Clinical trial NCT05075135: Acceptability and Safety of 3D Printed Wrist-based Splints
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Scaphoid Fracture
Keywords: 3D-splinting
Plaster cast
Patient satisfaction
Distal radius fracture
Scaphoid fracture
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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. 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)

Eligibility criteria: 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

Primary outcomes:
measure: Change in "Patient Reported Splint Evaluation Questionnaire (PRSEQ)"
timeFrame: Part 1 will be filled out during (at week 2, 4, 6) and Part 2 after the splint wearing time (week 6).
Secondary outcomes:
measure: Hand therapy evaluation - applying the "assessment of patient satisfaction"
timeFrame: Assessed during 6 hand therapy visits on a weekly basis until week 6, starting in week 1
measure: Hand therapy evaluation - finger range of motion as assessed by a hand-held goniometer
timeFrame: Assessed during 6 hand therapy visits on a weekly basis until week 6, starting in week 1
measure: Hand therapy evaluation - sensibility as measured by the "Ten Test"
timeFrame: Assessed during 6 hand therapy visits on a weekly basis until week 6, starting in week 1
measure: Hand therapy evaluation - pain as measured by the "Numeric Rating Scale"
timeFrame: Assessed during 6 hand therapy visits on a weekly basis until week 6, starting in week 1
measure: Bone position - x-ray evaluation by specialized hand surgeons and orthopedists
timeFrame: 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
measure: Questionnaire "assessment of clinical effectiveness" as rated by specialized hand surgeons and orthopedists
timeFrame: Administered once at the end of the study after 6 weeks
measure: 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"
timeFrame: Ongoing during the whole study period of 6 weeks
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital Bern, Hand therapy research unit
Study officials:
affiliation: Department of Plastic and Hand Surgery (DOPH)
name: Esther Vögelin, Prof
role: STUDY_DIRECTOR
References: