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

Study Overview
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Brief Summary
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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.

Official Title
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Posterior Fixation Alone Versus Posterior Fixation Combined With Articular Process Fusion in Thoracolumbar Burst Fractures

Conditions
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Thoracolumbar Burst Fracture

Intervention / Treatment
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* Procedure: Fixation Combined With Fusion
* Procedure: Fixation Alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fixation Alone<br>Use the Posterior approach to achieve the reduction and stabilization by pedicle screw and rod alone | Procedure: Fixation Combined With Fusion<br>* Articular process fusion with bone graft was carried out after screw fixation<br>|
| Other: Fixation Combined With Fusion<br>Posterior Fixation Combined With Articular Process Fusion in thoracolumbar Fracture. | Procedure: Fixation Alone<br>* Use the Posterior approach to achieve the reduction and stabilization by pedicle screw and rod alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cobb angle | Cobb angle is a variable for kyphotic deformity assessment | 3 days after surgery. | 
| Cobb angle | Cobb angle is a variable for kyphotic deformity assessment | 3 months after surgery | 
| Cobb angle | Cobb angle is a variable for kyphotic deformity assessment | 12 months after surgery | 
| Cobb angle | Cobb angle is a variable for kyphotic deformity assessment | 18 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failure of internal fixation |  | 3days after surgery | 
| failure of internal fixation |  | 3 months after surgery | 
| failure of internal fixation |  | 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Operative treatment, internal fixation, posterior spinal fusion