The effect of rod contouring on the normal lumbar spine curvature in the one level fusion
Design
Patients undergoing surgery will be divided into three random groups using the www.random.org by the Gaussian Generator order.
After random assignment of the study groups, the A, B 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.
Settings and conduct
Imam Reza Hospital
Participants/Inclusion and exclusion criteria
inclusion criteriaTraumatic fractures of type of compression, sprain and fracture due to spinal flexure
Which require surgery
Severe spinal canal stenosis
Completion of 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
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 effected by autograft, which will be made from the vagus and laminae of the vertebrae. In this case The stage of action will end upon radical curvature
Intervention group (B): 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 autograft, which will be obtained from the lobe and the lamina of the vertebrae. Rads will not be entered
Main outcome variables
vertebral fusion
At the beginning of the study, 6 months after the intervention
Using radiological evaluations and physical examination using visual analogue scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120527009878N9
Registration date:2019-07-05, 1398/04/14
Registration timing:registered_while_recruiting
Last update:2019-07-05, 1398/04/14
Update count:0
Registration date
2019-07-05, 1398/04/14
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
2019-03-06, 1397/12/15
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of rod contouring on the normal lumbar spine curvature in the one level fusion.
Public title
Study the effect of curvature on the spinal cord in maintaining normal curvature of the spine
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Lumbar lordosis approval using graph
Complaint of lumbar lordosis caused by lumbar pain
Exclusion criteria:
Pain caused by radiculopathy
Having a kayape
History of surgery on the spine
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
54
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients undergoing surgery will be divided into two random groups using the www.random.org
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
tabriz hotel marmar
City
tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.TBZMED.REC.1397.1098
Health conditions studied
1
Description of health condition studied
spinal fractures and spinal canal stenosis
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: 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
ntervention 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.