AR US Versus sUS or Fluoroscopic Injections for Shoulder Punction

NCT ID: NCT06053892

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-13

Study Completion Date

2025-01-31

Brief Summary

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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:

* 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

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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.

Conditions

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Ultrasound Interventions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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.

Study Groups

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AR US

Augmented reality sonography guidance for shoulder punctures

Group Type ACTIVE_COMPARATOR

Puncture

Intervention Type 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.

standard US

standard sonography guidance for shoulder punctures

Group Type ACTIVE_COMPARATOR

Puncture

Intervention Type 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.

Fluoroscopic

Fluroscopic guidance for shoulder punctures

Group Type ACTIVE_COMPARATOR

Puncture

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Balgrist University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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R471

Identifier Type: -

Identifier Source: org_study_id

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