Surgical Interventions for the Treatment of Humeral Shaft Fractures

Humerus Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02418260
• Other study ID #: 24997313.8.0000.5505
• Status: Recruiting
• Phase: Phase 3
• First received: April 8, 2015
• Last updated: October 4, 2017
• Start date: June 2014
• Est. completion date: June 2019

Study information

• Verified date: October 2017
• Source: Federal University of São Paulo
• Contact: Rafael Pierami, M.D.
• Phone: +5511982325308
• Email: rafael_pierami[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fracture of Shaft of Humerus
• Fractures, Bone
• Humeral Fractures
• Humerus Fracture

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Hand and Upper Limb Surgery Discipline	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (43)

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* Note: There are 43 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Changes in the Constant-Murley Shoulder Outcome Score	The Score will be obtained at 8, 24 and 48 weeks after the intervention	48 weeks
Secondary	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
Secondary	Radiographic angular deformity	Radiographic angular residual deformity will be measured at 48 weeks after the surgical procedure.	at 48 weeks
Secondary	Time to previous activities return	time to return to previous acitivities will bem described in weeks after the surgery	48 weeks
Secondary	Failure (need for aditional surgical procedure)	Failure is described as need for aditional surgical procedure.	48 weeks