Analysis of correlation between the pedicular screw diameter to pedicle width ratio and the rate of fusion and surgery complications in Posterior Lumbar Interbody Fusion surgery
Analysis of correlation between the pedicular screw diameter to pedicle width ratio and the rate of fusion and surgery complications in Posterior Lumbar Interbody Fusion surgery
Design
A randomized, double-blind, controlled clinical trial
Settings and conduct
The study will be conducted as a blind clinical trial. The site of the study will be Imamreza Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Candidates to the spinal fixation surgery .Exclusion criteria:People with underlying diseases such as high blood pressure, diabetes and severe osteoporosis Patients with kidney failure Patients with metastases, tumor and scoliosis Overweight (BMI>30)
Intervention groups
Patients fall under the fusion with a pedicle screw of different sizes.The first fallopian of complications is 3 times and then 6 months after the surgery.
Main outcome variables
The pedicular screw diameter to pedicle width ratio, Mean volume of bleeding,Mean of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120527009878N17
Registration date:2023-07-25, 1402/05/03
Registration timing:prospective
Last update:2023-07-25, 1402/05/03
Update count:0
Registration date
2023-07-25, 1402/05/03
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
2023-08-11, 1402/05/20
Expected recruitment end date
2023-11-01, 1402/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analysis of correlation between the pedicular screw diameter to pedicle width ratio and the rate of fusion and surgery complications in Posterior Lumbar Interbody Fusion surgery
Public title
Correlation between the pedicular screw diameter to pedicle width ratio in Fusion surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates to the spinal fixation surgery
Agreed to participator
Exclusion criteria:
People with underlying diseases such as high blood pressure, diabetes and severe osteoporosis
Patients with kidney failure
Patients with metastases, tumor and scoliosis
Overweight (BMI>30)
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz Medical School
Street address
Floor 3, Center building N 2, Tabriz university of medical sciences, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5159115705
Approval date
2023-04-17, 1402/01/28
Ethics committee reference number
IR.TBZMED.REC.1402.055
Health conditions studied
1
Description of health condition studied
Spinal fusion
ICD-10 code
M99.3
ICD-10 code description
Osseous stenosis of neural canal
Primary outcomes
1
Description
The pedicular screw diameter to pedicle width ratio
Timepoint
During surgery
Method of measurement
Radiography
2
Description
Mean volume of bleeding
Timepoint
All the time of operation
Method of measurement
To measure the volume of suctioned blood and weigh the collected gauze from the field
Secondary outcomes
1
Description
Mean of pain
Timepoint
3 and 6 months after surgery
Method of measurement
Pain Visual Analog Questionnaire
2
Description
The amount of pseudoarthrosis
Timepoint
3 and 6 months after surgery
Method of measurement
Radiography
Intervention groups
1
Description
Intervention group:Patients fall under fusion with pedicle screws of different sizes and will be divided based on whether the pedicle screws occupy less than 50%, between 50% and 75%, and more than 75% of pedicle width,then the complications will be checked after 3 months and 6 months after surgery
Vice chancellor for research, ِDaneshgah street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Ghafar Sokouhi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 1334 0830
Email
shokouhigh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Moslem Shakeri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
shakerim@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Bishli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Neurosurgery ward, Emam Reza Hospital, Gholghasht Street, Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
beshali.iran@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
A portion of the data that represents the final outcome
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The data of this study will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
For modeling and guidance
From where data/document is obtainable
The person responsible for updating study information
What processes are involved for a request to access data/document
The applicant provides information about their application via email. Up to two weeks after the request, if accepted, documents or data files will be sent.