Thoracolumbar Burst Fracture Treated With Pedicle Screws: Radiographic Outcomes

Completed

• Conditions: Burst Fracture

• Registration Number: NCT01979198
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

The surgical results of thoracolumbar and lumbar burst fracture have been reported to be comparable between patients with and without fusion in a midterm follow-up. There is, however, no report comparing the results of fusion and non-fusion with a long-term follow-up. Therefore, a long term comparative study is still needed to focus on the issues of functional and radiographic outcomes, especially preservation of the motion segment in the long run, to determine whether fusion should be a routine procedure for surgically treated burst fractures of the thoracolumbar and lumbar spines. Therefore, we report herein a long-term comparative study of fusion and non-fusion based on our previous work, with an average 134 months of follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-10
• Study First Submitted: 2013-10-16
• Study First Submitted QC: 2013-10-31
• Last Update Submitted: 2013-10-31
• Study First Posted: 2013-11-08
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• neurologically intact spine with a kyphotic angle more than 20o, decreased vertebral body height more than 50% or a canal compromise more than 50%;
• incomplete neurological deficit with a canal compromise less than 50%;
• complete neurological deficit;
• multilevel spinal injury or multiple trauma.

Exclusion Criteria

• progression of the neurological deficit;
• a canal compromise still more than 50% in those who showed no improvement of the neurological deficit.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiologic outcomes	up to postoperative 161 months	* Injured vertebral body height; * Kyphotic angle; * Regional segmental motion

Secondary Outcome Measures

Name	Time	Method
Functional outcomes	up to postoperative 161 months	* Greenough Low Back Outcome Scale; * Visual Analogue Scale (VAS) for back pain; * Neurologic status: Frankel grading system

Trial Locations

Locations (1)

Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan