Trauma (Including Fractures)Phase 3NCT07580976
Tru-Vu Wrist Positioning Aid Multi-Center Implementation Within NLHS
A Phase 3 study testing Tru Vu tool and training in people with Trauma (Including Fractures) and Arthritis, run by Western University at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma (Including Fractures), Arthritis
- What is being tested?
- Tru Vu tool and training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 3 sitesCanada
- Study dates
- 14 Jun 2026to 1 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Incapable of providing informed consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites
Labrador Health Centre
Happy Valley-Goose Bay, Labrador, A0P1C0
Emily Lalone, PhD, 519-661-2111 ext. 88243, emily.lalone@uwo.ca
Bonne Bay Health Centre
Norris Point, Newfoundland and Labrador, A8A3L1
Emily Lalone, PhD, 519-661-2111 ext. 88243, emily.lalone@uwo.ca
Health Sciences Centre
St. John's, Newfoundland and Labrador, A1B3V6
Emily Lalone, PhD, 519-661-2111 ext. 88243, emily.lalone@uwo.ca
About this study
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:
- Will the implementation of the Tru-Vu differ between an urban health center, rural clinic, and remote regional hospital?
- Can the Tru-Vu improve the positioning procedure for radiographers performing wrist x-rays, resulting with more useful x-rays.
Read more
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.
- Conditions
- Trauma (Including Fractures), Arthritis
- Being tested
- Tru Vu tool and training
- Medical subject headings
- Wounds and Injuries, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tru Vu tool and trainingDevice
A positioning aid and training videos for wrist x-rays
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Tru Vu tool and training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiograph grading score
Radiographs collected retrospectively and prospectively will be graded by a radiologist and radiographer
Measured: 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).
Measured: The survey will be administered 6 months after the implementation of the tool and training.
Secondary outcomes (2)
Sustainability
Post-follow up survey will be conducted 6 months after the end of the implementation period and will collect perceived tool use.
Measured: 6 months after the conclusion of the implementation period
Repeated radiographs
Document the number of repeat radiographs captured.
Measured: Repeat radiographs will be collected and compared 4 months retrospectively prior to implementation and 6 months after the start of implementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start14 Jun 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma (Including Fractures)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University
- Sponsor type
- University, hospital or other
- Collaborators
- Newfoundland Health Services, NLHS
- Responsible party
- Principal investigator, Emily Lalone, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580976
- Sponsor's protocol ID
- 129141
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tru-Vu Wrist Positioning Aid Multi-Center Implementation Within NLHS
- ClinicalTrials.gov ID
- NCT07580976
- Acronym / sponsor ID
- 129141
- Conditions
- Trauma (Including Fractures), Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Western UniversityUniversity, hospital or other
- Collaborators
- Newfoundland Health Services, NLHS
- Study start
- 14 Jun 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Will the implementation of the Tru-Vu differ between an urban health center, rural clinic, and remote regional hospital?
- 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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Urban hospital | Experimental | Device: Tru Vu tool and trainingRadiographs 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. |
| Rural health center | Experimental | Device: Tru Vu tool and trainingRadiographs 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. |
| Regional remote hospital | Experimental | Device: Tru Vu tool and trainingRadiographs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Incapable of providing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tru Vu tool and trainingA positioning aid and training videos for wrist x-rays | Device | Regional remote hospital, Rural health center, Urban hospital |
Primary outcome
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
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).
2 secondary outcomes
Sustainability
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tru Vu tool and training in people with Trauma (Including Fractures) and Arthritis, run by Western University at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Lalone, PhD (519-661-2111 ext. 88243, emily.lalone@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.