Thoracolumbar Burst Fracture Treated With Pedicle Screws: Radiographic Outcomes

NCT ID: NCT01979198

Last Updated: 2013-11-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-03-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

fusion group

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

No interventions assigned to this group

non-fusion group

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

No interventions assigned to this group

Eligibility Criteria

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.

• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

vghtpe user

Chief, Division of Spine Surgery, Dep. of Orthopedics and Traumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shih-Tien Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopedics and Traumatology, Taipei Veterans General Hospital

Locations

Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

2012-03-030BC

Identifier Type: -

Identifier Source: org_study_id