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Improving Patient Understanding in Preoperative Informed Consent Process of Trauma Patients Using a Mixed Reality Viewer

NCT06062797 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-10-02

No results posted yet for this study

Summary

This clinical trial aims to compare a Mixed Reality Viewer in the preoperative informed consent process to standard fracture visualization. The participants population are patients with an indication for surgery of a distal radius fracture, upper ankle fracture or proximal humerus fracture using plate osteosynthesis.

The main questions aim to answer are:

* Does the use of the Mixed Reality Viewer improve patient understanding?
* Does the use of the Mixed Reality Viewer improve patient satisfaction?
* Does the use of the Mixed Reality Viewer reduce patient preoperative anxiety?

Participants will have their fracture presented via the Mixed Reality Viewer. Researchers will compare standard fracture imaging using X-ray or CT scans to see if there is any difference in understanding, satisfaction and anxiety.

Conditions

  • Distal Radius Fractures
  • Ankle Fractures
  • Proximal Humeral Fracture

Interventions

DEVICE

Mixed Reality Viewer

The Mixed Reality Viewer from Brainlab (Germany) enables the visualization of the fracture via a 3D hologram. In contrast to virtual reality, where the user is in a completely virtual world, the user of the mixed reality viewer sees the 3D hologram implemented in his real environment.

DEVICE

X-ray or CT scan

X-ray or CT scan enables the visualization of the fracture in 2D.

Sponsors & Collaborators

  • LMU Klinikum

    lead OTHER

Principal Investigators

  • Fabian Gilbert, PD Dr. med · LMU Munich

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-18
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • Germany

Study Locations

More Related Trials

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 NCT06062797 on ClinicalTrials.gov