Femoral Neck FractureNCT02202122
Interest of the OSA (Obstructive Sleep Apnea) Predictive Scores in the Prognosis of Postoperative Mortality of Femoral Neck Fractures
An observational study of Femoral Neck Fracture, run by Astes at 1 site in Belgium.
Trial summary
Interest of the four major OSA Predictive Scores (STOP-BANG, P-SAP, DES-OSA, OSA50) in the prognosis of postoperative mortality after femoral neck fracture. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Femoral Neck Fracture
- What is being tested?
- OSA Scoring
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2014to Oct 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 with femoral neck fractures
Who may be able to join
- All patients with femoral neck fractures
- Incoming at the Saint-Luc Bouge Hospital
- Between 15/09/2014 and 15/10/2015
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of the OSA (Obstructive Sleep Apnea) Predictive Scores in the Prognosis of Postoperative Mortality of Femoral Neck Fractures.
Interest of the four major OSA Predictive Scores (STOP-BANG, P-SAP, DES-OSA, OSA50) in the prognosis of postoperative mortality after femoral neck fracture.
Read the detailed description
- All patients incoming at the Saint-Luc Bouge Hospital with a femoral neck fracture
- Study between 15/09/2014 and 15/10/2015
- The four OSA predictive scores will be collected
- Evaluation of mortality at 1 month
- Conditions
- Femoral Neck Fracture
- Being tested
- OSA Scoring
- Keywords
- Femoral Neck Fractures, Obstructive Sleep Apnea, Perioperative Complications
- Medical subject headings
- Femoral Neck Fractures, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSA ScoringOther
Comparison of the preoperative OSA scoring (STOP-BANG, DES-OSA, P-SAP and OSA50) with the postoperative mortality at one month.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | OSA Scoring Receives: Other: OSA Scoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact OSA predictive scores on mortality prognosis
Impact of the four major OSA predictive scores (STOP-BANG, P-SAP, OSA50 et DES-OSA) on the mortality prognosis after surgery for femoral neck fracture
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 posted28 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2015 (estimated)
- Study completionOct 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 FractureStudies 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
- NCT02202122
- Sponsor's protocol ID
- FNF-OSA
- Status last verified
- Jun 2015
- First submitted
- 25 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
- Interest of the OSA (Obstructive Sleep Apnea) Predictive Scores in the Prognosis of Postoperative Mortality of Femoral Neck Fractures.
- ClinicalTrials.gov ID
- NCT02202122
- Acronym / sponsor ID
- FNF-OSA
- Conditions
- Femoral Neck Fracture
- Keywords
- Femoral Neck Fractures, Obstructive Sleep Apnea, Perioperative Complications
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: lack of investigators
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstesUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 28 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.
Interest of the four major OSA Predictive Scores (STOP-BANG, P-SAP, DES-OSA, OSA50) in the prognosis of postoperative mortality after femoral neck fracture.
Detailed description
- All patients incoming at the Saint-Luc Bouge Hospital with a femoral neck fracture
- Study between 15/09/2014 and 15/10/2015
- The four OSA predictive scores will be collected
- Evaluation of mortality at 1 month
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: OSA ScoringOSA Scoring |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with femoral neck fractures
Key inclusion criteria (3 listed)
- All patients with femoral neck fractures
- Incoming at the Saint-Luc Bouge Hospital
- Between 15/09/2014 and 15/10/2015
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 |
|---|---|---|
| OSA ScoringComparison of the preoperative OSA scoring (STOP-BANG, DES-OSA, P-SAP and OSA50) with the postoperative mortality at one month. | Other | Study Group |
Primary outcome
Impact OSA predictive scores on mortality prognosis
Time frame: 1 month
Impact of the four major OSA predictive scores (STOP-BANG, P-SAP, OSA50 et DES-OSA) on the mortality prognosis after surgery for femoral neck fracture
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 Fracture, 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 3 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?
Impact OSA predictive scores on mortality prognosis (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.