AR US Versus sUS or Fluoroscopic Injections for Shoulder Punction

Not Applicable

Not yet recruiting

• Conditions: Interventions; Ultrasound
• Interventions: Diagnostic Test: Puncture

• Registration Number: NCT06053892
• Lead Sponsor: Balgrist University Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-05-15
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-22
• Last Update Submitted: 2023-09-22
• Study First Posted: 2023-09-26
• Last Update Posted: 2023-09-26
• Study Start: 2023-09-30
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoroscopic	Puncture	Fluroscopic guidance for shoulder punctures
AR US	Puncture	Augmented reality sonography guidance for shoulder punctures
standard US	Puncture	standard sonography guidance for shoulder punctures

Primary Outcome Measures

Name	Time	Method
Augmented reality sonography is less time consuming	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

Secondary Outcome Measures

Name	Time	Method
Sonography is more efficient than fluoroscopic- guidance in shoulder puncturing	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