Femoral Neck FracturesNCT02198820
Practice Survey on Femoral Neck Fractures and the Incidence of Type of Anesthesia on Patient Outcome
An observational study of Femoral Neck Fractures, run by Astes at 1 site in Belgium.
Trial summary
Inclusion of all patients with femoral neck fracture presenting in Saint-Luc Bouge Hospital between October 1th 2014 and September 30th 2015. Comparison of severity scores of these patients and the scale of Nottingham on immediate (day 1 and day 2) and late (1 month) outcome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- General Anesthesia and Loco Regional Anesthesia
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2014to Sep 2015
- How long will I take part?
- 1 Month
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients admitted at the Saint-Luc Bouge Hospital for a femoral neck fractures
Who may be able to join
- All patients admitted at the Saint-Luc Bouge Hospital for a femoral neck fractures between 10/01/2014 and 30/09/2014
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Practice Survey on Femoral Neck Fractures and the Incidence of Type of Anesthesia on Patient Outcome in the Saint-Luc Bouge Hospital
Inclusion of all patients with femoral neck fracture presenting in Saint-Luc Bouge Hospital between October 1th 2014 and September 30th 2015.
Comparison of severity scores of these patients and the scale of Nottingham on immediate (day 1 and day 2) and late (1 month) outcome.
Read the detailed description
Inclusion of all patients with femoral neck fracture presenting in Saint-Luc Bouge Hospital between October 1th 2014 and September 30th 2015.
Comparison of severity scores of these patients and the scale of Nottingham on immediate (day 1 and day 2) and late (1 month) outcome.
This comparison includes preoperative parameters (hemoglobin, creatinine, mini-mental test) and intraoperative parameters (such as type of anesthesia).
- Conditions
- Femoral Neck Fractures
- Being tested
- General Anesthesia, Loco Regional Anesthesia
- Keywords
- Femoral Neck Fractures, Perioperative Care, Perioperative Period, Postoperative Complications
- Medical subject headings
- Femoral Neck Fractures, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General AnesthesiaDrug
General anesthesia with proposal, rocuronium and sufentanil
Loco Regional AnesthesiaDrug
Loco Regional Anesthesia with marcaine
| Study group | Role | What they receive |
|---|---|---|
| General | All patients included who underwent surgery with general anesthesia Receives: Drug: General Anesthesia | |
| Loco Regional | All patients included who underwent surgery with loco regional anesthesia Receives: Drug: Loco Regional Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative assessment
Comparison of the impact of preoperative parameters (such as hemoglobin, creatinine, mini-mental test) on patient outcome.
Measured: 1 month
Secondary outcomes (1)
Perioperative assessment
Comparison of the impact of the type of anesthesia (general versus loco regional) on patient outcome.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Why it stopped: lack of investigators
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Astes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric DEFLANDRE, MD, FCCP, Astes
- Investigators
- Eric P DEFLANDRE, MD, FCCP, Principal investigator, Astes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198820
- Sponsor's protocol ID
- FNF-SLBO
- Status last verified
- Jun 2015
- First submitted
- 23 Jul 2014
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice Survey on Femoral Neck Fractures and the Incidence of Type of Anesthesia on Patient Outcome in the Saint-Luc Bouge Hospital
- ClinicalTrials.gov ID
- NCT02198820
- Acronym / sponsor ID
- FNF-SLBO
- Conditions
- Femoral Neck Fractures
- Keywords
- Femoral Neck Fractures, Perioperative Care, Perioperative Period, Postoperative Complications
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: lack of investigators
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstesUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 24 Jul 2014 (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.
Inclusion of all patients with femoral neck fracture presenting in Saint-Luc Bouge Hospital between October 1th 2014 and September 30th 2015.
Comparison of severity scores of these patients and the scale of Nottingham on immediate (day 1 and day 2) and late (1 month) outcome.
Detailed description
Inclusion of all patients with femoral neck fracture presenting in Saint-Luc Bouge Hospital between October 1th 2014 and September 30th 2015.
Comparison of severity scores of these patients and the scale of Nottingham on immediate (day 1 and day 2) and late (1 month) outcome.
This comparison includes preoperative parameters (hemoglobin, creatinine, mini-mental test) and intraoperative parameters (such as type of anesthesia).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General | – | Drug: General AnesthesiaAll patients included who underwent surgery with general anesthesia |
| Loco Regional | – | Drug: Loco Regional AnesthesiaAll patients included who underwent surgery with loco regional anesthesia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted at the Saint-Luc Bouge Hospital for a femoral neck fractures
Key inclusion criteria (1 listed)
- All patients admitted at the Saint-Luc Bouge Hospital for a femoral neck fractures between 10/01/2014 and 30/09/2014
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| General AnesthesiaGeneral anesthesia with proposal, rocuronium and sufentanil | Drug | General |
| Loco Regional AnesthesiaLoco Regional Anesthesia with marcaine | Drug | Loco Regional |
Primary outcome
Preoperative assessment
Time frame: 1 month
Comparison of the impact of preoperative parameters (such as hemoglobin, creatinine, mini-mental test) on patient outcome.
1 secondary outcome
Perioperative assessment
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
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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.
Eric P DEFLANDRE, MD, FCCP principal investigator
Astes
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 Femoral Neck Fractures, run by Astes at 1 site in Belgium.
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 1 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: withdrawn, as of the sponsor's last update on 23 Jun 2015. 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 Belgium. 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 was withdrawn before enrolling participants, so there are no results.
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?
Preoperative assessment (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2015.