Surgical Interventions for the Treatment of Humeral Shaft Fractures

Phase 3

• Conditions: Humerus Fracture; Fracture of Shaft of Humerus

• Registration Number: NCT02418260
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-16
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-06
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to previous activities return	48 weeks	time to return to previous acitivities will bem described in weeks after the surgery
Changes in the Visual Analog Scale for Pain (VAS)	48 weeks	The VAS survey will be applied 1, 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)	48 weeks	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	at 48 weeks	Radiographic angular residual deformity will be measured at 48 weeks after the surgical procedure.
Failure (need for aditional surgical procedure)	48 weeks	Failure is described as need for aditional surgical procedure.
Changes in the Constant-Murley Shoulder Outcome Score	48 weeks	The Score will be obtained at 8, 24 and 48 weeks after the intervention

Trial Locations

Locations (1)

Hand and Upper Limb Surgery Discipline; 🇧🇷 Sao Paulo, Brazil