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

NCT01864785 | Unknown DMC

• 1 other identifier: xblzh2013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracolumbar Burst Fracture

Keywords

Operative treatment; internal fixation; posterior spinal fusion

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (3)

• failure of internal fixation

  3days after surgery

• failure of internal fixation

  3 months after surgery

• failure of internal fixation

  12 months after surgery

Study Arms (2)

Fixation Alone

OTHER

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

Procedure: Fixation Combined With Fusion

Fixation Combined With Fusion

OTHER

Posterior Fixation Combined With Articular Process Fusion in thoracolumbar Fracture.

Procedure: Fixation Alone

Interventions

Fixation Combined With Fusion PROCEDURE

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

Fixation Alone

Fixation Alone PROCEDURE

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

Fixation Combined With Fusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of thoracolumbar burst fracture

You may not qualify if:

• smoking during the period of the trial
• conservative treatment could be attempted
• do not meet the requirements of follow-up

Sponsors & Collaborators

• Jinling Hospital, China: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210002, China

RECRUITING

Related Publications (6)

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

  PMID: 23676860 RESULT

• 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.

  PMID: 23133723 RESULT

• 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.

  PMID: 22844053 RESULT

• 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.

  PMID: 22352229 RESULT

• 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.

  PMID: 22227107 RESULT

• 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.

  PMID: 21688000 RESULT

MeSH Terms

Interventions

Gene Fusion

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena

Study Officials

• Xu bin, master

  Jinling Hospital, China

  STUDY CHAIR

Central Study Contacts

xu bin, Master

CONTACT

13815863157

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Study Record Dates

• First Submitted: May 19, 2013
• First Posted: May 30, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 13, 2013

Record last verified: 2013-06

Locations

CN (1)