Acceptability and Safety of 3D Printed Wrist-based Splints

NCT05075135 | Completed

• 1 other identifier: 2021-00112
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.)

Conditions

Distal Radius Fracture; Scaphoid Fracture

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Hand therapy evaluation - applying the "assessment of patient satisfaction"

  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

  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"

  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"

  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

  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

Study Arms (2)

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.

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.

Device: Plaster cast

Interventions

Swibrace 3D-splint 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.

3D-splint group

Plaster cast 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.

Plaster cast group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital Bern, Hand therapy research unit

Bern, 3010, Switzerland

Location

Related Links

• Study description at Inselspital Bern, Switzerland
• collaboration partner, 3D-technology, Fribourg, Switzerland
• 3D printing company, Belgium

MeSH Terms

Conditions

Wrist Fractures; Patient Satisfaction

Interventions

Casts, Surgical

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Esther Vögelin, Prof

  Department of Plastic and Hand Surgery (DOPH)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not feasible in this feasibility study, as the participants are not allowed to take off their splint (3D or plaster cast) during the bone healing time of 6 weeks. Care providers will take care of the patients prior to splint removal. Both the patients and the care providers are outcome assessors in this study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 12, 2021
• Study Start: August 9, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)