NCT01807039

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
369

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

2.4 years

First QC Date

March 6, 2013

Last Update Submit

July 22, 2016

Conditions

Keywords

hip fractureproximal femurpertrochanteric fracturesubtrochanteric fracturesubcapital fracturesafety issueanesthesia

Outcome Measures

Primary Outcomes (1)

  • in hospital mortality rate

    number of deaths from hospital admission to discharge (percent)

    2 years

Secondary Outcomes (1)

  • 30 days mortality rate

    2 years

Study Arms (1)

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).

Procedure: hip fracture surgery

Interventions

we evaluate the relationship between the monitored parameters and 30 day survival

patients after surgery with isolated proximal femur fracture

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

isolated fracture of proximal femur indicated for surgery

You may qualify if:

  • isolated fracture of proximal femur indicated for surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Hospital Brno

Brno, South Moravian, 62500, Czechia

Location

Related Publications (3)

  • O'Hara DA, Duff A, Berlin JA, Poses RM, Lawrence VA, Huber EC, Noveck H, Strom BL, Carson JL. The effect of anesthetic technique on postoperative outcomes in hip fracture repair. Anesthesiology. 2000 Apr;92(4):947-57. doi: 10.1097/00000542-200004000-00011.

    PMID: 10754613BACKGROUND
  • Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.

    PMID: 22998715BACKGROUND
  • Dzupa V, Bartonicek J, Skala-Rosenbaum J, Prikazsky V. [Mortality in patients with proximal femoral fractures during the first year after the injury]. Acta Chir Orthop Traumatol Cech. 2002;69(1):39-44. Czech.

    PMID: 11951568BACKGROUND

Related Links

MeSH Terms

Conditions

Femoral Neck FracturesHip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Petr Štourač, MD, Ph.D.

    Brno Faculty Hospital, departement of anesthesiology and intensive care medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D.

Study Record Dates

First Submitted

March 6, 2013

First Posted

March 8, 2013

Study Start

December 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations