Clinical trial NCT01864785: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracolumbar Burst Fracture
Keywords: Operative treatment
internal fixation
posterior spinal fusion
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2013-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Cobb angle
timeFrame: 3 days after surgery.
measure: Cobb angle
timeFrame: 3 months after surgery
measure: Cobb angle
timeFrame: 12 months after surgery
measure: Cobb angle
timeFrame: 18 months after surgery
Secondary outcomes:
measure: failure of internal fixation
timeFrame: 3days after surgery
measure: failure of internal fixation
timeFrame: 3 months after surgery
measure: failure of internal fixation
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: NanJing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: Xu bin, master
role: STUDY_CHAIR
References:
citation: Ghobrial GM, Jallo J. Thoracolumbar spine trauma: review of the evidence. J Neurosurg Sci. 2013 Jun;57(2):115-22.
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.
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.
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.
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.
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.