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

Primary Purpose

Thoracolumbar Burst Fracture

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fixation Combined With Fusion
Fixation Alone
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracolumbar Burst Fracture focused on measuring Operative treatment, internal fixation, posterior spinal fusion

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jinling HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Fixation Alone

Fixation Combined With Fusion

Arm Description

Use the Posterior approach to achieve the reduction and stabilization by pedicle screw and rod alone

Posterior Fixation Combined With Articular Process Fusion in thoracolumbar Fracture.

Outcomes

Primary Outcome Measures

Cobb angle
Cobb angle is a variable for kyphotic deformity assessment
Cobb angle
Cobb angle is a variable for kyphotic deformity assessment
Cobb angle
Cobb angle is a variable for kyphotic deformity assessment
Cobb angle
Cobb angle is a variable for kyphotic deformity assessment

Secondary Outcome Measures

failure of internal fixation
failure of internal fixation
failure of internal fixation

Full Information

First Posted
May 19, 2013
Last Updated
June 12, 2013
Sponsor
Jinling Hospital, China
Collaborators
National Natural Science Foundation of China
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1. Study Identification

Unique Protocol Identification Number
NCT01864785
Brief Title
Comparison of Posterior Fixation Alone and Combined With Articular Process Fusion in Thoracolumbar Burst Fractures
Official Title
Posterior Fixation Alone Versus Posterior Fixation Combined With Articular Process Fusion in Thoracolumbar Burst Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
Collaborators
National Natural Science Foundation of China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracolumbar Burst Fracture
Keywords
Operative treatment, internal fixation, posterior spinal fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fixation Alone
Arm Type
Other
Arm Description
Use the Posterior approach to achieve the reduction and stabilization by pedicle screw and rod alone
Arm Title
Fixation Combined With Fusion
Arm Type
Other
Arm Description
Posterior Fixation Combined With Articular Process Fusion in thoracolumbar Fracture.
Intervention Type
Procedure
Intervention Name(s)
Fixation Combined With Fusion
Intervention Description
Articular process fusion with bone graft was carried out after screw fixation
Intervention Type
Procedure
Intervention Name(s)
Fixation Alone
Intervention Description
Use the Posterior approach to achieve the reduction and stabilization by pedicle screw and rod alone
Primary Outcome Measure Information:
Title
Cobb angle
Description
Cobb angle is a variable for kyphotic deformity assessment
Time Frame
3 days after surgery.
Title
Cobb angle
Description
Cobb angle is a variable for kyphotic deformity assessment
Time Frame
3 months after surgery
Title
Cobb angle
Description
Cobb angle is a variable for kyphotic deformity assessment
Time Frame
12 months after surgery
Title
Cobb angle
Description
Cobb angle is a variable for kyphotic deformity assessment
Time Frame
18 months after surgery
Secondary Outcome Measure Information:
Title
failure of internal fixation
Time Frame
3days after surgery
Title
failure of internal fixation
Time Frame
3 months after surgery
Title
failure of internal fixation
Time Frame
12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xu bin, Master
Phone
13815863157
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu bin, master
Organizational Affiliation
Jinling Hospital, China
Official's Role
Study Chair
Facility Information:
Facility Name
Jinling Hospital
City
NanJing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu Bin, master
Phone
13815863157
Email
ling_zhonghua@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
23676860
Citation
Ghobrial GM, Jallo J. Thoracolumbar spine trauma: review of the evidence. J Neurosurg Sci. 2013 Jun;57(2):115-22.
Results Reference
result
PubMed Identifier
23133723
Citation
Hwang JU, Hur JW, Lee JW, Kwon KY, Lee HK. Comparison of posterior fixation alone and supplementation with posterolateral fusion in thoracolumbar burst fractures. J Korean Neurosurg Soc. 2012 Oct;52(4):346-52. doi: 10.3340/jkns.2012.52.4.346. Epub 2012 Oct 22.
Results Reference
result
PubMed Identifier
22844053
Citation
Jindal N, Sankhala SS, Bachhal V. The role of fusion in the management of burst fractures of the thoracolumbar spine treated by short segment pedicle screw fixation: a prospective randomised trial. J Bone Joint Surg Br. 2012 Aug;94(8):1101-6. doi: 10.1302/0301-620X.94B8.28311.
Results Reference
result
PubMed Identifier
22352229
Citation
Islam MA, Sakeb N, Islam A, Sarker SK, Mondol SK. Evaluation of the results of posterior decompression, posterolateral fusion and stabilization by pedicle screw and rod in traumatic thoracolumbar fractures. Bangladesh Med Res Counc Bull. 2011 Dec;37(3):97-101. doi: 10.3329/bmrcb.v37i3.9121.
Results Reference
result
PubMed Identifier
22227107
Citation
Schmid R, Lindtner RA, Lill M, Blauth M, Krappinger D, Kammerlander C. Combined posteroanterior fusion versus transforaminal lumbar interbody fusion (TLIF) in thoracolumbar burst fractures. Injury. 2012 Apr;43(4):475-9. doi: 10.1016/j.injury.2011.12.011. Epub 2012 Jan 9.
Results Reference
result
PubMed Identifier
21688000
Citation
Ge CM, Wang YR, Jiang SD, Jiang LS. Thoracolumbar burst fractures with a neurological deficit treated with posterior decompression and interlaminar fusion. Eur Spine J. 2011 Dec;20(12):2195-201. doi: 10.1007/s00586-011-1875-6. Epub 2011 Jun 18.
Results Reference
result

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

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