aims to evaluate the feasibility and possible benefits of 3D-printed made to measure splints for postoperative or post-traumatic treatment in hand surgical patients (intervention group) in comparison to thermoplastic splints individually adjusted by occupational therapists (control group). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Splints
- What is being tested?
- 3D printed splints and Thermoplastic splints
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Aug 2019to 17 Feb 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting to the hand surgical department of the University Hospital Basel
- Patients with hand trauma w/wo the need for hand surgery or patient with planned elective hand surgical intervention
- Indication for immobilization of at least 4 weeks
- Older than 18 years
- Capable of consent
- Informed Consent as documented by signature
Who cannot join
- Open wounds with tissue loss
- Injury with the need for external fixation
- Younger than 18 years
- Not capable of consent
- Asymmetric deformity or loss of the contra-lateral hand
- Documented hypersensitivity or allergy to Polylactic acid
Show all 10Show fewer
- Known or suspected non-compliance to agreed treatment measures and/or unexcused nonappearance to hospital appointments
- Drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Previous enrolment into the current study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Klinik für Plastische, Rekonstruktive, Aesthetische und Handchirurgie,
Basel, 4035
About this study
Official title: 3D Printed Made to Measure Splints for Hand Patients - Pilot Feasibility Study and Socioeconomic Evaluation
This study aims to evaluate the feasibility and possible benefits of 3D-printed made to measure splints for postoperative or post-traumatic treatment in hand surgical patients (intervention group) in comparison to thermoplastic splints individually adjusted by occupational therapists (control group).
- Conditions
- Splints
- Being tested
- 3D printed splints, Thermoplastic splints
- Keywords
- hand trauma, splint, made to measure, 3D print
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed splintsDevice
3D printed made to measure splints
Thermoplastic splintsDevice
thermoplastic splints individually adjusted by occupational therapists
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Patients receiving 3D-printed made to measure splints for postoperative or post-traumatic treatment in hand surgical patients Receives: Device: 3D printed splints |
| control group | Active comparator | Patients receiving thermoplastic splints individually adjusted by occupational therapists Receives: Device: Thermoplastic splints |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient comfort and satisfaction
questionnaire 1. that will be filled out by the Patient (scale 1-10 and answer text with qualitative assessment)
Measured: at 2-5 days after trauma and/or surgery
Change in patient comfort and satisfaction
questionnaire 2. that will be filled out by the Patient (scale 1-10 and answer text with qualitative assessment)
Measured: at 2 weeks of immobilization during a routine control visit
Change in patient comfort and satisfaction
questionnaire 3. that will be filled out by the Patient (scale 1-10 and answer text with qualitative assessment)
Measured: at 6 weeks of immobilization during what is usually the concluding visit of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start22 Aug 2019
- Primary completion17 Feb 2020
- Study completion17 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SplintsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306796
- Sponsor's protocol ID
- 2019-00351;ch20Kaempfen
- Other IDs
- 2019
- Status last verified
- Jun 2020
- First submitted
- 4 Mar 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printed Made to Measure Splints for Hand Patients - Pilot Feasibility Study and Socioeconomic Evaluation
- ClinicalTrials.gov ID
- NCT04306796
- Acronym / sponsor ID
- 2019-00351;ch20Kaempfen
- Conditions
- Splints
- Keywords
- hand trauma, splint, made to measure, 3D print
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 13 Mar 2020 (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.
This study aims to evaluate the feasibility and possible benefits of 3D-printed made to measure splints for postoperative or post-traumatic treatment in hand surgical patients (intervention group) in comparison to thermoplastic splints individually adjusted by occupational therapists (control group).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Device: 3D printed splintsPatients receiving 3D-printed made to measure splints for postoperative or post-traumatic treatment in hand surgical patients |
| control group | Active comparator | Device: Thermoplastic splintsPatients receiving thermoplastic splints individually adjusted by occupational therapists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients presenting to the hand surgical department of the University Hospital Basel
- Patients with hand trauma w/wo the need for hand surgery or patient with planned elective hand surgical intervention
- Indication for immobilization of at least 4 weeks
- Older than 18 years
- Capable of consent
Key exclusion criteria (10 listed)
- Open wounds with tissue loss
- Injury with the need for external fixation
- Younger than 18 years
- Not capable of consent
- Asymmetric deformity or loss of the contra-lateral hand
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 |
|---|---|---|
| 3D printed splints3D printed made to measure splints | Device | intervention group |
| Thermoplastic splintsthermoplastic splints individually adjusted by occupational therapists | Device | control group |
Primary outcome
Change in patient comfort and satisfaction
Time frame: at 2-5 days after trauma and/or surgery
questionnaire 1. that will be filled out by the Patient (scale 1-10 and answer text with qualitative assessment)
Change in patient comfort and satisfaction
Time frame: at 2 weeks of immobilization during a routine control visit
questionnaire 2. that will be filled out by the Patient (scale 1-10 and answer text with qualitative assessment)
Change in patient comfort and satisfaction
Time frame: at 6 weeks of immobilization during what is usually the concluding visit of treatment
questionnaire 3. that will be filled out by the Patient (scale 1-10 and answer text with qualitative assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed splints and Thermoplastic splints in people with Splints, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 6 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: finished, as of the sponsor's last update on 16 Jun 2020. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient comfort and satisfaction (time frame: at 2-5 days after trauma and/or surgery). The study lists 3 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 16 Jun 2020; AzTrials last refreshed its copy on 31 Oct 2026.