Acceptability and Safety of 3D Printed Wrist-based Splints

NCT ID: NCT05075135

Last Updated: 2023-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-09
• Study Completion Date: 2023-07-31

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)

Conditions

Distal Radius Fracture; Scaphoid Fracture

Keywords

3D-splinting; Plaster cast; Patient satisfaction; Distal radius fracture; Scaphoid fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

3D-splint group

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.

Group Type: EXPERIMENTAL

Swibrace 3D-splint

Intervention Type: DEVICE

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 cast group

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.

Group Type: ACTIVE_COMPARATOR

Plaster cast

Intervention Type: DEVICE

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.

Interventions

Swibrace 3D-splint

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.

Intervention Type: DEVICE

Plaster cast

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esther Vögelin, Prof

Role: STUDY_DIRECTOR

Department of Plastic and Hand Surgery (DOPH)

Locations

Inselspital Bern, Hand therapy research unit

Bern, , Switzerland

Countries

Switzerland

Related Links

http://servicenow.insel.ch/studien?id=ins_studien_form&table=u_contract_management&sys_id=e8ae7960ec6d741046e96abb57855137

Study description at Inselspital Bern, Switzerland

http://www.swibrace.com/

collaboration partner, 3D-technology, Fribourg, Switzerland

https://www.materialise.com/en/about

3D printing company, Belgium

Other Identifiers

2021-00112

Identifier Type: -

Identifier Source: org_study_id