NCT07580976

Brief Summary

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:

  • Use the tool during the positioning procedure for wrist x-rays.
  • Provide feedback regarding tool use and perceived implementation barriers and facilitators.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for phase_3

Timeline
15mo left

Started Jun 2026

Shorter than P25 for phase_3

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 14, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 5, 2026

Last Update Submit

May 13, 2026

Conditions

ArthritisTrauma (Including Fractures)

Outcome Measures

Primary Outcomes (2)

  • Radiograph grading score

    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)

    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 Outcomes (2)

  • Sustainability

    6 months after the conclusion of the implementation period

  • Repeated radiographs

    Repeat radiographs will be collected and compared 4 months retrospectively prior to implementation and 6 months after the start of implementation.

Study Arms (3)

Urban hospital

EXPERIMENTAL

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

Rural health center

EXPERIMENTAL

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

Regional remote hospital

EXPERIMENTAL

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

Interventions

Tru Vu tool and trainingDEVICE

A positioning aid and training videos for wrist x-rays

Regional remote hospitalRural health centerUrban hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Incapable of providing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Labrador Health Centre

Happy Valley-Goose Bay, Labrador, A0P1C0, Canada

Location

Bonne Bay Health Centre

Norris Point, Newfoundland and Labrador, A8A3L1, Canada

Location

Health Sciences Centre

St. John's, Newfoundland and Labrador, A1B3V6, Canada

Location

MeSH Terms

Conditions

Wounds and InjuriesArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Central Study Contacts

Emily Lalone, PhD

CONTACT

519-661-2111emily.lalone@uwo.ca

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 12, 2026

Study Start (Estimated)

June 14, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)