The Effect of the Sagittal Insertion Angle of Pedicle Screws on Postoperative Thoracic Kyphosis in Adolescent Idiopathic Scoliosis
Design
A clinical trial with two groups of parallel, randomized intervention will be performed using random allocation software.
Settings and conduct
The angles of scoliosis, kyphosis, and vertebrae will be recorded, and patients will undergo posterior spinal fusion correction surgery with posterior spinal fusion using all-inclined and inclined pedicle screws. 1st, 12th, and 60th months in postoperative follow-up, scoliosis and kyphosis angles, and the vertebrae will be re-registered.
By comparing the two groups, the best angle of placement of the pedicular screws of the thoracic vertebrae, and its effect on the angle of the thoracic kyphosis after idiopathic correction surgery in adolescents will be determined.
Study place: Mofid and Taleghani Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with idiopathic adolescent scoliosis.
Exclusion criteria: Patients with neuromuscular and congenital scoliosis.
Intervention groups
1st intervention group: Patients will be operated on in the form of oblique pedicle screws
2nd intervention group: Patients will be operated on in the form of Parallel pedicle screws
Main outcome variables
Comparison of the effect of the sagittal Insertion angle of pedicle screws on postoperative Thoracic Kyphosis in adolescent idiopathic scoliosis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211218053441N1
Registration date:2022-02-06, 1400/11/17
Registration timing:retrospective
Last update:2022-02-06, 1400/11/17
Update count:0
Registration date
2022-02-06, 1400/11/17
Registrant information
Name
Mohsen Karami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2560
Email address
mkarami@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2016-03-22, 1395/01/03
Actual recruitment start date
2016-03-22, 1395/01/03
Actual recruitment end date
2016-03-22, 1395/01/03
Trial completion date
2017-12-20, 1396/09/29
Scientific title
The effect of the sagittal insertion angle of pedicle screws on postoperative thoracic kyphosis in adolescent idiopathic scoliosis.
Public title
The effect of the sagittal insertion angle of pedicle screws on postoperative thoracic kyphosis in adolescent idiopathic scoliosis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with idiopathic adolescent scoliosis
Exclusion criteria:
Patients with neuromuscular and congenital scoliosis.
Age
From 10 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
18
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization for 2 intervention groups. The randomization method will be done using software, 10 random numbers for each intervention group. The researcher can not play a role in predicting treatment of the disease, and choosing the type of surgery. Random sequence will generate by software. Group 1: 10 Cases and Group 2: 10 cases. Admitted patients will be placed in one of two groups according to the pre-determined code.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Institute for Children Health - Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Arabi st, Velenjak st, Tehran
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2021-12-20, 1400/09/29
Ethics committee reference number
IR.SBMU.RICH.REC.1400.057
Health conditions studied
1
Description of health condition studied
Adolescent Idiopathic Scoliosis
ICD-10 code
M41.1
ICD-10 code description
Juvenile and adolescent idiopathic scoliosis
Primary outcomes
1
Description
Comparison of the effect of the sagittal Insertion angle of pedicle screws on postoperative Thoracic Kyphosis in adolescent idiopathic scoliosis.
Timepoint
1st, 12th, and 60th months in postoperative follow-up.
Method of measurement
The measurement is done from x-ray by Surgimap software.
Secondary outcomes
1
Description
Comparison of the effect of the sagittal Insertion angle of pedicle screws on postoperativelumbar lordosis angle.
Timepoint
1st, 12th, and 60th months months in postoperative follow-up.
Method of measurement
The measurement is done from x-ray by Surgimap software.
2
Description
Comparison of the effect of the sagittal Insertion angle of pedicle screws on postoperative main Thoracic curve angle.
Timepoint
1st, 12th, and 60th months in postoperative follow-up.
Method of measurement
The measurement is done from x-ray by Surgimap software.
3
Description
Comparison of the effect of the sagittal Insertion angle of pedicle screws on postoperative main Cobb’s angles.
Timepoint
1st, 12th, and 60th months in postoperative follow-up.
Method of measurement
The measurement is done from x-ray by Surgimap software.
Intervention groups
1
Description
Intervention group: Patients will be operated on in the form of oblique pedicle screws
Category
Treatment - Surgery
2
Description
Intervention group: Intervention group: Patients will be operated on in the form of Parallel pedicle screws
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid children's Hospital
Full name of responsible person
ِDr Mohsen Karami
Street address
Shariati st
City
Tehran
Province
Tehran
Postal code
1551415468
Phone
+98 21 2222 7021
Fax
+98 21 2222 7021
Email
mn.karami@gmail.com
2
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr Mohsen Karami
Street address
Arabi st, Velenjak st
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2560
Email
mn.karami@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice Chancellor for research and technology, Shahid Beheshti University of Medical Sciences
Street address
Arabi st, Velenjak st
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Fax
+98 21 2243 9981
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for research and technology, Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mohsen Karami
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Spine surgery
Street address
Arabi st, Velenjak st, Tehran
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 2560
Fax
+98 21 2243 2560
Email
mn.karami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mohsen Karami
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
spine surgery
Street address
Arabi st, Velenjak st, Tehran
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 2560
Fax
+98 21 2243 2560
Email
mn.karami@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mohsen Karami
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
spine surgery
Street address
Arabi st, Velenjak st, Tehran
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 2560
Fax
+98 21 2243 2560
Email
mn.karami@gmail.com
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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data can be shared potentially after patients became unrecognizable.
When the data will become available and for how long
After completing the results and analyzing the data, access to them is allowed.
To whom data/document is available
This will be available for people working in academic institutions
Under which criteria data/document could be used
After obtaining written permission, the use of the data is permitted with reference to the source.
From where data/document is obtainable
Dr Mohsen Karami: mn.karami@gmail.com
What processes are involved for a request to access data/document
After completing the results and analyzing the data, the use of the data is allowed after the written request.