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

Thoracolumbar Burst Fracture Clinical Trial

Official title:

Posterior Fixation Alone Versus Posterior Fixation Combined With Articular Process Fusion in Thoracolumbar Burst Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01864785
• Other study ID #: xblzh2013
• Status: Recruiting
• Phase: N/A
• First received: May 19, 2013
• Last updated: June 12, 2013
• Start date: February 2013
• Est. completion date: February 2015

Study information

• Verified date: June 2013
• Source: Jinling Hospital, China
• Contact: xu bin, Master
• Phone: 13815863157
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Thoracolumbar Burst Fracture

Intervention

Procedure:
• Fixation Combined With Fusion
Articular process fusion with bone graft was carried out after screw fixation
• Fixation Alone
Use the Posterior approach to achieve the reduction and stabilization by pedicle screw and rod alone

Locations

Country	Name	City	State
China	Jinling Hospital	NanJing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jinling Hospital, China	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cobb angle	Cobb angle is a variable for kyphotic deformity assessment	3 days after surgery.	No
Primary	Cobb angle	Cobb angle is a variable for kyphotic deformity assessment	3 months after surgery	No
Primary	Cobb angle	Cobb angle is a variable for kyphotic deformity assessment	12 months after surgery	No
Primary	Cobb angle	Cobb angle is a variable for kyphotic deformity assessment	18 months after surgery	No
Secondary	failure of internal fixation		3days after surgery	No
Secondary	failure of internal fixation		3 months after surgery	No
Secondary	failure of internal fixation		12 months after surgery	No