Tru-Vu Tool for Wrist Fracture X-Rays

Not yet recruiting at 2 trial locations
EL
Overseen ByEmily Lalone, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Western University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study has two primary aims: 1) to determine whether a novel wrist x-ray positioning aid can be implemented within 3 different healthcare centers in Newfoundland and Labrador, and 2) to determine the ability of the tool to improve patient positioning in wrist x-rays. It will also learn about the number of repeat x-rays required with or without the use of the tool and radiographer confidence. The main questions it aims to answer are:

1. Will the implementation of the Tru-Vu differ between an urban health center, rural clinic, and remote regional hospital?

2. Can the Tru-Vu improve the positioning procedure for radiographers performing wrist x-rays, resulting with more useful x-rays.

Researchers will compare x-rays before and after the implementation of the tool as well as between centers.

Technologist participants will:

* Use the tool during the positioning procedure for wrist x-rays.

* Provide feedback regarding tool use and perceived implementation barriers and facilitators.

Are You a Good Fit for This Trial?

This trial is for radiology technologists who perform wrist x-rays at three different healthcare centers in Newfoundland and Labrador. Patients with wrist fractures may be involved as part of routine care, but the main participants are the staff using the new positioning tool.

Inclusion Criteria

Must be proficient in English (reading/writing)
Must have been referred for wrist imaging at one of the following healthcare centers: Health Sciences Center (St. John's, NL), Bonne Bay Health Center (Norris Point, NL), or Labrador Health Center (Happy Valley-Goose Bay, NL)
I am 18 years old or older.

Exclusion Criteria

I am not able to give informed consent for my treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the Tru-Vu wrist positioning aid across different healthcare centers

6 months
Multiple visits for implementation and feedback collection

Follow-up

Collection of additional radiographs and feedback on tool use

6 months
Regular visits for radiograph collection and surveys

Post-follow-up

Post-follow up survey to assess sustainability and tool use

6 months after follow-up

What Are the Treatments Tested in This Trial?

Trial Overview

The study tests a new device called the Tru-Vu Wrist Positioning Aid and related training to see if it helps radiographers take better wrist x-rays. The tool's use will be compared before and after its introduction across urban, rural, and remote hospitals.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Urban hospitalExperimental Treatment1 Intervention
Group II: Rural health centerExperimental Treatment1 Intervention
Group III: Regional remote hospitalExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Western University

Lead Sponsor

Trials
31
Recruited
129,000+

Newfoundland Health Services

Collaborator

NLHS

Collaborator