NCT04307342

Brief Summary

The primary objective is to evaluate the clinical, functional and radiological results in patients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

3 years

First QC Date

March 11, 2020

Last Update Submit

March 11, 2020

Conditions

Humerus Fracture

Keywords

humerusfractureosteosynthesis

Outcome Measures

Primary Outcomes (1)

  • Bone union

    Radiological Bone union (X-ray or CT)

    6 months

Secondary Outcomes (6)

  • Pain (Quantity)

    1 month, 6 months, 1 year

  • Range of Motion (Degrees of flexion, extension, pronation and supination)

    1 month, 6 months, 1 year

  • Constant Score

    1 month, 6 months, 1 year

  • Mayo Elbow Score

    1 month, 6 months, 1 year

  • Quick Disabilities of the Arm, Shoulder and Hand

    1 month, 6 months, 1 year

  • +1 more secondary outcomes

Study Arms (1)

Posterior MIPO

Patients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate

Procedure: MIPO with Extra-articular Distal Humeral Anatomical Plate

Interventions

MIPO with Extra-articular Distal Humeral Anatomical PlatePROCEDURE

MIPO with Extra-articular Distal Humeral Anatomical Plate

Posterior MIPO

Eligibility Criteria

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

Patients consulting in the emergency department of the Instituto Traumatológico for a fracture of the humerus

You may qualify if:

  • Closed diaphyseal humerus fracture at the junction of the middle third with distal

You may not qualify if:

  • Open fractures, proximal humerus extension, distal articular compromise, polytrauma, more than 2 weeks of trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Traumatológico

Santiago, Santiago Metropolitan, 7510664, Chile

RECRUITING

MeSH Terms

Conditions

Humeral FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shoulder and Elbow Surgeon

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 13, 2020

Study Start

July 1, 2018

Primary Completion

July 1, 2021

Study Completion

July 1, 2022

Last Updated

March 13, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share
Shared Documents
ICF, CSR

Locations

CL(1)