AR US Versus sUS or Fluoroscopic Injections for Shoulder Punction

Ultrasound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06053892
• Other study ID #: R471
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2023
• Source: Balgrist University Hospital
• Contact: Nadja Farshad, MD
• Phone: +41443863320
• Email: nadja.farshad[@]balgrist.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Ultrasound

Intervention

Diagnostic Test:
• Puncture
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)