Mortality Following Surgery for Proximal Femoral Fractures (HipMo)

July 22, 2016 updated by: Petr Štourač, MD, Brno University Hospital
Proximal femoral fractures are most frequent traumatologic and orthopedic diagnoses undergoing surgery. It affect most seniors and accompanied by a series of complications. The aim of our retrospective clinical trial is to establish a thirty-day mortality rate after surgical solutions, mortality during hospitalization and compare the types of anesthesia chosen during the performance (general vs. subarachnoid anesthesia).

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

We evaluate relationship between the monitored parameters and 30 day survival.

Observed parameters:

  • age of the patient
  • sex of the patient
  • 90 days mortality rate
  • American Society of Anesthesiologists (ASA) score
  • time since injury and surgery (hours)
  • whether surgery was initiated during the day (7:00 - 20:00) or at night (20:00-07:00)
  • type of administered anesthesia (GA, epidural anaesthesia, Subarachnoid (spinal) block)
  • hemoglobin level prior to surgery
  • haemotransfusion administration during surgery
  • perioperative administration of vasopressors
  • anesthetist erudition (with / without accomplished residency)
  • surgeon erudition (with / without accomplished residency)

Study Type

Observational

Enrollment (Actual)

369

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jihomoravský Kraj
      • Brno, Jihomoravský Kraj, Czech Republic, 62500
        • Faculty hospital Brno

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

isolated fracture of proximal femur indicated for surgery

Description

Inclusion Criteria:

  • isolated fracture of proximal femur indicated for surgery

Exclusion Criteria:

  • children under 18 years
  • none isolated trauma
  • isolated fracture of proximal femur without surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients after surgery with isolated proximal femur fracture
Patients between 18-110 years admitted to Faculty Hospital Brno with isolated injury of proximal femur (ICD dg. S72.0 a S72.1)who underwent surgery between 1.1. 2011 00:00 - 31.12. 2012 23:59 in Faculty hospital Brno (tertiary care university hospital).
we evaluate the relationship between the monitored parameters and 30 day survival

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in hospital mortality rate
Time Frame: 2 years
number of deaths from hospital admission to discharge (percent)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 days mortality rate
Time Frame: 2 years
number of deaths within 30 days after injury (percent)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Petr Štourač, MD, Ph.D., Brno Faculty Hospital, departement of anesthesiology and intensive care medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

March 6, 2013

First Submitted That Met QC Criteria

March 7, 2013

First Posted (Estimate)

March 8, 2013

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 22, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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