Hip Fracture Impact on Vascular Events In Noncardiac Surgery patIents: a cOhort evaluatioN (Hip VISION): Pilot 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.

Study Overview

• Status: Completed
• Conditions: Hip Fractures

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Hospital and Cancer Centre (HHS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with hip fracture

Description

Inclusion Criteria:

1. Patients aged ≥ 18 years with hip fractures (i.e. fractures involving the subcapital, femoral neck, or intertrochanteric regions), treated either operatively or non-operatively

2. Mechanism of injury consistent with either:

   1. A fall from a standing height or;
   2. 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

Exclusion Criteria:

1. Patients with fractures isolated to the proximal femoral shaft, with no involvement of the intertrochanteric, femoral neck, or subcapital region
2. Patients with hip fractures resulting from high energy mechanisms, such as motor vehicle accidents or falls from a substantial height
3. Patient who refuse 30-day or 6-month follow up
4. 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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with a hip fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total and cause specific mortality in hip fracture patients at 30 days		30 days
Major complications within 30 days.	Composite of vascular mortality, nonfatal MI, nonfatal stroke, nonfatal PE, sepsis, and life-threatening bleeding.	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay	30 days
Nonfatal myocardial infarction	30 days
Nonfatal myocardial injury after noncardiac surgery	30 days
Nonfatal pulmonary embolism	30 days
Nonfatal infection	30 days
Nonfatal bleeding	30 days
Nonfatal stroke	30 days
New congestive heart failure	30 days
New atrial fibrillation	30 days
Nonfatal cardiac arrest	30 days
Deep vein thrombosis	30 days
New acute renal failure requiring dialysis	30 days
Cardiac catheterization	30 days
PCI	30 days
CABG	30 days
CAM days 1-7 post-op	1-7 days post-op
Implant failure or periprosthetic fracture	30 days
Re-operation	30 days
New nursing home residence	30 days
First mobilization	30 days
FIM (motor function)	30 days

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Investigators: Principal Investigator: PJ Devereaux, PhD, Population Health Research Institute

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (Estimate): November 14, 2013

Study Record Updates

• Last Update Posted (Estimate): October 6, 2015
• Last Update Submitted That Met QC Criteria: October 5, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: HipVISION Pilot - 2013