AR US Versus sUS or Fluoroscopic Injections for Shoulder Punction
September 1, 2025 updated by: Balgrist University Hospital
Comparison of Time for Prucedure, and Effectiveness Between Augmented Reality Enhanced Ultrasound-guided Versus Standard Ultrasound or Fluoroscopic Injections
The goal of this clinical trial is to prospectively evaluate the potential benefits of injections with Augmented Reality enhanced Ulrasound versus standard Ultrasound or fluoroscopy participants where assigend for fluoroscopic joint injections oder for Ultrasound guided injection.
The main question[s] it aims to answer are:
- The primary objective is to evaluate the duration of the different interventions
- the count of needle passes
- assess the reduction of radiation exposure using AR US rather than fluoroscopic guidance for joint injections
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Patients assigned for standard Ultrasound or fluoroscopic joint injection are informed about the trial. Participants are randomly assigned to the study or control intervention. 1:1 randomization is used.
In both groups, data on duration of the intervention, count of needle passes, correctness of injection location and radiation exposure will be collected. The outcome measures will be compared between the groups.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zurich, Switzerland, 8008
- University Hospital Zurich
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- - Patients 18 to 99 years of age
- Patients assigned for fluoroscopic guided injections (including MR arthrographies)
- Patients assigned for US guided injections (including MR arthrographies)
Exclusion Criteria:
- - Patients who are not willing to be part of the study
- Contraindication against fluoroscopic guided injection
- Women who are pregnant or breast feeding (Pregnancy assessment is part of the routine prior to fluoroscopic joint injections. No pregnancy test will be done for this study.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: AR US
Augmented reality sonography guidance for shoulder punctures
|
Shoulder puncture with the newly designed technique using AR to overlie the US image to the imaged anatomical structures in comparision to standard US and flurosopic-guidance.
|
|
Active Comparator: standard US
standard sonography guidance for shoulder punctures
|
Shoulder puncture with the newly designed technique using AR to overlie the US image to the imaged anatomical structures in comparision to standard US and flurosopic-guidance.
|
|
Active Comparator: Fluoroscopic
Fluroscopic guidance for shoulder punctures
|
Shoulder puncture with the newly designed technique using AR to overlie the US image to the imaged anatomical structures in comparision to standard US and flurosopic-guidance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Augmented reality sonography is less time consuming
Time Frame: 10 minutes
|
Puncturing shoulders with Augmented reality sonography is faster (measuring the time in minutes and seconds) than when using standard sonography- from point of entry the skin until the target
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sonography is more efficient than fluoroscopic- guidance in shoulder puncturing
Time Frame: 10 minutes (ml aspirated) to 3 days (laboratory results)
|
More fluid (measured in ml) can be aspirated with lower false negative results (laboratory results) when puncutring shoulders with US-guidance in comparison to fluoroscopic guidance
|
10 minutes (ml aspirated) to 3 days (laboratory results)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 13, 2023
Primary Completion (Actual)
January 31, 2025
Study Completion (Actual)
January 31, 2025
Study Registration Dates
First Submitted
May 15, 2023
First Submitted That Met QC Criteria
September 22, 2023
First Posted (Actual)
September 26, 2023
Study Record Updates
Last Update Posted (Estimated)
September 8, 2025
Last Update Submitted That Met QC Criteria
September 1, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- R471
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.