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

Jinling Hospital, China

Status: Unknown

Conditions: Thoracolumbar Burst Fracture

Treatments: Procedure: Fixation Alone; Procedure: Fixation Combined With Fusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01864785

xblzh2013

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Fixation Alone

Other group

Description:

Use the Posterior approach to achieve the reduction and stabilization by pedicle screw and rod alone

Treatment:

Procedure: Fixation Combined With Fusion

Fixation Combined With Fusion

Other group

Description:

Posterior Fixation Combined With Articular Process Fusion in thoracolumbar Fracture.

Treatment:

Procedure: Fixation Alone