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Acceptability and Safety of 3D Printed Wrist-based Splints

NCT05075135 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-11-30

No results posted yet for this study

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

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Esther Vögelin, Prof · Department of Plastic and Hand Surgery (DOPH)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-09
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05075135 on ClinicalTrials.gov