Evaluation of accuracy and cost-effectiveness of using surgical guidance system with the help of fluoroscopic images in placing pedicle screws in comparison with conventional methods
Determining the relationship of project variables in pedicle screw operation using navigation based on C-arm imaging in comparison with conventional free-hand surgery
Design
The study will be performed in two groups of control and intervention group as double blinded and randomized through random numbers using Excel. The sample size in this study is 44 patients.
Settings and conduct
This clinical trial project is being carried out using the C-Guide system, a product of Parsis Company and performed in Shariati Hospital.This study is double blinded in which patients and the person in charge of data analysis are not aware.In Parsis surgical guidance system, images are analyzed and calibration processes are performed. The doctor will then be able to see the direction of his instrument on the images.
Participants/Inclusion and exclusion criteria
The subjects are patients who have to undergo spine surgery and pedicle screw implantation in the neck, chest, lumbar and sacral surfaces.
Exclusion criteria are as follows: Dissatisfaction with participation in the study and age under 18 years
Intervention groups
There are patients who will have pedicle screw implantation using Surgical navigation or Fluoroscopy.
Main outcome variables
Method of intervention (embedding pedicle screws)
Duration of screw installation
Duration of operation
Received radiation
Total radiation time
Number of repeating radiolography
Number of drills
Investigation of the position of screws and the amount of cortical perforations and pedicle wall violatio by imaging
Duration of presence in the operating room
Setup time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210712051854N4
Registration date:2022-11-05, 1401/08/14
Registration timing:registered_while_recruiting
Last update:2022-11-05, 1401/08/14
Update count:0
Registration date
2022-11-05, 1401/08/14
Registrant information
Name
Mohammad Hossein Nabian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 1444
Email address
dr.nabian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of accuracy and cost-effectiveness of using surgical guidance system with the help of fluoroscopic images in placing pedicle screws in comparison with conventional methods
Public title
Evaluation of the effect of surgical guidance system in spine surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should have spinal surgery and a pedicle screw implanted in the neck surface.
Patients should have spinal surgery and a pedicle screw implanted in the chest surfaces.
Patients should have spinal surgery and pedicle screw implantation in the lumbar surfaces.
Patients should have spinal surgery and pedicle screw implantation at the sacral surfaces.
Exclusion criteria:
Dissatisfaction with participating in the study
Age under 18 years
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into control and intervention groups. The randomization of people will be done using the Permuted block randomization method with the random selection of the size of the blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
The blinding method in this study is double blinded in which patients and the person responsible for data analysis are not aware of the randomization setting of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town
City
Tehran
Province
Tehran
Postal code
1419943471
Approval date
2022-02-12, 1400/11/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1304
Health conditions studied
1
Description of health condition studied
Spine surgeries
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Screw insertion time
Timepoint
From the time of the start of the distal screw insertion until the end of it, during the operation
Method of measurement
Based on the time measured by the stopwatch
2
Description
Duration of operation
Timepoint
From the time of the first fluoroscopic image of the organ to the time of preparing the fluoroscopic image for the final check
Method of measurement
Based on the time measured by the stopwatch
3
Description
Radiation dose received
Timepoint
The amount of radiation received during the operation
Method of measurement
With the help of special radiology badges
4
Description
X-ray radiation time
Timepoint
The duration of taking pictures with the C arm in each of the imaging methods
Method of measurement
Using the device's own settings
5
Description
The number of repetitions of photography
Timepoint
The number of times of taking pictures with the arm in each of the imaging methods
Method of measurement
Using the device's own settings
6
Description
Duration of operating room stay
Timepoint
The duration of the patient's presence in the operation room from the time of entry to the time of exit
Method of measurement
Based on the time measured by the stopwatch
7
Description
Setup time
Timepoint
The time required to set up the operation equipment
Method of measurement
Based on the time measured by the stopwatch
Secondary outcomes
1
Description
Checking the alignment of screws by imaging
Timepoint
Checking the alignment of the distal screws with respect to the contour in the post-operative graph - the presence or absence of angulation and torsion
Method of measurement
Based on the opinion of an orthopedic and radiology specialist
Intervention groups
1
Description
Intervention group: There are patients who will have pedicle screw implantation using Surgical navigation or Fluoroscopy.
Category
Treatment - Other
2
Description
Control group: Includes patients in whom the placement of the pedicle screw will be determined using the conventional method (conventional C-arm).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Mohammad Hossein Nabian
Street address
North Kargar St., Jalal Al-Ahmad Three Ways, Opposite the Faculty of Economics, Dr. Shariati Research and Treatment Center
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
shariatihosp@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Parseh Intelligent Surgical Systems Co.
Full name of responsible person
Mustafa Abdul Ghafar
Street address
No. 8, Hamedan Aly, North Kargar St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1418693914
Phone
+98 21 4066 0365
Fax
+98 21 6612 4395
Email
contact@parsiss.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Parseh Intelligent Surgical Systems Co.
Proportion provided by this source
85
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
2
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Vice Chancellor for Research and Technology, Sixth Floor, Central Organization of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
15
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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Nabian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
mh-nabian@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Nabian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
mh-nabian@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Nabian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
mh-nabian@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Only part of the data such as information about the main outcome or the like can be shared.
When the data will become available and for how long
After printing the results as an article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For further research purposes and analysis
From where data/document is obtainable
In order to receive the data, it is necessary to refer to the scientific accountant or the corresponding author of the article
What processes are involved for a request to access data/document