Evaluation of clinical outcome of long-segment fusion spine surgery in degenerative scoliosis
Design
The present study is a semi-experimental per & after intervention. Patients underwent Long Fusion surgery, and the results of these surgeries are reviewed and recorded in the preoperative, immediate, and 6 months after surgery.
Settings and conduct
Patients who have referred to the spinal subspecialty clinic of Al-Zahra Hospital in Isfahan due to degenerative scoliosis and are candidates for surgery according to the treating physician
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient with degenerative sclerosis Obtaining written consent to participate in the study
Exclusion criteria: No patient visits for follow-up sessions, Dissatisfaction to enter or continue studying, Severe and malignant osteoporosis, Severe obesity, Inadequate medical conditions, Age over 70 years
Intervention groups
Patients underwent long fusion surgery and the results of this operation are checked and recorded in the pre-surgical, immediately after surgery, 3 and 6 months after the surgery.
Main outcome variables
Doing or not doing decompression and the number of decompression and fusion levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200415047079N1
Registration date:2020-05-20, 1399/02/31
Registration timing:prospective
Last update:2020-05-20, 1399/02/31
Update count:0
Registration date
2020-05-20, 1399/02/31
Registrant information
Name
Soheil Fallahpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3624 7529
Email address
dr.sfallahpour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-30, 1399/03/10
Expected recruitment end date
2021-02-28, 1399/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clinical outcome of long-segment fusion spine surgery in degenerative scoliosis
Public title
clinical outcome of long-segment fusion spine surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with degenerative sclerosis
Obtaining written consent to participate in the study
Exclusion criteria:
No patient visits for follow-up sessions
Dissatisfaction to enter or continue studying
Severe and malignant osteoporosis
Severe obesity
Inadequate medical conditions
Age over 70 years
Age
To 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of esfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Hezar Jarib Street, Darvazeh-Shiraz Square
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-02-19, 1399/12/01
Ethics committee reference number
IR.MUI.MED.REC.1398.717
Health conditions studied
1
Description of health condition studied
Degenerative scoliosis
ICD-10 code
M41
ICD-10 code description
Scoliosis
Primary outcomes
1
Description
The severity of disability based on the ODI scale
Timepoint
In the preoperative period, immediately after surgery, 3 and 6 months after surgery are checked and recorded.
Method of measurement
Oswestry Disability Questionnaire (ODQ)
Secondary outcomes
empty
Intervention groups
1
Description
For patients with degenerative scoliosis, it is used in the long-segment fusion spine surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Subspecialty clinic of Al-Zahra Hospital in Isfahan
Full name of responsible person
Dr Soheil Fallahpour
Street address
Al-Zahra Medical and Educational Center, Al-Safa Boulevard,
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoe Javanmard
Street address
Isfahan University of Medical Sciences, Hezar Jarib St., Shiraz Gate,
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0048
Email
alzahra@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
1
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
Esfahan University of Medical Sciences
Full name of responsible person
Dr Majid Rezvani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Al-Zahra Educational and Medical Center, Al-Safa Boulevard,
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
m_rezvani@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Majid Rezvani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Al-Zahra Educational and Medical Center, Al-Safa Boulevard,
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
m_rezvani@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Soheil Fallahpour
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Al-Zahra Educational and Medical Center, Al-Safa Boulevard,
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
dr.sfallahpour@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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 part of the data such as information about the main consequence
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Researchers working in academic institutions
From where data/document is obtainable
dr.sfallahpour@gmail.com
What processes are involved for a request to access data/document