Comparison of Posterior Fixation Alone and Combined With Articular Process Fusion in Thoracolumbar Burst Fractures

Not Applicable

• Conditions: Thoracolumbar Burst Fracture
• Interventions: Procedure: Fixation Combined With Fusion; Procedure: Fixation Alone

• Registration Number: NCT01864785
• Lead Sponsor: Jinling Hospital, China

Brief Summary

Nearly 90% of all spinal fractures occur in the thoracolumbar region, and burst fractures are composed of 15% of such injuries. But the treatment of thoracolumbar fractures remains controversial. Treatment varies from the conservative management to various types of surgery. Internal fixation with spinal fusion is a surgical treatment method that is generally accepted for patients with thoracolumbar fracture. In this department, the investigators treat thoracolumbar burst fracture with posterior fixation alone and combined with articular process fusion. To evaluate the result of the two kinds of treatment, the investigators design this clinical trial. So, the investigators compared the radiological and clinical outcomes between patients who underwent posterior fixation alone and supplemented with fusion following the onset of thoracolumbar burst fractures.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-05-19
• Study First Submitted QC: 2013-05-24
• Study First Posted: 2013-05-30
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-12
• Last Update Posted: 2013-06-13
• Primary Completion: 2015-02
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Clinical diagnosis of thoracolumbar burst fracture

Exclusion Criteria

• smoking during the period of the trial
• conservative treatment could be attempted
• do not meet the requirements of follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixation Alone	Fixation Combined With Fusion	Use the Posterior approach to achieve the reduction and stabilization by pedicle screw and rod alone
Fixation Combined With Fusion	Fixation Alone	Posterior Fixation Combined With Articular Process Fusion in thoracolumbar Fracture.

Primary Outcome Measures

Name	Time	Method
Cobb angle	18 months after surgery	Cobb angle is a variable for kyphotic deformity assessment

Secondary Outcome Measures

Name	Time	Method
failure of internal fixation	12 months after surgery

Trial Locations

Locations (1)

Jinling Hospital; 🇨🇳 NanJing, Jiangsu, China