Distal Radius FracturesNCT06062797
Improving Patient Understanding in Preoperative Informed Consent Process of Trauma Patients Using a Mixed Reality Viewer
A study testing Mixed Reality Viewer and X-ray or CT scan in people with Distal Radius Fractures and Ankle Fractures, run by LMU Klinikum at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Distal Radius Fractures, Ankle Fractures, Proximal Humeral Fracture
- What is being tested?
- Mixed Reality Viewer and X-ray or CT scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 18 Apr 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for surgery of a distal radius fracture, upper ankle fracture, or proximal humerus fracture using plate osteosynthesis
- Age ≥ 18 years old
- Existing signed confirmation of participation in the study
- Ability to understand a German interview and questionnaire
Who cannot join
- Epilepsy
- Patients with mental limitations (e.g. dementia) or severe visual impairments that prevent informed consent emergency surgery
- Age < 18 or > 80 years old
- Inability to understand a German interview and questionnaire
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Orthopaedics and Trauma Surgery, Musculoskeletal University Center Munich (MUM), University Hospital, LMU Munich
Munich, Bavaria, 81377
Rouven Neudeck, +49 (0)894400-83203, r.neudeck@med.uni-muenchen.de
About this study
Official title: Improving Patient Understanding in the Preoperative Informed Consent Process of Trauma Patients Using a Mixed Reality Viewer
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:
Read more
- 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.
Read the detailed description
In everyday clinical practice, patients receive a verbal explanation of their medical condition, optional treatment options, and information about the benefits, risks and complications of surgery during preoperative education. To visualize the respective fractures to the patients, they are shown using X-rays, CT scans or MRI images. However, these images are often difficult to understand without prior medical knowledge.
A better understanding of the fracture by the patients and a more comprehensible visualization of the operations can lead to better informed consent between the patients and the doctor. Consequential benefits for treatment and postoperative follow-up may follow.
The investigators hypothesis is that fracture visualization using a Mixed Reality Viewer can generate higher fracture understanding in patients. As a result of better education, this visualization method could lead to higher patient satisfaction and anxiety reduction.
Patients with an indication for surgery of a distal radius fracture, upper ankle fracture or proximal humerus fracture using plate osteosynthesis are randomized into the intervention group or the control group. Both study groups watch verbal education via a recorded video. The intervention group afterward receives a fracture visualization via mixed reality glasses. The control group receives fracture visualization via X-ray or CT scan.
In both the intervention group and the control group, the type of fracture, the extent of the fracture, the surgical method, and the benefits and risks of the surgery are explained to the patients during the visualization.
After the explanation is completed, patients are asked to complete a questionnaire regarding satisfaction and fracture understanding.
- Being tested
- Mixed Reality Viewer, X-ray or CT scan
- Keywords
- Distal Radius Fracture, Proximal Humeral Fracture, Ankle Fracture, Mixed Reality, Patient Education, Informed Consent, Patient Satisfaction
- Medical subject headings
- Wrist Fractures, Ankle Fractures, Shoulder Fractures, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed Reality ViewerDevice
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.
X-ray or CT scanDevice
X-ray or CT scan enables the visualization of the fracture in 2D.
| Study group | Role | What they receive |
|---|---|---|
| Mixed Reality | Experimental | Fracture visualization via Mixed Reality Viewer Receives: Device: Mixed Reality Viewer |
| X-ray or CT scan | Active comparator | Fracture visualization via X-ray or CT scan Receives: Device: X-ray or CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Understanding
A questionnaire is used to determine the patients' level of understanding via content-related questions about their specific fractures. Patients answer questions on a 6-point Likert scale, with higher scores indicating better outcome.
Measured: Measurement is assessed via a questionnaire immediately after the procedure.
Patient Satisfaction with the educational process assessed by the 6-point Likert scale
A questionnaire is used to determine the patient's satisfaction with the educational process. Patients answer questions on a 6-point Likert scale, with higher scores indicating better outcome.
Measured: Measurement is assessed via a questionnaire immediately after the procedure.
Patient Preoperative Anxiety
A questionnaire is used to determine the patient's anxiety regarding their upcoming surgical procedure. Patients answer the question on a 10-point Likert scale, with higher scores indicating worse outcome..
Measured: Measurement is assessed via a questionnaire immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start18 Apr 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantin Wehrkamp, LMU Klinikum
- Investigators
- Fabian Gilbert, PD Dr. med, Study director, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062797
- Sponsor's protocol ID
- 22-0936
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient Understanding in the Preoperative Informed Consent Process of Trauma Patients Using a Mixed Reality Viewer
- ClinicalTrials.gov ID
- NCT06062797
- Acronym / sponsor ID
- 22-0936
- Keywords
- Distal Radius Fracture, Proximal Humeral Fracture, Ankle Fracture, Mixed Reality, Patient Education, Informed Consent, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In everyday clinical practice, patients receive a verbal explanation of their medical condition, optional treatment options, and information about the benefits, risks and complications of surgery during preoperative education. To visualize the respective fractures to the patients, they are shown using X-rays, CT scans or MRI images. However, these images are often difficult to understand without prior medical knowledge.
A better understanding of the fracture by the patients and a more comprehensible visualization of the operations can lead to better informed consent between the patients and the doctor. Consequential benefits for treatment and postoperative follow-up may follow.
The investigators hypothesis is that fracture visualization using a Mixed Reality Viewer can generate higher fracture understanding in patients. As a result of better education, this visualization method could lead to higher patient satisfaction and anxiety reduction.
Patients with an indication for surgery of a distal radius fracture, upper ankle fracture or proximal humerus fracture using plate osteosynthesis are randomized into the intervention group or the control group. Both study groups watch verbal education via a recorded video. The intervention group afterward receives a fracture visualization via mixed reality glasses. The control group receives fracture visualization via X-ray or CT scan.
In both the intervention group and the control group, the type of fracture, the extent of the fracture, the surgical method, and the benefits and risks of the surgery are explained to the patients during the visualization.
After the explanation is completed, patients are asked to complete a questionnaire regarding satisfaction and fracture understanding.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mixed Reality | Experimental | Device: Mixed Reality ViewerFracture visualization via Mixed Reality Viewer |
| X-ray or CT scan | Active comparator | Device: X-ray or CT scanFracture visualization via X-ray or CT scan |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Indication for surgery of a distal radius fracture, upper ankle fracture, or proximal humerus fracture using plate osteosynthesis
- Age ≥ 18 years old
- Existing signed confirmation of participation in the study
- Ability to understand a German interview and questionnaire
Key exclusion criteria (4 listed)
- Epilepsy
- Patients with mental limitations (e.g. dementia) or severe visual impairments that prevent informed consent emergency surgery
- Age < 18 or > 80 years old
- Inability to understand a German interview and questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed Reality ViewerThe 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 | Mixed Reality |
| X-ray or CT scanX-ray or CT scan enables the visualization of the fracture in 2D. | Device | X-ray or CT scan |
Primary outcome
Patient Understanding
Time frame: Measurement is assessed via a questionnaire immediately after the procedure.
A questionnaire is used to determine the patients' level of understanding via content-related questions about their specific fractures. Patients answer questions on a 6-point Likert scale, with higher scores indicating better outcome.
Patient Satisfaction with the educational process assessed by the 6-point Likert scale
Time frame: Measurement is assessed via a questionnaire immediately after the procedure.
A questionnaire is used to determine the patient's satisfaction with the educational process. Patients answer questions on a 6-point Likert scale, with higher scores indicating better outcome.
Patient Preoperative Anxiety
Time frame: Measurement is assessed via a questionnaire immediately after the procedure.
A questionnaire is used to determine the patient's anxiety regarding their upcoming surgical procedure. Patients answer the question on a 10-point Likert scale, with higher scores indicating worse outcome..
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabian Gilbert, PD Dr. med study director
LMU Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed Reality Viewer and X-ray or CT scan in people with Distal Radius Fractures and Ankle Fractures, run by LMU Klinikum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rouven Neudeck (+49 (0)894400-83203, r.neudeck@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Understanding (time frame: Measurement is assessed via a questionnaire immediately after the procedure.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.