Clinical trial NCT02418260: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Fracture of Shaft of Humerus
Humerus Fracture
Keywords: Humerus
shaft
diaphyseal
fractures
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2015-04-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in the Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: 48 weeks
Secondary outcomes:
measure: Changes in the Visual Analog Scale for Pain (VAS)
timeFrame: 48 weeks
measure: Changes in the Constant-Murley Shoulder Outcome Score
timeFrame: 48 weeks
measure: Complications (nonunion, symptomatic malunion, hardware related issues, shoulder pain, infection, neurological injury and loss of range of motion of shoulder and/or elbow)
timeFrame: 48 weeks
measure: Radiographic angular deformity
timeFrame: at 48 weeks
measure: Time to previous activities return
timeFrame: 48 weeks
measure: Failure (need for aditional surgical procedure)
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hand and Upper Limb Surgery Discipline
Study officials:
affiliation: Federal University of São Paulo
name: Rafael Pierami
role: PRINCIPAL_INVESTIGATOR
References:
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