Skip to main content
OpenTrials
Completed

NCT Number: NCT01979198

Thoracolumbar Burst Fracture Treated With Pedicle Screws: Radiographic Outcomes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Burst Fracture

Age range

Up to 60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital

Taipei, 112, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Radiologic outcomes

    Time frame: postoperative 6 weeks

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

  2. Radiologic outcomes

    Time frame: postoperative 12 weeks

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

  3. Radiologic outcomes

    Time frame: postoperative 6 months

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

  4. Radiologic outcomes

    Time frame: postoperative 12 months

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

  5. Radiologic outcomes

    Time frame: postoperative 24 months

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

  6. Radiologic outcomes

    Time frame: up to postoperative 161 months

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

Secondary outcomes

  1. Functional outcomes

    Time frame: postoperative 24 months

    • Greenough Low Back Outcome Scale
    • Visual Analogue Scale (VAS) for back pain
    • Neurologic status: Frankel grading system

  2. Functional outcomes

    Time frame: up to postoperative 161 months

    • Greenough Low Back Outcome Scale
    • Visual Analogue Scale (VAS) for back pain
    • Neurologic status: Frankel grading system

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study title

Thoracolumbar Burst Fracture Treated With Pedicle Screws: Radiographic Analysis of Discs and Vertebral Body Height at Fractured and Adjacent Levels

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 8, 2013
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.