AR US Versus sUS or Fluoroscopic Injections for Shoulder Punction

NCT06053892 | Terminated DMC

• 1 other identifier: R471
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

Ultrasound; Interventions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sonography is more efficient than fluoroscopic- guidance in shoulder puncturing

  10 minutes (ml aspirated) to 3 days (laboratory results)

Study Arms (3)

AR US

ACTIVE COMPARATOR

Augmented reality sonography guidance for shoulder punctures

Diagnostic Test: Puncture

standard US

ACTIVE COMPARATOR

standard sonography guidance for shoulder punctures

Diagnostic Test: Puncture

Fluoroscopic

ACTIVE COMPARATOR

Fluroscopic guidance for shoulder punctures

Diagnostic Test: Puncture

Interventions

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.

AR US; Fluoroscopic; standard US

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

• \- 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.)

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8008, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: September 26, 2023
• Study Start: June 13, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)