Comparison of the clinical outcome of decompressive laminectomy surgery with and without fusion in patients with lumbar spinal stenosis
Design
This study is a non-blinded clinical trial. The study population will be included all patients with lumbric canal stenosis refer to Imam Reza hospital of Kermanshah.126 eligible patients will be selected conveniently and randomly will be assigned to two intervention and control groups.
Settings and conduct
This study which will be conducted in Imam Reza hospital of Kermanshah city is non-blinded one. In this study, patients will be evaluated at the time of referring, 3 months and 9 months after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients suffering from lumbric canal stenosis that did not respond to medication
Intervention groups
In the intervention group, laminectomy surgery will be done with fusion. In the control group, a non-fusion laminectomy will be done
Main outcome variables
Patient's function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181122041726N1
Registration date:2018-12-23, 1397/10/02
Registration timing:prospective
Last update:2018-12-23, 1397/10/02
Update count:0
Registration date
2018-12-23, 1397/10/02
Registrant information
Name
Saeed Gharooee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3262 2396
Email address
saeedgharooee@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-01, 1397/10/11
Expected recruitment end date
2019-01-31, 1397/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study of the clinical outcome of decompressive laminectomy surgery with and without fusion in patients with lumbar spinal stenosis
Public title
study of the clinical outcome of decompressive laminectomy surgery with and without fusion in patients with spinal stenosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients suffering from lumbric canal stenosis that did not respond to medication
Exclusion criteria:
Infection
Congenital anomaly
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt. 126 similar cards will be provided which 63 of them are coded 1 which is indicative of the intervention group, and 63 of them are coded 2 which is indicative of the control group.Anyone who is eligible for inclusion in the study will selected one of these cards randomly (participants will not be aware of the type of intervention that they are assigned to).
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
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-09-27, 1396/07/05
Ethics committee reference number
ir.kums.rec.1396.351
Health conditions studied
1
Description of health condition studied
Spinal canal stenosis
ICD-10 code
M48.06
ICD-10 code description
Spinal stenosis, lumbar region
Primary outcomes
1
Description
Patient's function
Timepoint
At the beginning of the study, 3 and 9 months after surgery
Method of measurement
Oswestry Disability Index (ODI)
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
In the intervention group, laminectomy surgery will be done with fusion.
Category
Treatment - Surgery
2
Description
In the control group, a non-fusion laminectomy will be done
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Saeid Gharooee Ahangar
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Saied_gharooee@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Saeid Gharooee Ahangar
Position
Resident of Neurological Surgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Saied_gharooee@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Fatahian
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
rfatahian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Saeid Gharooee Ahangar
Position
Resident of Neurological Surgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Saied_gharooee@yahoo.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
Not applicable
Title and more details about the data/document
If requested, results will be made available to other academic researchers
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail