Posterior Minimally Invasive Plate Osteosynthesis (MIPO) for Humerus Diaphyseal Fractures (MIPOH)

March 11, 2020 updated by: Julio Contreras, Instituto Traumatologico Dr. Teodoro Gebauer Weisser

Posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Clinical

  • Pain
  • ROM

Functional

  • Constant Score
  • MEPS
  • QuickDASH

Radiological

- Bone union

Complications

  • Infection
  • Nerve injury

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 7510664
        • Recruiting
        • Instituto Traumatologico
        • Contact:
        • Principal Investigator:
          • Julio Contreras, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
MIPO with Extra-articular Distal Humeral Anatomical Plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone union
Time Frame: 6 months
Radiological Bone union (X-ray or CT)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain (Quantity)
Time Frame: 1 month, 6 months, 1 year
Visual Analog Scale
1 month, 6 months, 1 year
Range of Motion (Degrees of flexion, extension, pronation and supination)
Time Frame: 1 month, 6 months, 1 year
Physical Exam
1 month, 6 months, 1 year
Constant Score
Time Frame: 1 month, 6 months, 1 year
Score
1 month, 6 months, 1 year
Mayo Elbow Score
Time Frame: 1 month, 6 months, 1 year
Score
1 month, 6 months, 1 year
Quick Disabilities of the Arm, Shoulder and Hand
Time Frame: 1 month, 6 months, 1 year
Score
1 month, 6 months, 1 year
Radial nerve injury
Time Frame: 1 month, 6 months, 1 year
Physical exam (electromyography when needed)
1 month, 6 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Traumatologico Dr. Teodoro Gebauer Weisser

Collaborators

University of Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

March 11, 2020

First Posted (Actual)

March 13, 2020

Study Record Updates

Last Update Posted (Actual)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIPOH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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