AR US Versus sUS or Fluoroscopic Injections for Shoulder Punction

Sponsor

Balgrist University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06053892

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ultrasound Interventions	Diagnostic Test: Puncture	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

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.

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Sep 30, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: AR US Augmented reality sonography guidance for shoulder punctures	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.
Active Comparator: standard US standard sonography guidance for shoulder punctures	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.
Active Comparator: Fluoroscopic Fluroscopic guidance for shoulder punctures	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.

Arm

Intervention/Treatment

Active Comparator: AR US

Augmented reality sonography guidance for shoulder punctures

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.

Active Comparator: standard US

standard sonography guidance for shoulder punctures

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.

Active Comparator: Fluoroscopic

Fluroscopic guidance for shoulder punctures

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Balgrist University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Balgrist University Hospital

ClinicalTrials.gov Identifier:

NCT06053892

Other Study ID Numbers:

R471

First Posted:

Sep 26, 2023

Last Update Posted:

Sep 26, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 26, 2023