Hip FractureNCT02133794
Tomosynthesis Use in Detecting Subtle Occult Hip Fractures
A study testing Tomosynthesis in people with Hip Fracture, run by Medical Imaging Informatics Research Centre at McMaster at 1 site in Canada.
Trial summary
The purpose of this project is to determine if using tomosynthesis, in conjunction with x-ray, is better at detecting hip fractures than using x-ray alone. The goal of this study will be to include the use of tomosynthesis with x-ray as usual practice when a patient comes to the emergency room with symptoms of a hip… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Tomosynthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- Men and women aged > 18 years who/se:
- Present at the ER with a possible hip fracture and
- Have a negative x-ray for a hip fracture
- Physician has a high clinical suspicion of a hip fracture
- Provide provision of informed consent
Who cannot join
- Hip prosthesis on the same side of the suspected hip fracture
- Other serious medical illness that is likely to interfere with study participation
- Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the trial procedures
- Pregnant or suspected pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this project is to determine if using tomosynthesis, in conjunction with x-ray, is better at detecting hip fractures than using x-ray alone. The goal of this study will be to include the use of tomosynthesis with x-ray as usual practice when a patient comes to the emergency room with symptoms of a hip fracture.
- Conditions
- Hip Fracture
- Being tested
- Tomosynthesis
- Keywords
- Hip fracture, Tomosynthesis, X-ray, Emergency room
- Medical subject headings
- Hip Fractures, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TomosynthesisDevice
Also called GE Discovery 650
| Study group | Role | What they receive |
|---|---|---|
| Tomosynthesis | Experimental | Not described Receives: Device: Tomosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with hip fracture detected with tomosynthesis versus x-ray alone.
Measured: Participants will be followed up to 3 months post tomosynthesis exam.
Secondary outcomes (1)
ER wait time
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Imaging Informatics Research Centre at McMaster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naveen Parasu, Medical Imaging Informatics Research Centre at McMaster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133794
- Sponsor's protocol ID
- Parasu-001
- Status last verified
- Apr 2014
- First submitted
- 23 Apr 2014
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tomosynthesis Use in Detecting Subtle Occult Hip Fractures
- ClinicalTrials.gov ID
- NCT02133794
- Acronym / sponsor ID
- Parasu-001
- Conditions
- Hip Fracture
- Keywords
- Hip fracture, Tomosynthesis, X-ray, Emergency room
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical Imaging Informatics Research Centre at McMasterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 8 May 2014 (estimated)
- 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.
The purpose of this project is to determine if using tomosynthesis, in conjunction with x-ray, is better at detecting hip fractures than using x-ray alone. The goal of this study will be to include the use of tomosynthesis with x-ray as usual practice when a patient comes to the emergency room with symptoms of a hip fracture.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tomosynthesis | Experimental | Device: Tomosynthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged > 18 years who/se:
- Present at the ER with a possible hip fracture and
- Have a negative x-ray for a hip fracture
- Physician has a high clinical suspicion of a hip fracture
- Provide provision of informed consent
Key exclusion criteria (4 listed)
- Hip prosthesis on the same side of the suspected hip fracture
- Other serious medical illness that is likely to interfere with study participation
- Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the trial procedures
- Pregnant or suspected pregnancy
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 |
|---|---|---|
| TomosynthesisAlso: GE Discovery 650 | Device | Tomosynthesis |
Primary outcome
Number of patients with hip fracture detected with tomosynthesis versus x-ray alone.
Time frame: Participants will be followed up to 3 months post tomosynthesis exam.
1 secondary outcome
ER wait time
Time frame: End of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tomosynthesis in people with Hip Fracture, run by Medical Imaging Informatics Research Centre at McMaster at 1 site 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with hip fracture detected with tomosynthesis versus x-ray alone. (time frame: Participants will be followed up to 3 months post tomosynthesis exam.). 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 8 May 2014; AzTrials last refreshed its copy on 3 Nov 2026.