AR US Versus sUS or Fluoroscopic Injections for Shoulder Punction

Balgrist University Hospital

Status: Terminated

Conditions: Interventions; Ultrasound

Treatments: Diagnostic Test: Puncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06053892

R471

Details and patient eligibility

About

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

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 3 patient groups

AR US

Active Comparator group

Description:

Augmented reality sonography guidance for shoulder punctures

Treatment:

Diagnostic Test: Puncture

standard US

Active Comparator group

Description:

standard sonography guidance for shoulder punctures

Treatment:

Diagnostic Test: Puncture

Fluoroscopic

Active Comparator group

Description:

Fluroscopic guidance for shoulder punctures

Treatment:

Diagnostic Test: Puncture