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Completed

NCT Number: NCT01984385

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Juravinski Hospital and Cancer Centre (HHS)

Hamilton, Ontario, L8V 5C2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

Primary outcomes

  1. Total and cause specific mortality in hip fracture patients at 30 days

    Time frame: 30 days

  2. Major complications within 30 days.

    Time frame: 30 days

    Composite of vascular mortality, nonfatal MI, nonfatal stroke, nonfatal PE, sepsis, and life-threatening bleeding.

Secondary outcomes

  1. Nonfatal myocardial infarction

    Time frame: 30 days

  2. Nonfatal myocardial injury after noncardiac surgery

    Time frame: 30 days

  3. Nonfatal pulmonary embolism

    Time frame: 30 days

  4. Nonfatal infection

    Time frame: 30 days

  5. Nonfatal bleeding

    Time frame: 30 days

  6. Nonfatal stroke

    Time frame: 30 days

  7. New congestive heart failure

    Time frame: 30 days

  8. New atrial fibrillation

    Time frame: 30 days

  9. Nonfatal cardiac arrest

    Time frame: 30 days

  10. Deep vein thrombosis

    Time frame: 30 days

  11. New acute renal failure requiring dialysis

    Time frame: 30 days

  12. Cardiac catheterization

    Time frame: 30 days

  13. PCI

    Time frame: 30 days

  14. CABG

    Time frame: 30 days

  15. CAM days 1-7 post-op

    Time frame: 1-7 days post-op

  16. Implant failure or periprosthetic fracture

    Time frame: 30 days

  17. Re-operation

    Time frame: 30 days

  18. Length of hospital stay

    Time frame: 30 days

  19. New nursing home residence

    Time frame: 30 days

  20. First mobilization

    Time frame: 30 days

  21. FIM (motor function)

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Nov 14, 2013
Registry last updated
Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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