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

NCT ID: NCT01864785

Last Updated: 2013-06-13

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Thoracolumbar Burst Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fixation Alone

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

Group Type OTHER

Fixation Combined With Fusion

Intervention Type PROCEDURE

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.

Group Type OTHER

Fixation Alone

Intervention Type PROCEDURE

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

Interventions

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Fixation Combined With Fusion

Articular process fusion with bone graft was carried out after screw fixation

Intervention Type PROCEDURE

Fixation Alone

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Jinling Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Zhonghua Ling

resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xu bin, master

Role: STUDY_CHAIR

Jinling Hospital, China

Locations

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Jinling Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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xu bin, Master

Role: CONTACT

13815863157

Facility Contacts

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Xu Bin, master

Role: primary

13815863157

References

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Ghobrial GM, Jallo J. Thoracolumbar spine trauma: review of the evidence. J Neurosurg Sci. 2013 Jun;57(2):115-22.

Reference Type RESULT
PMID: 23676860 (View on PubMed)

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.

Reference Type RESULT
PMID: 23133723 (View on PubMed)

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.

Reference Type RESULT
PMID: 22844053 (View on PubMed)

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.

Reference Type RESULT
PMID: 22352229 (View on PubMed)

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.

Reference Type RESULT
PMID: 22227107 (View on PubMed)

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.

Reference Type RESULT
PMID: 21688000 (View on PubMed)

Other Identifiers

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xblzh2013

Identifier Type: -

Identifier Source: org_study_id

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