Surgical Interventions for the Treatment of Humeral Shaft Fractures

Federal University of São Paulo

Status and phase: Unknown; Phase 3

Conditions: Humerus Fracture; Fracture of Shaft of Humerus

Treatments: Procedure: Bridge Plate osteosynthesis; Procedure: Open reduction and plate osteosynthesis; Procedure: Locked intramedullary nail osteosynthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT02418260

24997313.8.0000.5505

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Open reduction and plate osteosynthesis

Active Comparator group

Description:

Open reduction and internal fixation with DCP 4.5mm plate.

Treatment:

Procedure: Open reduction and plate osteosynthesis

Bridge Plate

Experimental group

Description:

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

Treatment:

Procedure: Bridge Plate osteosynthesis

Intramedullary nail

Experimental group

Description:

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

Treatment:

Procedure: Locked intramedullary nail osteosynthesis