Evaluation of the effect of Cross-linkage between pedicular screws for fusion in patient with traumatic thoracolumbar vertebral fractures
Design
The study is a randomized, community-based, and pragmatic clinical trial consisting of 60 patients in 3 parallel groups with double-blind design.
Settings and conduct
This study was performed on 60 patients with thoracolumbar vertebral fractures due to spinal cord trauma referring to Tabriz Imam Hospital. All patients received initial neurological evaluation of trauma and medical emergencies through a complete neurological examination. Thoracolumbar spine radiography and CT scan was performed by triple reconstruction in axillary and sagittal and coronal segments and MRI was performed in the axillary and sagital segments after admission.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) Spinal fracture based on Denis model except fractures-deformity fractures, 2) TLCS score above 4, 3) Completion of informed consent form
Exit criteria: 1) Pathological fracture 2) Multiple vertebral fractures 3) Synchronous head trauma 4) Neurological defects before fracture 5) Non-neurological examinations 6. Fracture-fracture fractures
Intervention groups
Control group (A): After the patient's preparation, fixation and posterior fusion will be done using a pedicure screw. After the rod is inserted, the fusion will be done by autograft, which is obtained from the caryophylline and laminae of the vertebrae. In this group, the intervention will end at this stage.
Intervention group (B): A cross-link will be embedded in the middle of the structure and instrumentation process will be terminated.
Intervention group (C): Two cross-links, one at the lower end and one at the upper end of the structure, and the instrumentation process will be terminated.
Main outcome variables
Bone fusion rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120527009878N3
Registration date:2018-09-13, 1397/06/22
Registration timing:retrospective
Last update:2018-09-13, 1397/06/22
Update count:0
Registration date
2018-09-13, 1397/06/22
Registrant information
Name
Firooz Salehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 0830
Email address
salehpourf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Cross-linkage between pedicular screws for fusion in patient with traumatic thoracolumbar vertebral fractures
Public title
The effect of using interface between right and left screws on bone formation around broken vertebrae
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Traumatic fractures of type of compression, sprain and fracture due to spinal flexure
Thoracolumbar Injury Classification and Severity Score (TILCS) more than 4
Completing the informed consent form
Exclusion criteria:
Traumatic fractures of type of fracture-in-depression
Pathological fractures
Fracture in several vertebrae
Head trauma simultaneous with vertebral fracture
A neurological condition in which neurological examination is not possible for the patient at the time of admission
Having a nerve defect before the spinal trauma
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients undergoing surgery will be divided into three random groups using the www.random.org by the Gaussian Generator order.
Blinding (investigator's opinion)
Double blinded
Blinding description
After random assignment of the study groups, the A, B and C labels were assigned to the target group by the secretary. Then, the patients will be intervened by the researcher in the operating room in the case group. All persons involved in the study will be unaware of the type of intervention performed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Science
Street address
Tabriz University of Medical Science , Gholghasht street , Azadi street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2018-08-06, 1397/05/15
Ethics committee reference number
IR.TBZMED.REC.1397.390
Health conditions studied
1
Description of health condition studied
Traumatic thoracolumbar vertebral fractures
ICD-10 code
S32.0
ICD-10 code description
Fracture of lumbar vertebra
Primary outcomes
1
Description
Lumbar vertebral fusion
Timepoint
At the beginning of the study, 6 months after the intervention
Method of measurement
Using radiological evaluations and physical examination using visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group (A): After the patient's preparation, fixation and posterior fusion will be done using a pedicure screw and the rod will inserted. Then the fusion will be effected by the otograft, which is obtained from the spinous process and the lamina of the vertebrae, and at this stage the action will be terminated.
Category
Treatment - Surgery
2
Description
Intervention group (B): After preparing the patient, fixation and posterior fusion are completed using a pedicle and after the installation of the Rod, the fusion will be effected by the otograft, which is obtained from the spinous process and the lamina of the vertebrae. Then a cross link is placed in the central part of the structure and the instrumentation process will end.
Category
Treatment - Surgery
3
Description
Intervention group (C): After the patient's preparation, fixation and posterior fusion will be done using a pedicure screw. After the rod is inserted, the fusion will be effected by otograft, which is obtained from the spinous process and the lamina of the vertebrae. Then, two cross-links, one at the lower end and one at the upper end of the structure, will be completed and the instrumentation process will be completed.