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Surgical Interventions for the Treatment of Humeral Shaft Fractures

Primary Purpose

Fracture of Shaft of Humerus, Humerus Fracture

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Bridge Plate osteosynthesis
Locked intramedullary nail osteosynthesis
Open reduction and plate osteosynthesis
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture of Shaft of Humerus focused on measuring Humerus, shaft, diaphyseal, fractures

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hand and Upper Limb Surgery DisciplineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Open reduction and plate osteosynthesis

Bridge Plate

Intramedullary nail

Arm Description

Open reduction and internal fixation with DCP 4.5mm plate.

Patients will be submitted to closed reduction and anterior bridge plate osteosynthesis (narrow 4.5mm DCP plate will be used)

Patients will be submitted to closed reduction and locked intramedullary nail osteosynthesis.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 8, 2015
Last Updated
October 4, 2017
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02418260
Brief Title
Surgical Interventions for the Treatment of Humeral Shaft Fractures
Official Title
Surgical Interventions for the Treatment of Humeral Shaft Fractures: Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Shaft of Humerus, Humerus Fracture
Keywords
Humerus, shaft, diaphyseal, fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open reduction and plate osteosynthesis
Arm Type
Active Comparator
Arm Description
Open reduction and internal fixation with DCP 4.5mm plate.
Arm Title
Bridge Plate
Arm Type
Experimental
Arm Description
Patients will be submitted to closed reduction and anterior bridge plate osteosynthesis (narrow 4.5mm DCP plate will be used)
Arm Title
Intramedullary nail
Arm Type
Experimental
Arm Description
Patients will be submitted to closed reduction and locked intramedullary nail osteosynthesis.
Intervention Type
Procedure
Intervention Name(s)
Bridge Plate osteosynthesis
Other Intervention Name(s)
Bridge Plate
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Locked intramedullary nail osteosynthesis
Other Intervention Name(s)
IMN
Intervention Description
Trough an anterolateral approach to the shoulder, the supraspinatus tendon will be longitudinally splited allowing the insertion of the intramedullary nail.
Intervention Type
Procedure
Intervention Name(s)
Open reduction and plate osteosynthesis
Other Intervention Name(s)
ORIF
Intervention Description
Trough an posterior or anterolateral approach, the fracture will be directly reduced and fixed with a broad DCP 4.5mm plate.
Primary Outcome Measure Information:
Title
Changes in the Disabilities of the Arm, Shoulder and Hand (DASH)
Description
The survey will be applied at 8, 24 and 48 weeks after the intervention
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Changes in the Visual Analog Scale for Pain (VAS)
Description
The VAS survey will be applied 1, 8, 24 and 48 weeks after the intervention
Time Frame
48 weeks
Title
Changes in the Constant-Murley Shoulder Outcome Score
Description
The Score will be obtained at 8, 24 and 48 weeks after the intervention
Time Frame
48 weeks
Title
Complications (nonunion, symptomatic malunion, hardware related issues, shoulder pain, infection, neurological injury and loss of range of motion of shoulder and/or elbow)
Description
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.
Time Frame
48 weeks
Title
Radiographic angular deformity
Description
Radiographic angular residual deformity will be measured at 48 weeks after the surgical procedure.
Time Frame
at 48 weeks
Title
Time to previous activities return
Description
time to return to previous acitivities will bem described in weeks after the surgery
Time Frame
48 weeks
Title
Failure (need for aditional surgical procedure)
Description
Failure is described as need for aditional surgical procedure.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafael Pierami, M.D.
Phone
+5511982325308
Email
rafael_pierami@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marcel JS Tamaoki, Ph.D.
Phone
+5511941713337
Email
marceltamaoki@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Pierami
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hand and Upper Limb Surgery Discipline
City
Sao Paulo
ZIP/Postal Code
04038001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Pierami, M.D.
Phone
+5511982325308
Email
rafael_pierami@hotmail.com
First Name & Middle Initial & Last Name & Degree
Marcel JS Tamaoki, Ph.D.
Phone
+5511941713337
Email
marceltamaoki@terra.com.br

12. IPD Sharing Statement

Plan to Share IPD
Yes
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Surgical Interventions for the Treatment of Humeral Shaft Fractures

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