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

NCT ID: NCT01984385

Last Updated: 2015-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-10-31

Brief 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. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with a hip fracture

No interventions assigned to this group

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

P.J. Devereaux

MD, PhD, FRCP(C)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

PJ Devereaux, PhD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Locations

Juravinski Hospital and Cancer Centre (HHS)

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

HipVISION Pilot - 2013

Identifier Type: -

Identifier Source: org_study_id