Predictive Model for Postoperative Complications in Hemi-... | NCT03375268

Studies
Predictive Model for Postoperative Complications in Hemi-hip Arthroplasty

NCT03375268

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Dec 18, 2017Actual

Enrollment

460Estimated

Phase

Not provided

Conditions

Complication
Risk Factor
Elderly Patient
Arthroplasty

Interventions

Not provided

Countries

South Korea

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 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2011Actual

Primary Completion Date

Dec 31, 2015Actual

Completion Date

Aug 31, 2018Estimated

First Submitted Date

Dec 12, 2017

First Submission Date that Met QC Criteria

Dec 12, 2017

First Posted Date

Dec 18, 2017Actual

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 12, 2017

Last Update Posted Date

Dec 18, 2017Actual

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

The purpose of this study was to identify the major complications and their risk factors of elderly patients who had undergone Hemi-hip Arthroplasty.

Detailed Description

We retrospectively reviewed the medical records and reviewed the major complications and identify risk factors of elderly patients who had undergone Hemi-hip Arthroplasty for adults aged 60 years or older from January 2011 to December 2015.

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

460Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative complications	we collect postoperative complications which include cardiac, pulmonary renal, cerebral, and other complications.	from operation day to postoperative 30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A patient scheduled to undergo spinal anesthesia for Hemi-hip Arthroplasty

Exclusion Criteria:

1) Patients with acute infectious disease before surgery 2) Patients with fractures around the implant 3) Patients who underwent reoperation during hospitalization 4) During the study period, Duplicate patient who underwent the opposite side of the hip during hospitalization

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

From January 2011 to December 2015, we will enroll adult patients aged 60 years or older who underwent Hemi-hip Arthroplasty at our institution.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eunsu Choi, pf	Contact	821032990658		potterydoll@hanmail.net
Sojin SHin, Dr	Contact	8229708404		potterydoll@gmail.com

Overall Officials

Name	Affiliation	Role
Eunsu Choi, pf	Eulji University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eulji university hospital	Recruiting	Seoul		01830	South Korea