NCT03637621

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

3 years

First QC Date

July 24, 2018

Last Update Submit

October 23, 2019

Conditions

Distal Humerus Fracture

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Patient Outcomes

    preoperative to up to 8 years postoperative

  • Patient Outcomes

    preoperative to up to 8 years postoperative

Interventions

ORIFOTHER

open reduction internal fixation of the distal humerus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Non-English speaking
  • \<18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Orthopaedic Research & Innovation Foundation

Edgewood, Kentucky, 41017, United States

Location

MeSH Terms

Conditions

Humeral Fractures, Distal

Condition Hierarchy (Ancestors)

Elbow FracturesElbow InjuriesArm InjuriesWounds and InjuriesHumeral FracturesFractures, Bone

Study Officials

  • R M Greiwe, MD

    The Orthopaedic Research & Innovation Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2018

First Posted

August 20, 2018

Study Start

January 7, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

October 25, 2019

Record last verified: 2019-10

Locations

US(1)