Surgical Interventions for the Treatment of Humeral Shaft Fractures

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fracture of Shaft of Humerus, Humerus Fracture

Intervention / Treatment
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* Procedure: Bridge Plate osteosynthesis
* Procedure: Locked intramedullary nail osteosynthesis
* Procedure: Open reduction and plate osteosynthesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open reduction and plate osteosynthesis<br>Open reduction and internal fixation with DCP 4.5mm plate. | Procedure: Open reduction and plate osteosynthesis<br>* Trough an posterior or anterolateral approach, the fracture will be directly reduced and fixed with a broad DCP 4.5mm plate.<br>* Other names: ORIF;|
| Experimental: Bridge Plate<br>Patients will be submitted to closed reduction and anterior bridge plate osteosynthesis (narrow 4.5mm DCP plate will be used) | Procedure: Bridge Plate osteosynthesis<br>* 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.<br>* Other names: Bridge Plate;|
| Experimental: Intramedullary nail<br>Patients will be submitted to closed reduction and locked intramedullary nail osteosynthesis. | Procedure: Locked intramedullary nail osteosynthesis<br>* Trough an anterolateral approach to the shoulder, the supraspinatus tendon will be longitudinally splited allowing the insertion of the intramedullary nail.<br>* Other names: IMN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Visual Analog Scale for Pain (VAS) | 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 | 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) | 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 | Radiographic angular residual deformity will be measured at 48 weeks after the surgical procedure. | at 48 weeks | 
| Time to previous activities return | time to return to previous acitivities will bem described in weeks after the surgery | 48 weeks | 
| Failure (need for aditional surgical procedure) | Failure is described as need for aditional surgical procedure. | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Humerus, shaft, diaphyseal, fractures