Fracture of Neck of Femur (Hip)HipMoNCT01807039
Mortality Following Surgery for Proximal Femoral Fractures
An observational study of Fracture of Neck of Femur (Hip), run by Brno University Hospital at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Fracture of Neck of Femur (Hip)
- What is being tested?
- hip fracture surgery
- Type of treatment
- Surgery or procedure
- How many people
- 369 participants
- Where
- 1 siteCzechia
- Study dates
- Dec 2012to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: isolated fracture of proximal femur indicated for surgery
Who may be able to join
- isolated fracture of proximal femur indicated for surgery
Who cannot join
- children under 18 years
- none isolated trauma
- isolated fracture of proximal femur without surgery
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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)
- Conditions
- Fracture of Neck of Femur (Hip)
- Being tested
- hip fracture surgery
- Keywords
- hip fracture, proximal femur, pertrochanteric fracture, subtrochanteric fracture, subcapital fracture, safety issue, anesthesia
- Medical subject headings
- Femoral Neck Fractures, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip fracture surgeryProcedure or surgery
we evaluate the relationship between the monitored parameters and 30 day survival
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: hip fracture surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
in hospital mortality rate
number of deaths from hospital admission to discharge (percent)
Measured: 2 years
Secondary outcomes (1)
30 days mortality rate
number of deaths within 30 days after injury (percent)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fracture of Neck of Femur (Hip)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Štourač, MD, Ph.D., Study director, Brno Faculty Hospital, departement of anesthesiology and intensive care medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807039
- Sponsor's protocol ID
- KARIM FN Brno
- Acronym
- HipMo
- Status last verified
- Jul 2016
- First submitted
- 6 Mar 2013
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10754613Pearse 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.
PubMed 22998715Dzupa 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.
PubMed 11951568
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality Following Surgery for Proximal Femoral Fractures
- ClinicalTrials.gov ID
- NCT01807039
- Acronym / sponsor ID
- HipMo / KARIM FN Brno
- Conditions
- Fracture of Neck of Femur (Hip)
- Keywords
- hip fracture, proximal femur, pertrochanteric fracture, subtrochanteric fracture, subcapital fracture, safety issue, anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- St. Anne's University Hospital Brno, Czech Republic
- Study start
- Dec 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients after surgery with isolated proximal femur fracture | – | Procedure: hip fracture surgeryPatients 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). |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- isolated fracture of proximal femur indicated for surgery
Key inclusion criteria (1 listed)
- isolated fracture of proximal femur indicated for surgery
Key exclusion criteria (3 listed)
- children under 18 years
- none isolated trauma
- isolated fracture of proximal femur without surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hip fracture surgerywe evaluate the relationship between the monitored parameters and 30 day survival | Procedure or surgery | patients after surgery with isolated proximal femur fracture |
Primary outcome
in hospital mortality rate
Time frame: 2 years
number of deaths from hospital admission to discharge (percent)
1 secondary outcome
30 days mortality rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Background: PubMed 10754613O'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.
- Background: PubMed 22998715Pearse 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.
- Background: PubMed 11951568Dzupa 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.
- open access link to full-textLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Štourač, MD, Ph.D. study director
Brno Faculty Hospital, departement of anesthesiology and intensive care medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture of Neck of Femur (Hip), run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in hospital mortality rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01807039, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.