Improving Quality of Care for Hip-Fracture Patients: Stud... | NCT01487772

Studies
Improving Quality of Care for Hip-Fracture Patients: Studies on Fast-track Surgery

NCT01487772

Sponsor

Danderyd Hospital

Status

Completed

Last Update Posted

Sep 19, 2014Estimated

Enrollment

1,307Actual

Phase

Not provided

Conditions

Hip Fractures

Interventions

Not provided

Countries

Sweden

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

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Dec 6, 2011

First Submission Date that Met QC Criteria

Dec 6, 2011

First Posted Date

Dec 7, 2011Estimated

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

Sep 18, 2014

Last Update Posted Date

Sep 19, 2014Estimated

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

The aims of the studies are to examine the impact of delayed time to surgery for hip-fracture patients with regard to in-hospital complication rate and one-year mortality and to evaluate two different fast-track systems for hip-fracture patients with regard to patient outcome, complication rate and patient satisfaction.

Detailed Description

The aims of the studies are to examine the impact of delayed time to surgery for hip-fracture patients with regard to in-hospital complication rate and one-year mortality and to evaluate two different fast-track systems, the hip process pathway and the ambulance process pathway, for hip-fracture patients with regard to patient outcome, complication rate and patient satisfaction.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,307Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hip-fracture patients		Hip-fracture patients admitted to Orthopaedic Department of Danderyd Hospital

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complication rate	The 3-month medical complication rate	3-months

Secondary Outcomes

Measure	Description	Time Frame
Mortality rate	One-year mortality rate	1-year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hip fracture

Exclusion Criteria:

Periprosthetic fractures
Pathological fractures

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 hip-fracture patients admitted to the Orthopaedic Department of Danderyd Hospital during a two-year period.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olof Skoldenebrg, MD, PhD	Danderyd Hospital, Stockholm, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danderyd Hospital		Stockholm		182 88	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D006620	Hip Fractures

Ancestor Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries

Browse Leaves

Not provided

Browse Branches

Not provided