Thoracolumbar Burst Fracture Treated With Pedicle Screws: Radiographic Outcomes

Burst Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01979198
• Other study ID #: 2012-03-030BC
• Status: Completed
• Phase: N/A
• First received: October 16, 2013
• Last updated: October 31, 2013
• Start date: December 2012
• Est. completion date: March 2013

Study information

• Verified date: October 2013
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 60 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Burst Fracture
• Fractures, Bone

Locations

Country	Name	City	State
Taiwan	Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiologic outcomes	Injured vertebral body height; Kyphotic angle; Regional segmental motion	postoperative 6 weeks	No
Primary	Radiologic outcomes	Injured vertebral body height; Kyphotic angle; Regional segmental motion	postoperative 12 weeks	No
Primary	Radiologic outcomes	Injured vertebral body height; Kyphotic angle; Regional segmental motion	postoperative 6 months	No
Primary	Radiologic outcomes	Injured vertebral body height; Kyphotic angle; Regional segmental motion	postoperative 12 months	No
Primary	Radiologic outcomes	Injured vertebral body height; Kyphotic angle; Regional segmental motion	postoperative 24 months	No
Primary	Radiologic outcomes	Injured vertebral body height; Kyphotic angle; Regional segmental motion	up to postoperative 161 months	No
Secondary	Functional outcomes	Greenough Low Back Outcome Scale; Visual Analogue Scale (VAS) for back pain; Neurologic status: Frankel grading system	postoperative 24 months	No
Secondary	Functional outcomes	Greenough Low Back Outcome Scale; Visual Analogue Scale (VAS) for back pain; Neurologic status: Frankel grading system	up to postoperative 161 months	No