Thoracolumbar Burst Fracture Treated With Pedicle Screws: Radiographic Outcomes

NCT ID: NCT01979198

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-03-31

Brief Summary

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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

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Conditions

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Burst Fracture

Keywords

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burst fracture, kyphotic angle, surgical outcome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

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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

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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vghtpe user

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shih-Tien Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopedics and Traumatology, Taipei Veterans General Hospital

Locations

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Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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2012-03-030BC

Identifier Type: -

Identifier Source: org_study_id