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Difficulties in recruiting and implementing the study design due to missing ressources.
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR US | Active Comparator | Augmented reality sonography guidance for shoulder punctures |
|
| standard US | Active Comparator | standard sonography guidance for shoulder punctures |
|
| Fluoroscopic | Active Comparator | Fluroscopic guidance for shoulder punctures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Puncture | Diagnostic Test | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Zurich | 8008 | Switzerland |
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The assignment into the study groups is going to be performed by 1:1 randomization using randomisation cards which are drawn by author-ised study staff.
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