Comparison of Posterior Fixation Alone and Combined With Articular Process Fusion in Thoracolumbar Burst Fractures

June 12, 2013 updated by: Zhonghua Ling, Jinling Hospital, China

Posterior Fixation Alone Versus Posterior Fixation Combined With Articular Process Fusion in Thoracolumbar Burst Fractures

Nearly 90% of all spinal fractures occur in the thoracolumbar region, and burst fractures are composed of 15% of such injuries. But the treatment of thoracolumbar fractures remains controversial. Treatment varies from the conservative management to various types of surgery. Internal fixation with spinal fusion is a surgical treatment method that is generally accepted for patients with thoracolumbar fracture. In this department, the investigators treat thoracolumbar burst fracture with posterior fixation alone and combined with articular process fusion. To evaluate the result of the two kinds of treatment, the investigators design this clinical trial. So, the investigators compared the radiological and clinical outcomes between patients who underwent posterior fixation alone and supplemented with fusion following the onset of thoracolumbar burst fractures.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • NanJing, Jiangsu, China, 210002
        • Recruiting
        • Jinling Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of thoracolumbar burst fracture

Exclusion Criteria:

  • smoking during the period of the trial
  • conservative treatment could be attempted
  • do not meet the requirements of follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Fixation Alone
Use the Posterior approach to achieve the reduction and stabilization by pedicle screw and rod alone
Procedure: Fixation Combined With Fusion
Articular process fusion with bone graft was carried out after screw fixation
OTHER: Fixation Combined With Fusion
Posterior Fixation Combined With Articular Process Fusion in thoracolumbar Fracture.
Procedure: Fixation Alone
Use the Posterior approach to achieve the reduction and stabilization by pedicle screw and rod alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cobb angle
Time Frame: 3 days after surgery.
Cobb angle is a variable for kyphotic deformity assessment
3 days after surgery.
Cobb angle
Time Frame: 3 months after surgery
Cobb angle is a variable for kyphotic deformity assessment
3 months after surgery
Cobb angle
Time Frame: 12 months after surgery
Cobb angle is a variable for kyphotic deformity assessment
12 months after surgery
Cobb angle
Time Frame: 18 months after surgery
Cobb angle is a variable for kyphotic deformity assessment
18 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
failure of internal fixation
Time Frame: 3days after surgery
3days after surgery
failure of internal fixation
Time Frame: 3 months after surgery
3 months after surgery
failure of internal fixation
Time Frame: 12 months after surgery
12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Collaborators

National Natural Science Foundation of China

Investigators

  • Study Chair: Xu bin, master, Jinling Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ANTICIPATED)

February 1, 2015

Study Completion (ANTICIPATED)

February 1, 2015

Study Registration Dates

First Submitted

May 19, 2013

First Submitted That Met QC Criteria

May 24, 2013

First Posted (ESTIMATE)

May 30, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 13, 2013

Last Update Submitted That Met QC Criteria

June 12, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xblzh2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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