Thoracolumbar Burst FractureNCT01864785
Comparison of Posterior Fixation Alone and Combined With Articular Process Fusion in Thoracolumbar Burst Fractures
A study testing Fixation Combined With Fusion and Fixation Alone in people with Thoracolumbar Burst Fracture, run by Jinling Hospital, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thoracolumbar Burst Fracture
- What is being tested?
- Fixation Combined With Fusion and Fixation Alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of thoracolumbar burst fracture
Who cannot join
- smoking during the period of the trial
- conservative treatment could be attempted
- do not meet the requirements of follow-up
Trial locations and contacts
1 site in 1 country.
xu bin, Master contact
China1 site, 1 recruiting
- Recruiting
Jinling Hospital
Nanjing, Jiangsu, 210002
Xu Bin, master, 13815863157, ling_zhonghua@163.com
About this study
Official title: Posterior Fixation Alone Versus Posterior Fixation Combined With Articular Process Fusion in Thoracolumbar Burst Fractures
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
- Being tested
- Fixation Combined With Fusion, Fixation Alone
- Keywords
- Operative treatment, internal fixation, posterior spinal fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixation Combined With FusionProcedure or surgery
Articular process fusion with bone graft was carried out after screw fixation
Fixation AloneProcedure or surgery
Use the Posterior approach to achieve the reduction and stabilization by pedicle screw and rod alone
| Study group | Role | What they receive |
|---|---|---|
| Fixation Alone | Other | Use the Posterior approach to achieve the reduction and stabilization by pedicle screw and rod alone Receives: Procedure: Fixation Combined With Fusion |
| Fixation Combined With Fusion | Other | Posterior Fixation Combined With Articular Process Fusion in thoracolumbar Fracture. Receives: Procedure: Fixation Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb angle
Cobb angle is a variable for kyphotic deformity assessment
Measured: 3 days after surgery.
Cobb angle
Cobb angle is a variable for kyphotic deformity assessment
Measured: 3 months after surgery
Cobb angle
Cobb angle is a variable for kyphotic deformity assessment
Measured: 12 months after surgery
Cobb angle
Cobb angle is a variable for kyphotic deformity assessment
Measured: 18 months after surgery
Secondary outcomes (3)
failure of internal fixation
Measured: 3days after surgery
failure of internal fixation
Measured: 3 months after surgery
failure of internal fixation
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Thoracolumbar Burst FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Zhonghua Ling, Jinling Hospital, China
- Investigators
- Xu bin, master, Study chair, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864785
- Sponsor's protocol ID
- xblzh2013
- Status last verified
- Jun 2013
- First submitted
- 19 May 2013
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ghobrial GM, Jallo J. Thoracolumbar spine trauma: review of the evidence. J Neurosurg Sci. 2013 Jun;57(2):115-22.
PubMed 23676860Hwang 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.
PubMed 23133723Jindal 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.
PubMed 22844053Islam 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.
PubMed 22352229Schmid 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.
PubMed 22227107Ge 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.
PubMed 21688000
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Fixation Alone Versus Posterior Fixation Combined With Articular Process Fusion in Thoracolumbar Burst Fractures
- ClinicalTrials.gov ID
- NCT01864785
- Acronym / sponsor ID
- xblzh2013
- Conditions
- Thoracolumbar Burst Fracture
- Keywords
- Operative treatment, internal fixation, posterior spinal fusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Feb 2013
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 30 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixation Alone | Other | Procedure: Fixation Combined With FusionUse the Posterior approach to achieve the reduction and stabilization by pedicle screw and rod alone |
| Fixation Combined With Fusion | Other | Procedure: Fixation AlonePosterior Fixation Combined With Articular Process Fusion in thoracolumbar Fracture. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of thoracolumbar burst fracture
Key exclusion criteria (3 listed)
- smoking during the period of the trial
- conservative treatment could be attempted
- do not meet the requirements of follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixation Combined With FusionArticular process fusion with bone graft was carried out after screw fixation | Procedure or surgery | Fixation Alone |
| Fixation AloneUse the Posterior approach to achieve the reduction and stabilization by pedicle screw and rod alone | Procedure or surgery | Fixation Combined With Fusion |
Primary outcome
Cobb angle
Time frame: 3 days after surgery.
Cobb angle is a variable for kyphotic deformity assessment
Cobb angle
Time frame: 3 months after surgery
Cobb angle is a variable for kyphotic deformity assessment
Cobb angle
Time frame: 12 months after surgery
Cobb angle is a variable for kyphotic deformity assessment
Cobb angle
Time frame: 18 months after surgery
Cobb angle is a variable for kyphotic deformity assessment
3 secondary outcomes
failure of internal fixation
Time frame: 3days after surgery
failure of internal fixation
Time frame: 3 months after surgery
failure of internal fixation
Time frame: 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2013.
- Results publication: PubMed 23676860Ghobrial GM, Jallo J. Thoracolumbar spine trauma: review of the evidence. J Neurosurg Sci. 2013 Jun;57(2):115-22.
- Results publication: PubMed 23133723Hwang 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.
- Results publication: PubMed 22844053Jindal 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.
- Results publication: PubMed 22352229Islam 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.
- Results publication: PubMed 22227107Schmid 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.
- Results publication: PubMed 21688000Ge 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xu bin, Master contact
Xu bin, master study chair
Jinling Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixation Combined With Fusion and Fixation Alone in people with Thoracolumbar Burst Fracture, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xu bin, Master (13815863157), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb angle (time frame: 3 days after surgery.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01864785, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2013.