Status:
UNKNOWN
A Modified Placement of Two Additional Pedicle Screws at the Fracture Level for the Treatment of Thoracolumbar Burst Fractures--a Study Protocol of a Randomised Controlled Trial
Lead Sponsor:
Second Affiliated Hospital of Wenzhou Medical University
Conditions:
Posterior Short-segment Pedicle Instrumentation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Controversies exist about the best treatment of burst fractures of the thoracolumbar spine. Adding screws in fractured segment has been proved in many literatures that can improve construct stiffness ...
Detailed Description
A blinded randomised controlled trial (blinding for the patient and statistician, rather than for the clinician and researcher) will be conducted. A total of seventy patients with single thoracolumbar...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 18 years of age or above.
- single thoracolumbar burst fractures
- AO type A3 or A4 fractures
- Thoracolumbar Injury Classification and Severity Score (TLICS) of more than 4 and duration of \< 2 weeks
- application of posterior short-segment pedicle screws instrumentation at the fracture level Exclusion criteria
- 1\. previous pedicle instrumentation at the same level 2. multi-segmental thoracolumbar fractures or not AO type A3 or A4 are found 3. pregnancy 4. active infection or surgical site of the previous infection 5. planned emigration abroad within 2 years after inclusion 6. suffering from illness or long-term use of certain drugs affecting the stability of the spinal environment, such as metabolic bone disease, spinal tuberculosis and so on 7. the current use of anticoagulant (such as warfarin) or postoperative heparin for more than 6 months
Exclusion
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03384368
Start Date
December 1 2018
End Date
December 30 2019
Last Update
August 28 2018
Active Locations (1)
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1
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000