Distal Radius Fracture3D-splintingNCT05075135
Acceptability and Safety of 3D Printed Wrist-based Splints
A study testing Swibrace 3D-splint and Plaster cast in people with Distal Radius Fracture and Scaphoid Fracture, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Non-invasiveness, avoidance of complications and comfort are important issues in the clinical management of conservatively treated distal radius and scaphoid fractures. To date, applying a plaster cast for approximately 6 weeks of immobilization is the gold standard. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture, Scaphoid Fracture
- What is being tested?
- Swibrace 3D-splint and Plaster cast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Aug 2021to 31 Jul 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent as documented by signature
- ≥ 18 years old
- Understanding of German language (written and oral)
- Showing up at the Inselspital Bern emergency department with a stable, nondisplaced distal radius or scaphoid fracture that classifies a conservative immobilization treatment (as decided by the present surgeon on duty)
Who cannot join
- Known or suspected non-compliance
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- < 18 years old
- Vulnerable persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability and Safety of 3D Printed Wrist-based Splints Compared to Plaster Casts for the Treatment of Non-surgical Distal Radius- and Scaphoid Fractures: a Randomized Feasibility Study.
Non-invasiveness, avoidance of complications and comfort are important issues in the clinical management of conservatively treated distal radius and scaphoid fractures. To date, applying a plaster cast for approximately 6 weeks of immobilization is the gold standard. However, new 3D-technologies such as the design of Patient Specific Anatomical Braces (PSAB) will lead to a new paradigm of treatment. Swibrace has developed such anatomical, light, elegant and yet resistant braces. First, the fractured limb is scanned, the data then sent to a specifically designed software, printed in a 3D-printer and finally sent to the hospital for the patient's fitting. As these PSAB have not yet been tested on patients, the primary purpose of this study is to evaluate whether patient satisfaction with a 3D-printed PSAB differs from the one of traditionally treated patients in a plaster cast.
(A pre-clinical study will be conducted with 10 healthy volunteers testing the 3D splint for 72h. Only if splint satisfaction will be ≥ 70% as measured by the self-designed "Adult Rated Splint Evaluation Questionnaire" (ARSEQ), the 3D splint will be tested in patients. Otherwise, adjustments to the splint will be made based on the healthy volunteers' feedback prior to its testing in patients.)
Read the detailed description
A criteria sample of 10 adult patients per group (Swibrace 3D splint and plaster cast) will be recruited in one University hospital in Switzerland and randomly assigned to either the 3D-splint or plaster cast group.
(For the pre-clinical study, the investigators aim to recruit 10 healthy volunteers testing one of the two 3D splint models (radius or scaphoid fracture splint).)
Study intervention:
Patients wear the Swibrace 3D splint for 6 weeks of immobilization of the wrist for distal radius fractures, including the basis of the thumb for scaphoid fractures. X-rays after week 1, 3 and 6 are planned to document bone healing, together with weekly visits at the hand therapy unit to measure patient satisfaction and hand function. This results in 2-3 surgeon and 6 hand therapy visits at the Inselspital Bern, where regular check-ups on the patient's comfort in the splint are made.
The control intervention is the same as the study intervention, but the participants wear the "gold-standard" plaster cast instead of the newly designed Swibrace 3D-splint. For the pre-clinical study, there is no control intervention.
(Healthy volunteers wear the Swibrace 3D splint for 72 hours. During this time, they are allowed to use their splinted hand for their usual daily activities, except for driving a car. They note their activities in a diary. At the end of the splint wearing time, they complete the ARSEQ. The scanning procedure will take at a place convenient for the volunteers.)
Study objectives:
The primary objective of this study is to assess if the patients' personal experiences and perceptions of safety and satisfaction (as defined by the self-designed "Patient rated splint evaluation questionnaire" (PRSEQ)) are superior in the Swibrace PSAB compared to a custom-made plaster cast.
Secondary objectives are:
To examine if there is a significant difference in self-perceived hand function and pain between the two groups (as assessed by the self-designed "Patient rated splint evaluation questionnaire" (PRSEQ)) To assess if radiological parameters between groups are similar at the end of the splint wearing period.
(To evaluate satisfaction with the 3D splint in healthy volunteers before testing the 3D splint in patients.)
The safety objectives are:
To document the attrition rate and - if applicable - reasons for drop-out in the Swibrace PSAB group (drop-out means that the participants make a cross-over to the control group until bone healing is assured) during the splint wearing time.
The X-ray appointments at Inselspital Bern, checking for the bone's correct healing position
The patients' safety perception (as assessed by the self-designed PRSEQ)
- Conditions
- Distal Radius Fracture, Scaphoid Fracture
- Being tested
- Swibrace 3D-splint, Plaster cast
- Keywords
- 3D-splinting, Plaster cast, Patient satisfaction, Distal radius fracture, Scaphoid fracture
- Medical subject headings
- Wrist Fractures, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swibrace 3D-splintDevice
The Swibrace 3D splint is a custom-made splint. For scanning of the forearms, the investigators will use the scanner "HandySCAN300" and the therewith delivered software "VXElements", the latter being necessary to create an accurate scan on the computer.
Printing of the splint will be done by "Materialise", Belgium.
Plaster castDevice
The conservative gold standard treatment of distal radius and scaphoid fractures is applying a plaster cast. Therefore, patients in the control group follow standard therapy procedures.
| Study group | Role | What they receive |
|---|---|---|
| 3D-splint group | Experimental | Patients wear the Swibrace 3D splint for 6 weeks of immobilization of the wrist for distal radius fractures, including the basis of the thumb for scaphoid fractures. X-rays after week 1, 3 and 6 are planned to document bone healing, together with weekly visits at the hand therapy unit to measure patient satisfaction and hand function. This results in 2-3 surgeon and 6 hand therapy visits at the Inselspital Bern, where regular check-ups on the patient's comfort in the splint are made. Receives: Device: Swibrace 3D-splint |
| Plaster cast group | Active comparator | The control intervention is the same as the study intervention, but the participants wear the "gold-standard" plaster cast instead of the newly designed Swibrace 3D-splint. Receives: Device: Plaster cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in "Patient Reported Splint Evaluation Questionnaire (PRSEQ)"
The investigators designed this questionnaire to the best of their knowledge due to lack of pre-existing orthosis satisfaction questionnaires suitable for the study purposes. The PRSEQ will be completed by the participating patients. It consists of two parts:
Part 1 consist of 5 main topics: (1) pain because of the splint, (2) personal experiences with the splint, (3) personal safety, (4) specific and (5) usual activities in the splint. Pictures from the splint are given to allow ticking pressure marks and skin irritations where they appeared.
Part 2 consists of 3 main topics: (6) satisfaction with the splint, (7) personal attitude and (8) satisfaction with the scanning procedure. Each main topic includes several sub-questions, where the patient rates his/her answers on a 11-point-Likert scale (0-10).
Measured: Part 1 will be filled out during (at week 2, 4, 6) and Part 2 after the splint wearing time (week 6).
Secondary outcomes (7)
Hand therapy evaluation - applying the "assessment of patient satisfaction"
The assessment of patient satisfaction consists of 4 domains (patient comfort, patient compliance, cast odor and smell, skin itchiness) being rated on a 0-3 Likert Scale (0 = poor, 3 = excellent) by specialized hand therapists.
Measured: Assessed during 6 hand therapy visits on a weekly basis until week 6, starting in week 1
Hand therapy evaluation - finger range of motion as assessed by a hand-held goniometer
The hand-held goniometer will be used to measure the distances between the finger tips and the palm of the hand in centimeters. A touch-down (finger tips touch the palm) will be judged with "yes/no". Both finger range of motion measurements will be assessed by specialized hand therapists.
Measured: Assessed during 6 hand therapy visits on a weekly basis until week 6, starting in week 1
Hand therapy evaluation - sensibility as measured by the "Ten Test"
Specialized hand therapists will assess sensibility by applying the quantitative sensory test "Ten Test". The patient reports his/her light touch perception of the skin area being tested compared to the reference normal area when the examiner (hand therapist) gives a simultaneous stimulus by stroking a normal area and the area under examination. The response from the patient rating the sensibility of the test area is recorded as a fraction out of 10 between 1/10 and 10/10 (10 = normal sensory perception).
Measured: Assessed during 6 hand therapy visits on a weekly basis until week 6, starting in week 1
Hand therapy evaluation - pain as measured by the "Numeric Rating Scale"
Specialized hand therapists will assess pain using the Numeric Rating Scale for pain. It requires the patient to rate their pain on a defined scale from 0-10, where 0 is no pain and 10 is the worst pain imaginable. Patients are asked to circle their current pain in their hand on this scale.
Measured: Assessed during 6 hand therapy visits on a weekly basis until week 6, starting in week 1
Bone position - x-ray evaluation by specialized hand surgeons and orthopedists
Bone healing process is closely monitored by specialized hand surgeons and orthopedists by taking an x-ray on several time points:
- one week after the accident to check if the bone is not displaced to guarantee that a conservative treatment may be continued. in case of any uncertainties, another x-ray will take place during week 2 after the accident to check on the bone's position again.
- after 6 weeks, the last x-ray will be made to decide removal of the plaster cast / 3D splint
Measured: 2-3 regular x-rays will take place during the bone healing phase after 1 week of splint wearing, if necessary in week 2 and after 6 weeks as assessed by physicians
Questionnaire "assessment of clinical effectiveness" as rated by specialized hand surgeons and orthopedists
The "assessment of clinical effectiveness" is an assessment where 4 domains are judged by specialized hand surgeons or orthopedists on a 0-3 Likert Scale (0 = poor, 3 = excellent). These are: stability of immobilization, blood circulation, wear pressure-related pain and pressure sores.
Measured: Administered once at the end of the study after 6 weeks
Composite endpoint "adherence" assessed as the "number of clinical visits that were missed" / "number of drop-outs" and "number of patients crossing over to the plaster cast group"
Adherence will be documented by clinicians (hand therapists and physicians) in terms of counts of: clinical visits that have taken place (or being missed), drop-out or cross-over rates to the plaster cast group.
Measured: Ongoing during the whole study period of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start9 Aug 2021
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization is based on a single allocation ratio of 1:1 In order to generate an unpredictable allocation sequence and concealment of that sequence until assignment occurs, sequentially numbered, sealed, opaque envelopes will be prepared.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esther Vögelin, Prof, Study director, Department of Plastic and Hand Surgery (DOPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075135
- Sponsor's protocol ID
- 2021-00112
- Acronym
- 3D-splinting
- Status last verified
- Nov 2023
- First submitted
- 14 Sep 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Safety of 3D Printed Wrist-based Splints Compared to Plaster Casts for the Treatment of Non-surgical Distal Radius- and Scaphoid Fractures: a Randomized Feasibility Study.
- ClinicalTrials.gov ID
- NCT05075135
- Acronym / sponsor ID
- 3D-splinting / 2021-00112
- Conditions
- Distal Radius Fracture, Scaphoid Fracture
- Keywords
- 3D-splinting, Plaster cast, Patient satisfaction, Distal radius fracture, Scaphoid fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 12 Oct 2021 (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.
Non-invasiveness, avoidance of complications and comfort are important issues in the clinical management of conservatively treated distal radius and scaphoid fractures. To date, applying a plaster cast for approximately 6 weeks of immobilization is the gold standard. However, new 3D-technologies such as the design of Patient Specific Anatomical Braces (PSAB) will lead to a new paradigm of treatment. Swibrace has developed such anatomical, light, elegant and yet resistant braces. First, the fractured limb is scanned, the data then sent to a specifically designed software, printed in a 3D-printer and finally sent to the hospital for the patient's fitting. As these PSAB have not yet been tested on patients, the primary purpose of this study is to evaluate whether patient satisfaction with a 3D-printed PSAB differs from the one of traditionally treated patients in a plaster cast.
(A pre-clinical study will be conducted with 10 healthy volunteers testing the 3D splint for 72h. Only if splint satisfaction will be ≥ 70% as measured by the self-designed "Adult Rated Splint Evaluation Questionnaire" (ARSEQ), the 3D splint will be tested in patients. Otherwise, adjustments to the splint will be made based on the healthy volunteers' feedback prior to its testing in patients.)
Detailed description
A criteria sample of 10 adult patients per group (Swibrace 3D splint and plaster cast) will be recruited in one University hospital in Switzerland and randomly assigned to either the 3D-splint or plaster cast group.
(For the pre-clinical study, the investigators aim to recruit 10 healthy volunteers testing one of the two 3D splint models (radius or scaphoid fracture splint).)
Study intervention:
Patients wear the Swibrace 3D splint for 6 weeks of immobilization of the wrist for distal radius fractures, including the basis of the thumb for scaphoid fractures. X-rays after week 1, 3 and 6 are planned to document bone healing, together with weekly visits at the hand therapy unit to measure patient satisfaction and hand function. This results in 2-3 surgeon and 6 hand therapy visits at the Inselspital Bern, where regular check-ups on the patient's comfort in the splint are made.
The control intervention is the same as the study intervention, but the participants wear the "gold-standard" plaster cast instead of the newly designed Swibrace 3D-splint. For the pre-clinical study, there is no control intervention.
(Healthy volunteers wear the Swibrace 3D splint for 72 hours. During this time, they are allowed to use their splinted hand for their usual daily activities, except for driving a car. They note their activities in a diary. At the end of the splint wearing time, they complete the ARSEQ. The scanning procedure will take at a place convenient for the volunteers.)
Study objectives:
The primary objective of this study is to assess if the patients' personal experiences and perceptions of safety and satisfaction (as defined by the self-designed "Patient rated splint evaluation questionnaire" (PRSEQ)) are superior in the Swibrace PSAB compared to a custom-made plaster cast.
Secondary objectives are:
To examine if there is a significant difference in self-perceived hand function and pain between the two groups (as assessed by the self-designed "Patient rated splint evaluation questionnaire" (PRSEQ)) To assess if radiological parameters between groups are similar at the end of the splint wearing period.
(To evaluate satisfaction with the 3D splint in healthy volunteers before testing the 3D splint in patients.)
The safety objectives are:
To document the attrition rate and - if applicable - reasons for drop-out in the Swibrace PSAB group (drop-out means that the participants make a cross-over to the control group until bone healing is assured) during the splint wearing time.
The X-ray appointments at Inselspital Bern, checking for the bone's correct healing position
The patients' safety perception (as assessed by the self-designed PRSEQ)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization is based on a single allocation ratio of 1:1 In order to generate an unpredictable allocation sequence and concealment of that sequence until assignment occurs, sequentially numbered, sealed, opaque envelopes will be prepared.
| Arm | Type | Receives |
|---|---|---|
| 3D-splint group | Experimental | Device: Swibrace 3D-splintPatients wear the Swibrace 3D splint for 6 weeks of immobilization of the wrist for distal radius fractures, including the basis of the thumb for scaphoid fractures. X-rays after week 1, 3 and 6 are planned to document bone healing, together with weekly visits at the hand therapy unit to measure patient satisfaction and hand function. This results in 2-3 surgeon and 6 hand therapy visits at the Inselspital Bern, where regular check-ups on the patient's comfort in the splint are made. |
| Plaster cast group | Active comparator | Device: Plaster castThe control intervention is the same as the study intervention, but the participants wear the "gold-standard" plaster cast instead of the newly designed Swibrace 3D-splint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent as documented by signature
- ≥ 18 years old
- Understanding of German language (written and oral)
- Showing up at the Inselspital Bern emergency department with a stable, nondisplaced distal radius or scaphoid fracture that classifies a conservative immobilization treatment (as decided by the present surgeon on duty)
Key exclusion criteria (4 listed)
- Known or suspected non-compliance
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- < 18 years old
- Vulnerable persons
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 |
|---|---|---|
| Swibrace 3D-splintThe Swibrace 3D splint is a custom-made splint. For scanning of the forearms, the investigators will use the scanner "HandySCAN300" and the therewith delivered software "VXElements", the latter being necessary to create an accurate scan on the computer. Printing of the splint will be done by "Materialise", Belgium. | Device | 3D-splint group |
| Plaster castThe conservative gold standard treatment of distal radius and scaphoid fractures is applying a plaster cast. Therefore, patients in the control group follow standard therapy procedures. | Device | Plaster cast group |
Primary outcome
Change in "Patient Reported Splint Evaluation Questionnaire (PRSEQ)"
Time frame: Part 1 will be filled out during (at week 2, 4, 6) and Part 2 after the splint wearing time (week 6).
The investigators designed this questionnaire to the best of their knowledge due to lack of pre-existing orthosis satisfaction questionnaires suitable for the study purposes. The PRSEQ will be completed by the participating patients. It consists of two parts: Part 1 consist of 5 main topics: (1) pain because of the splint, (2) personal experiences with the splint, (3) personal safety, (4) specific and (5) usual activities in the splint. Pictures from the splint are given to allow ticking pressure marks and skin irritations where they appeared. Part 2 consists of 3 main topics: (6) satisfaction with the splint, (7) personal attitude and (8) satisfaction with the scanning procedure. Each main topic includes several sub-questions, where the patient rates his/her answers on a 11-point-Likert scale (0-10).
7 secondary outcomes
Hand therapy evaluation - applying the "assessment of patient satisfaction"
Time frame: Assessed during 6 hand therapy visits on a weekly basis until week 6, starting in week 1
Hand therapy evaluation - finger range of motion as assessed by a hand-held goniometer
Time frame: Assessed during 6 hand therapy visits on a weekly basis until week 6, starting in week 1
Hand therapy evaluation - sensibility as measured by the "Ten Test"
Time frame: Assessed during 6 hand therapy visits on a weekly basis until week 6, starting in week 1
Hand therapy evaluation - pain as measured by the "Numeric Rating Scale"
Time frame: Assessed during 6 hand therapy visits on a weekly basis until week 6, starting in week 1
Bone position - x-ray evaluation by specialized hand surgeons and orthopedists
Time frame: 2-3 regular x-rays will take place during the bone healing phase after 1 week of splint wearing, if necessary in week 2 and after 6 weeks as assessed by physicians
Questionnaire "assessment of clinical effectiveness" as rated by specialized hand surgeons and orthopedists
Time frame: Administered once at the end of the study after 6 weeks
Composite endpoint "adherence" assessed as the "number of clinical visits that were missed" / "number of drop-outs" and "number of patients crossing over to the plaster cast group"
Time frame: Ongoing during the whole study period of 6 weeks
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 30 Nov 2023.
- Study description at Inselspital Bern, SwitzerlandLink provided by the sponsor.
- collaboration partner, 3D-technology, Fribourg, SwitzerlandLink provided by the sponsor.
- 3D printing company, BelgiumLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Esther Vögelin, Prof study director
Department of Plastic and Hand Surgery (DOPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swibrace 3D-splint and Plaster cast in people with Distal Radius Fracture and Scaphoid Fracture, run by Insel Gruppe AG, University Hospital Bern 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 4 inclusion and 4 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 30 Nov 2023. 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 Reported Splint Evaluation Questionnaire (PRSEQ)" (time frame: Part 1 will be filled out during (at week 2, 4, 6) and Part 2 after the splint wearing time (week 6).). 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 30 Nov 2023.