Practice Survey on Femoral Neck Fractures and the Inciden... | NCT02198820

Studies
Practice Survey on Femoral Neck Fractures and the Incidence of Type of Anesthesia on Patient Outcome

NCT02198820

Sponsor

Astes

Status

Withdrawn

Last Update Posted

Jun 23, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Femoral Neck Fractures

Interventions

General Anesthesia
Loco Regional Anesthesia

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of investigators

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Sep 2015Estimated

Completion Date

Sep 2015Estimated

First Submitted Date

Jul 23, 2014

First Submission Date that Met QC Criteria

Jul 23, 2014

First Posted Date

Jul 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2015

Last Update Posted Date

Jun 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
General		All patients included who underwent surgery with general anesthesia	Drug: General Anesthesia
Loco Regional		All patients included who underwent surgery with loco regional anesthesia	Drug: Loco Regional Anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
General Anesthesia	Drug	General anesthesia with proposal, rocuronium and sufentanil	General

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Preoperative assessment	Comparison of the impact of preoperative parameters (such as hemoglobin, creatinine, mini-mental test) on patient outcome.	1 month

Secondary Outcomes

Measure	Description	Time Frame
Perioperative assessment	Comparison of the impact of the type of anesthesia (general versus loco regional) on patient outcome.	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients admitted at the Saint-Luc Bouge Hospital for a femoral neck fractures between 10/01/2014 and 30/09/2014

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients admitted at the Saint-Luc Bouge Hospital for a femoral neck fractures

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric P DEFLANDRE, MD, FCCP	Astes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Saint-Luc de Bouge		Namur	Namur	5004	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D005265	Femoral Neck Fractures
D011183	Postoperative Complications

Ancestor Terms

ID	Term
D006620	Hip Fractures
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000768	Anesthesia, General

Ancestor Terms

ID	Term
D000758	Anesthesia
D000760	Anesthesia and Analgesia

Browse Leaves

Not provided

Browse Branches

Not provided