Thoracolumbar Burst Fracture Treated With Pedicle Screws: Radiographic Outcomes

NCT01979198 | Completed DMC

• 1 other identifier: 2012-03-030BC
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Burst Fracture

Keywords

burst fracture, kyphotic angle, surgical outcome

Outcome Measures

Primary Outcomes (6)

• Radiologic outcomes

  * Injured vertebral body height * Kyphotic angle * Regional segmental motion

  postoperative 6 weeks

• Radiologic outcomes

  * Injured vertebral body height * Kyphotic angle * Regional segmental motion

  postoperative 12 weeks

• Radiologic outcomes

  * Injured vertebral body height * Kyphotic angle * Regional segmental motion

  postoperative 6 months

• Radiologic outcomes

  * Injured vertebral body height * Kyphotic angle * Regional segmental motion

  postoperative 12 months

• Radiologic outcomes

  * Injured vertebral body height * Kyphotic angle * Regional segmental motion

  postoperative 24 months

• Radiologic outcomes

  * Injured vertebral body height * Kyphotic angle * Regional segmental motion

  up to postoperative 161 months

Secondary Outcomes (2)

• Functional outcomes

  postoperative 24 months

• Functional outcomes

  up to postoperative 161 months

Study Arms (2)

fusion group

close reduction with posterior short-segment transpedicular screw fixation with posterior fusion

non-fusion group

close reduction with posterior short-segment transpedicular screw fixation without posterior fusion

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients suffered from burst fracture of the thoracolumbar and lumbar spine

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Study Officials

• Shih-Tien Wang, MD

  Department of Orthopedics and Traumatology, Taipei Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Spine Surgery, Dep. of Orthopedics and Traumatology

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: November 8, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 8, 2013

Record last verified: 2013-10

Locations

TW (1)