AR US Versus sUS or Fluoroscopic Injections for Shoulder Punction

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Comparison of Time for Prucedure, and Effectiveness Between Augmented Reality Enhanced Ultrasound-guided Versus Standard Ultrasound or Fluoroscopic Injections

Conditions
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Ultrasound, Interventions

Intervention / Treatment
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* Diagnostic Test: Puncture


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AR US<br>Augmented reality sonography guidance for shoulder punctures | Diagnostic Test: Puncture<br>* 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.<br>|
| Active Comparator: standard US<br>standard sonography guidance for shoulder punctures | Diagnostic Test: Puncture<br>* 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.<br>|
| Active Comparator: Fluoroscopic<br>Fluroscopic guidance for shoulder punctures | Diagnostic Test: Puncture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Augmented reality sonography is less time consuming | 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 | 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) |