Risk Factors and Complications Contributing to Mortality... | NCT03822000

Studies
Risk Factors and Complications Contributing to Mortality in Elderly Patients With Fall-Induced Femoral Fracture

NCT03822000

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Jan 30, 2019Actual

Enrollment

2,407Actual

Phase

Not provided

Conditions

Femoral Fractures

Interventions

Survival
Death

Countries

Taiwan

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

Jan 2019

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

Jan 11, 2019Actual

Primary Completion Date

Jan 28, 2019Actual

Completion Date

Jan 28, 2019Actual

First Submitted Date

Jan 28, 2019

First Submission Date that Met QC Criteria

Jan 28, 2019

First Posted Date

Jan 30, 2019Actual

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

Jan 28, 2019

Last Update Posted Date

Jan 30, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

This study aimed to identify the risk factors and complications associated with mortality in elderly patients with femoral fracture after a fall from the ground level.

Detailed Description

This retrospective study reviewed data pertaining to elderly patients aged ≥ 65 years who were admitted into a Level I trauma center, between January 1, 2009 and December 31, 2017. Multivariate logistic regression analysis was performed to identify independent effects of univariate predictive variables on the occurrence of mortality.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

2,407Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elderly Patients with Femoral Fracture		Elderly patients with fall-induced femoral fracture. Patients were categorized into two groups: death (n = 42) and survival (n = 2,365).	Other: Survival Other: Death

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Survival	Other	Elderly patients with fall-induced femoral fracture who were survived.	Elderly Patients with Femoral Fracture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Mortality was used as the primary outcome.	up tp 2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a fall from ≥1 m as well as those for whom incomplete data were available.

Exclusion Criteria:

those patients with a fall from ≥1 m
patients with incompleted data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

100 Years

Standard Ages

Older Adult

Study Population

This retrospective study reviewed data from 27,462 trauma patients registered between January 1, 2009 and December 31, 2016. The inclusion criteria were age ≥65 years and hospitalization for the treatment of femoral fracture following a fall from standing height level (<1 m). This study excluded those patients with a fall from ≥1 m as well as those for whom incomplete data were available.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Chang Gung Memorial Hospital		Kaohsiung City		83301	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D005264	Femoral Fractures
D014947	Wounds and Injuries

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D007869	Leg Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000071459	Death Domain

Ancestor Terms

ID	Term
D000071458	Death Domain Superfamily
D054730	Protein Interaction Domains and Motifs
D000072417	Protein Domains
D000072416	Protein Structural Elements

Browse Leaves

Not provided

Browse Branches

Not provided