Tru-Vu Wrist Positioning Aid Multi-Center Implementation Within NLHS

May 13, 2026 updated by: Emily Lalone, Western University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Labrador
      • Happy Valley-Goose Bay, Labrador, Canada, A0P1C0
        • Labrador Health Centre
        • Contact:
    • Newfoundland and Labrador
      • Norris Point, Newfoundland and Labrador, Canada, A8A3L1
        • Bonne Bay Health Centre
        • Contact:
      • St. John's, Newfoundland and Labrador, Canada, A1B3V6
        • Health Sciences Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must be 18 years of age or older
  • 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).

Exclusion Criteria:

  • Incapable of providing informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Urban hospital
Radiographs will be retrospectively collected and compared to radiographs captured after the implementation of the tool. Additional radiographs will be collected over a 6-month follow-up period.
Device: Tru Vu tool and training
A positioning aid and training videos for wrist x-rays
Experimental: Rural health center
Radiographs will be retrospectively collected and compared to radiographs captured after the implementation of the tool. Additional radiographs will be collected over a 6-month follow-up period.
Device: Tru Vu tool and training
A positioning aid and training videos for wrist x-rays
Experimental: Regional remote hospital
Radiographs will be retrospectively collected and compared to radiographs captured after the implementation of the tool. Additional radiographs will be collected over a 6-month follow-up period.
Device: Tru Vu tool and training
A positioning aid and training videos for wrist x-rays

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Radiograph grading score
Time Frame: Radiographs will be collected retrospectively 4 months prior to implementation and 6 months prospectively after the implementation of the tool.
Radiographs collected retrospectively and prospectively will be graded by a radiologist and radiographer
Radiographs will be collected retrospectively 4 months prior to implementation and 6 months prospectively after the implementation of the tool.
Tool adoption (and associated implementation outcomes)
Time Frame: The survey will be administered 6 months after the implementation of the tool and training.
A survey will collect perceived tool use and other perceived implementation outcomes (including fidelity, appropriateness, acceptability, and adoption).
The survey will be administered 6 months after the implementation of the tool and training.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sustainability
Time Frame: 6 months after the conclusion of the implementation period
Post-follow up survey will be conducted 6 months after the end of the implementation period and will collect perceived tool use.
6 months after the conclusion of the implementation period
Repeated radiographs
Time Frame: Repeat radiographs will be collected and compared 4 months retrospectively prior to implementation and 6 months after the start of implementation.
Document the number of repeat radiographs captured.
Repeat radiographs will be collected and compared 4 months retrospectively prior to implementation and 6 months after the start of implementation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Western University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Newfoundland Health Services
NLHS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 129141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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