Retrospective Analysis on Distal Humerus Fractures | NCT03637621

Studies
Retrospective Analysis on Distal Humerus Fractures

NCT03637621

Sponsor

The Orthopaedic Research & Innovation Foundation

Status

Unknown status

Last Update Posted

Oct 25, 2019Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Distal Humerus Fracture

Interventions

ORIF

Countries

United States

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

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2018Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Jul 24, 2018

First Submission Date that Met QC Criteria

Aug 14, 2018

First Posted Date

Aug 20, 2018Actual

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

Oct 23, 2019

Last Update Posted Date

Oct 25, 2019Actual

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

The purpose of this study is to evaluate preoperative objective measurements for distal humerus ORIF patients and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.

Detailed Description

Not provided

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

60Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ORIF	Other	open reduction internal fixation of the distal humerus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
total operative time	minutes	preoperative to up to 8 years postoperative
amount of blood loss	mls	preoperative to up to 8 years postoperative

Secondary Outcomes

Measure	Description	Time Frame
Patient Outcomes	American Shoulder and Elbow Surgeon score to measure shoulder function and pain. Scale of 0-100, 100 being the best possible score	preoperative to up to 8 years postoperative
Patient Outcomes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

English speaking
>18 years of age
Open reduction internal fixation surgical management of a distal humeral fracture performed by principal investigator at St. Elizabeth Healthcare

Exclusion Criteria:

Non-English speaking
<18 years of age

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All eligible patients of the names principal investigator receiving open reduction and internal fixation of the distal humerus for any indication at St. Elizabeth Healthcare on or after January 1, 2010 will be evaluated and included in the data analysis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
R M Greiwe, MD	The Orthopaedic Research & Innovation Foundation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Orthopaedic Research & Innovation Foundation		Edgewood	Kentucky	41017	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000092483	Humeral Fractures, Distal

Ancestor Terms

ID	Term
D000092482	Elbow Fractures
D000092464	Elbow Injuries
D001134	Arm Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided