Hip FracturesNCT01984385
Hip Fracture Impact on Vascular Events In Noncardiac Surgery patIents: a cOhort evaluatioN (Hip VISION): Pilot Study
An observational study of Hip Fractures, run by Population Health Research Institute at 1 site in Canada.
Trial summary
Hip VISION (Pilot Study) is a Prospective Observational Cohort Study to evaluate the incidence of overall and cause-specific mortality among consecutive patients aged ≥ 18 years presenting with hip fracture to the Juravinski Hospital of the Hamilton Health Sciences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Oct 2015
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hip fracture
Who may be able to join
- Patients aged ≥ 18 years with hip fractures (i.e. fractures involving the subcapital, femoral neck, or intertrochanteric regions), treated either operatively or non-operatively
- Mechanism of injury consistent with either:
- A fall from a standing height or;
- Another mechanism of injury which, in the clinical judgment of an orthopedic surgeon, would impart the same or less traumatic energy as a fall from a standing height
Who cannot join
- Patients with fractures isolated to the proximal femoral shaft, with no involvement of the intertrochanteric, femoral neck, or subcapital region
- Patients with hip fractures resulting from high energy mechanisms, such as motor vehicle accidents or falls from a substantial height
- Patient who refuse 30-day or 6-month follow up
- Patients who refuse to consent either by themselves or through a substitute decision-maker (for patients unable to consent, we will use a deferred consent process, as described below).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Juravinski Hospital and Cancer Centre (HHS)
Hamilton, Ontario, L8V 5C2
About this study
Hip VISION (Pilot Study) is a Prospective Observational Cohort Study to evaluate the incidence of overall and cause-specific mortality among consecutive patients aged ≥ 18 years presenting with hip fracture to the Juravinski Hospital of the Hamilton Health Sciences. This pilot study will assess the feasibility of a larger prospective international cohort study. After eligibility has been confirmed and informed consent has been obtained, participants will be registered in the study. Troponin level, complete blood counts and serum creatinine level will be collected at day 1 through day 10 post admission. CAM instrument will be employed at admission and once daily post admission day 1 through day 10. FIM Instrument will be administered within 72 hours of admission to establish pre-fracture functional independence and disability. Patients will be contacted by research personnel by telephone 30 days after study registration.
- Conditions
- Hip Fractures
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a hip fracture | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total and cause specific mortality in hip fracture patients at 30 days
Measured: 30 days
Major complications within 30 days.
Composite of vascular mortality, nonfatal MI, nonfatal stroke, nonfatal PE, sepsis, and life-threatening bleeding.
Measured: 30 days
Secondary outcomes (21)
Nonfatal myocardial infarction
Measured: 30 days
Nonfatal myocardial injury after noncardiac surgery
Measured: 30 days
Nonfatal pulmonary embolism
Measured: 30 days
Nonfatal infection
Measured: 30 days
Nonfatal bleeding
Measured: 30 days
Nonfatal stroke
Measured: 30 days
New congestive heart failure
Measured: 30 days
New atrial fibrillation
Measured: 30 days
Nonfatal cardiac arrest
Measured: 30 days
Deep vein thrombosis
Measured: 30 days
New acute renal failure requiring dialysis
Measured: 30 days
Cardiac catheterization
Measured: 30 days
PCI
Measured: 30 days
CABG
Measured: 30 days
CAM days 1-7 post-op
Measured: 1-7 days post-op
Implant failure or periprosthetic fracture
Measured: 30 days
Re-operation
Measured: 30 days
Length of hospital stay
Measured: 30 days
New nursing home residence
Measured: 30 days
First mobilization
Measured: 30 days
FIM (motor function)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionSep 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, P.J. Devereaux, Population Health Research Institute
- Investigators
- PJ Devereaux, PhD, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984385
- Sponsor's protocol ID
- HipVISION Pilot - 2013
- Status last verified
- Oct 2015
- First submitted
- 7 Nov 2013
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Fracture Impact on Vascular Events In Noncardiac Surgery patIents: a cOhort evaluatioN (Hip VISION): Pilot Study
- ClinicalTrials.gov ID
- NCT01984385
- Acronym / sponsor ID
- HipVISION Pilot - 2013
- Conditions
- Hip Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 14 Nov 2013 (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.
Hip VISION (Pilot Study) is a Prospective Observational Cohort Study to evaluate the incidence of overall and cause-specific mortality among consecutive patients aged ≥ 18 years presenting with hip fracture to the Juravinski Hospital of the Hamilton Health Sciences. This pilot study will assess the feasibility of a larger prospective international cohort study. After eligibility has been confirmed and informed consent has been obtained, participants will be registered in the study. Troponin level, complete blood counts and serum creatinine level will be collected at day 1 through day 10 post admission. CAM instrument will be employed at admission and once daily post admission day 1 through day 10. FIM Instrument will be administered within 72 hours of admission to establish pre-fracture functional independence and disability. Patients will be contacted by research personnel by telephone 30 days after study registration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a hip fracture | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hip fracture
Key inclusion criteria (4 listed)
- Patients aged ≥ 18 years with hip fractures (i.e. fractures involving the subcapital, femoral neck, or intertrochanteric regions), treated either operatively or non-operatively
- Mechanism of injury consistent with either:
Key exclusion criteria (4 listed)
- Patients with fractures isolated to the proximal femoral shaft, with no involvement of the intertrochanteric, femoral neck, or subcapital region
- Patients with hip fractures resulting from high energy mechanisms, such as motor vehicle accidents or falls from a substantial height
- Patient who refuse 30-day or 6-month follow up
- Patients who refuse to consent either by themselves or through a substitute decision-maker (for patients unable to consent, we will use a deferred consent process, as described below).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total and cause specific mortality in hip fracture patients at 30 days
Time frame: 30 days
Major complications within 30 days.
Time frame: 30 days
Composite of vascular mortality, nonfatal MI, nonfatal stroke, nonfatal PE, sepsis, and life-threatening bleeding.
21 secondary outcomes
Nonfatal myocardial infarction
Time frame: 30 days
Nonfatal myocardial injury after noncardiac surgery
Time frame: 30 days
Nonfatal pulmonary embolism
Time frame: 30 days
Nonfatal infection
Time frame: 30 days
Nonfatal bleeding
Time frame: 30 days
Nonfatal stroke
Time frame: 30 days
New congestive heart failure
Time frame: 30 days
New atrial fibrillation
Time frame: 30 days
Nonfatal cardiac arrest
Time frame: 30 days
Deep vein thrombosis
Time frame: 30 days
New acute renal failure requiring dialysis
Time frame: 30 days
Cardiac catheterization
Time frame: 30 days
PCI
Time frame: 30 days
CABG
Time frame: 30 days
CAM days 1-7 post-op
Time frame: 1-7 days post-op
Implant failure or periprosthetic fracture
Time frame: 30 days
Re-operation
Time frame: 30 days
Length of hospital stay
Time frame: 30 days
New nursing home residence
Time frame: 30 days
First mobilization
Time frame: 30 days
FIM (motor function)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
Related trials for Hip Fractures
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
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.
PJ Devereaux, PhD principal investigator
Population Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures, run by Population Health Research Institute 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 4 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: finished, as of the sponsor's last update on 6 Oct 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total and cause specific mortality in hip fracture patients at 30 days (time frame: 30 days). 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 6 Oct 2015.