Audit of Hip Fractures Surgically Managed | NCT04187261

Studies
Audit of Hip Fractures Surgically Managed

NCT04187261

Sponsor

Aga Khan University

Status

Recruiting

Last Update Posted

Dec 13, 2019Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Hip Fractures

Interventions

hip fracture surgeries

Countries

Pakistan

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

Dec 2019

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2010Actual

Primary Completion Date

Dec 31, 2030Estimated

Completion Date

Dec 31, 2030Estimated

First Submitted Date

Dec 3, 2019

First Submission Date that Met QC Criteria

Dec 4, 2019

First Posted Date

Dec 5, 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

Dec 11, 2019

Last Update Posted Date

Dec 13, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Obada Hasan, FCPS, MRCS, MSc (Epidemiology&Biostatistics), Primary Investigator, Aga Khan UniversityPrincipal Investigator

Lead Sponsor

Aga Khan UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Investigators are reviewing the the charts and medical records of participants who were operated at our institute from 2010 onward for hip fractures. Checking their outcomes (Postoperative complications, length of hospital stay and mortality) and studying their background characteristics and potential associated factors.

Detailed Description

This retrospective study is a cohort with multiple exposures and groups. From this nested case control will be analysed as well.

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

2,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
hip fracture surgeries	Procedure	fixation or replacement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative complications	minor or major, in-hospital or within 30 days postoperativel	30 days postoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients, regardless of gender, commodities and age
Hip fractures which were managed surgically.
operated at our institute.

Exclusion Criteria:

Participants with incomplete data or missing information in either the primary exposure or the outcome of interest.
Participants with pathological fracture, open fractures, poly-trauma or revision surgeries.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

mostly elderly with hi fractures. However we included young patients as well.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Obada Hasan, FCPS,MSc	Contact	3193567121		obada.husseinali@aku.edu
aziz hayder, bachelor	Contact	02134864350	4350	aziz.hayder@aku.edu

Overall Officials

Name	Affiliation	Role
Obada Hasan, FCPS, MSc	Aga Khan Univeristy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aga Khan University	Recruiting	Karachi	Sindh	74800	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

not allowed by organisation

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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