Surgical Interventions for the Treatment of Humeral Shaft Fractures

October 4, 2017 updated by: Rafael Pierami, Federal University of São Paulo

Surgical Interventions for the Treatment of Humeral Shaft Fractures: Randomized Controlled Clinical Trial

This study intends to determine the best surgical treatment for humeral shaft fractures. One third of the patients will be treated with open reduction and internal fixation with plate; one third, with bridge plate technique and the remaining third with locked intramedullary nail.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Humerus diaphyseal fractures are amongst the most common of the appendicular skeleton. Despite the fact that the conservative treatment is still the gold standard for the majority of these fractures, this method was not proven to be superior when compared to the surgical treatment. Surgical options for the treatment of humeral shaft fractures range from open reduction and internal fixation with plate to minimally invasive methods (bridge plate and intramedullary nail) and the best method has yet to be determined. The goal of this study is to determine the best surgical option for the treatment of humeral shaft fractures. For this, will be recruited 105 patients with humeral shaft fractures, wich will be allocated, randomly, in 3 distinct groups. Each patient will be submitted to one of three possible methods of humerus osteosynthesis: open reduction and internal fixation with plate (ORIF), closed reduction and fixation with bridge plate or closed reduction and fixation with intramedullary nail. All data will be paired according to the age, gender, fracture classification, patient comorbidities and smoking habit. The Pearson's chi-square" test will be used to analyze the results of the three groups regarding categorical variables, and Student t-test (parametric) will be used to compare groups with respect to the numerical variables. The investigators expect to conclude that the methods of minimally invasive osteosynthesis of humeral shaft fractures have similar or better functional and radiographic outcomes, compared to the method of open reduction and internal fixation with a plate, with lesser risk of complications and an earlier return to activities.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

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

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Complete fracture with angulation greater than 20 degrees, rotation greater than 30 degrees and/or shortening greater than 3 cm.
  • Fractures located from 4 cm distal to the surgical neck to 2 cm proximal to the end of the medullary canal.

Exclusion Criteria:

  • fractures older than 3 weeks
  • pathologic fractures
  • fractures with extension to elbow or shoulder joint
  • patients with ipsilateral upper extremity fracture or injury
  • fractures with associated neurologic injury
  • patients with previous pathology of the shoulder, arm or elbow that cause pain or range of motion limitation
  • patients who do not agree with the terms of the study

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Open reduction and plate osteosynthesis
Open reduction and internal fixation with DCP 4.5mm plate.
Procedure: Open reduction and plate osteosynthesis
Trough an posterior or anterolateral approach, the fracture will be directly reduced and fixed with a broad DCP 4.5mm plate.
Other Names:
  • ORIF
Experimental: Bridge Plate
Patients will be submitted to closed reduction and anterior bridge plate osteosynthesis (narrow 4.5mm DCP plate will be used)
Procedure: Bridge Plate osteosynthesis
Trough two anterior skin incisions, the 4.5mm narrow DCP plate will be placed on the anterior surface of the humerus and, after indirect reduction, it will be fixed to the bone with 2 proximal and 2 distal screws.
Other Names:
  • Bridge Plate
Experimental: Intramedullary nail
Patients will be submitted to closed reduction and locked intramedullary nail osteosynthesis.
Procedure: Locked intramedullary nail osteosynthesis
Trough an anterolateral approach to the shoulder, the supraspinatus tendon will be longitudinally splited allowing the insertion of the intramedullary nail.
Other Names:
  • IMN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame: 48 weeks
The survey will be applied at 8, 24 and 48 weeks after the intervention
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Visual Analog Scale for Pain (VAS)
Time Frame: 48 weeks
The VAS survey will be applied 1, 8, 24 and 48 weeks after the intervention
48 weeks
Changes in the Constant-Murley Shoulder Outcome Score
Time Frame: 48 weeks
The Score will be obtained at 8, 24 and 48 weeks after the intervention
48 weeks
Complications (nonunion, symptomatic malunion, hardware related issues, shoulder pain, infection, neurological injury and loss of range of motion of shoulder and/or elbow)
Time Frame: 48 weeks
Complications are defined as nonunion, symptomatic malunion, hardware related issues, shoulder pain, infection, neurological injury and loss of range of motion of shoulder and/or elbow.
48 weeks
Radiographic angular deformity
Time Frame: at 48 weeks
Radiographic angular residual deformity will be measured at 48 weeks after the surgical procedure.
at 48 weeks
Time to previous activities return
Time Frame: 48 weeks
time to return to previous acitivities will bem described in weeks after the surgery
48 weeks
Failure (need for aditional surgical procedure)
Time Frame: 48 weeks
Failure is described as need for aditional surgical procedure.
48 weeks

Collaborators and Investigators

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

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Rafael Pierami, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2014

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 15, 2015

First Posted (Estimate)

April 16, 2015

Study Record Updates

Last Update Posted (Actual)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 4, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24997313.8.0000.5505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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