Acceptability and Safety of 3D Printed Wrist-based Splints

Study Overview
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Brief Summary
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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
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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)

Official Title
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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.

Conditions
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Distal Radius Fracture, Scaphoid Fracture

Intervention / Treatment
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* Device: Swibrace 3D-splint
* Device: Plaster cast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D-splint group<br>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. | Device: Swibrace 3D-splint<br>* 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.<br>|
| Active Comparator: Plaster cast group<br>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. | Device: Plaster cast<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Part 1 will be filled out during (at week 2, 4, 6) and Part 2 after the splint wearing time (week 6). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). | 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. | 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 | 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. | 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. | Ongoing during the whole study period of 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D-splinting, Plaster cast, Patient satisfaction, Distal radius fracture, Scaphoid fracture