NCT02418260

Surgical Interventions for the Treatment of Humeral Shaft Fractures

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fracture of Shaft of Humerus
• Humerus Fracture

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2014-06-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2015-04-16
• Last updated: 2017-10-06

Locations

1 site across 1 country: Brazil