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

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ClinicalTrials.gov Identifier: NCT01864785
Recruitment Status : Unknown
Verified June 2013 by Zhonghua Ling, Jinling Hospital, China.
Recruitment status was:  Recruiting
First Posted : May 30, 2013
Last Update Posted : June 13, 2013
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Zhonghua Ling, Jinling Hospital, China

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Thoracolumbar Burst Fracture Procedure: Fixation Combined With Fusion Procedure: Fixation Alone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Posterior Fixation Alone Versus Posterior Fixation Combined With Articular Process Fusion in Thoracolumbar Burst Fractures
Study Start Date : February 2013
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Cobb angle [ Time Frame: 3 days after surgery. ]
    Cobb angle is a variable for kyphotic deformity assessment

  2. Cobb angle [ Time Frame: 3 months after surgery ]
    Cobb angle is a variable for kyphotic deformity assessment

  3. Cobb angle [ Time Frame: 12 months after surgery ]
    Cobb angle is a variable for kyphotic deformity assessment

  4. Cobb angle [ Time Frame: 18 months after surgery ]
    Cobb angle is a variable for kyphotic deformity assessment


Secondary Outcome Measures :
  1. failure of internal fixation [ Time Frame: 3days after surgery ]
  2. failure of internal fixation [ Time Frame: 3 months after surgery ]
  3. failure of internal fixation [ Time Frame: 12 months after surgery ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864785


Contacts
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Contact: xu bin, Master 13815863157

Locations
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China, Jiangsu
Jinling Hospital Recruiting
NanJing, Jiangsu, China, 210002
Contact: Xu Bin, master    13815863157    ling_zhonghua@163.com   
Sponsors and Collaborators
Jinling Hospital, China
National Natural Science Foundation of China
Investigators
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Study Chair: Xu bin, master Jinling Hospital, China

Publications of Results:
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Responsible Party: Zhonghua Ling, resident, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT01864785     History of Changes
Other Study ID Numbers: xblzh2013
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: June 13, 2013
Last Verified: June 2013
Keywords provided by Zhonghua Ling, Jinling Hospital, China:
Operative treatment
internal fixation
posterior spinal fusion
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries