Posterior Fixation Alone Versus Posterior Fixation Combined With Articular Process Fusion in Thoracolumbar Burst Fractures
Sponsor study identifier
interventional
60
1 country
1
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
May 19, 2013
Actual (reported)May 30, 2013
Actual (reported)February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Cobb angle
Cobb angle is a variable for kyphotic deformity assessment
3 days after surgery.
Cobb angle
Cobb angle is a variable for kyphotic deformity assessment
3 months after surgery
Cobb angle
Cobb angle is a variable for kyphotic deformity assessment
12 months after surgery
Cobb angle
Cobb angle is a variable for kyphotic deformity assessment
18 months after surgery
failure of internal fixation
3days after surgery
failure of internal fixation
3 months after surgery
failure of internal fixation
12 months after surgery
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.
Articular process fusion with bone graft was carried out after screw fixation
Use the Posterior approach to achieve the reduction and stabilization by pedicle screw and rod alone
Jinling Hospital
Nanjing, Jiangsu, 210002, China
Ghobrial GM, Jallo J. Thoracolumbar spine trauma: review of the evidence. J Neurosurg Sci. 2013 Jun;57(2):115-22.
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.
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.
Xu bin, master
Jinling Hospital, China
First Submitted
May 19, 2013
First Posted
May 30, 2013
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2015
Estimated (date passed)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 13, 2013
Record last verified: 2013-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: