Determining the long-term outcomes of the disease in patients with osteodiscitis without cage
Design
This study will be conducted without blinding and on 60 patients. in such a way that the patients will be randomly divided into two groups based on the indication of surgery and based on the randomization part of Excel. In this way, all the names are entered into Excel and we will create a random number in Excel using the Random Number Generation option in the toolback analysis section.
Settings and conduct
This study will be conducted without blinding and on 60 patients. This study will be performed in Al-Zahra Educational and Medical Center in 1401.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patient should have osteodiscitis according to the imaging findings. The patient is satisfied to participate in the study. Not addicted to drugs. Do not have autoimmune diseases and other diseases of the spinal cord and spine. Has not taken corticosteroids before or during treatment.
Exclusion criteria: lack of consent of the patient to participate in the study
Intervention groups
Cage placement is not performed in the intervention group. In the control group, Cage placement is used like the routine method.
Main outcome variables
Ability to walk
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220206053948N1
Registration date:2023-05-09, 1402/02/19
Registration timing:retrospective
Last update:2023-05-09, 1402/02/19
Update count:0
Registration date
2023-05-09, 1402/02/19
Registrant information
Name
Kiarash Farrahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0551 4677
Email address
k.fishi1991@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of long-term consequences of the disease in patients with osteodyscitis without correction
Public title
consequences of the disease in patients with osteodyscitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient should have osteodyscitis according to the expert's imaging findings.
The patient has the consent to participate in the study.
Do not have drug addiction.
Do not have autoimmune diseases and other diseases of the spinal cord and spine
Has not taken corticosteroids before or during treatment.
Exclusion criteria:
Lack of patient consent to enter the study
Age
From 15 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
the patients will be divided into two groups, case and control, based on the indication of surgery completely randomly and based on the randomization part of Excel. In this way, all the names are entered into Excel and we will create a random number in Excel using the Random Number Generation option in the Analysis ToolPak section.
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-12-25, 1400/10/04
Ethics committee reference number
IR.MUI.MED.REC.1400.711
Health conditions studied
1
Description of health condition studied
osteodyscitis
ICD-10 code
M46.2
ICD-10 code description
Osteomyelitis of vertebra
Primary outcomes
1
Description
Ability to walk
Timepoint
Before surgery and 1, 3, 6 and 12 months after surgery
Method of measurement
checklist and Standard questionnaire Japanese Orthopaedic Association on Low Back Pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cage Insertion is not performed. The patient is placed in the prone position and the vertebrae that have already been detected in the MRI are identified and photographed using the c_arm device.The desired place is cut or so-called stripped until the fast is released. After that, the lamina and spinous process of the inflamed vertebrae are removed.Then a path is found to access the disc between the infected vertebrae, the disc is removed and the inflamed parts are also removed (it has started to eat the body of the vertebra, which is called a corpectomy) and it is continued until the edge It starts to bleed and when it reaches this stage, Ben Chips (dead bone) is used and it is poured into the crushed space (between two vertebrae).After that, for the screws that we put, the appropriate part in terms of size and curvature is placed and fixed, and in order for the fusion (connection) to happen outside, Ben Chips is used again.Ben Chips is used in two parts, one for the fusion of broken air and one for the fusion of pedicles and screws at the end. Finally, a drain is used to remove secretions after the operation, and cage placement is not used in this method.
Category
Treatment - Devices
2
Description
Control group: Cage Insertion
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra Hospital
Full name of responsible person
Majid Rezvani
Street address
Al-Zahra Educational and Medical Center, Safa Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
alzahra.h@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavoosh
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
817467361
Phone
+98 31 3668 0048
Email
isfahanuni@med.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
10
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
Majid Rezvani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Al-Zahra Educational and Medical Center, Sofe Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
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
Majid Rezvani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Al-Zahra Educational and Medical Center, Sofe Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
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
Kiarash Farrahi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Al-Zahra Educational and Medical Center, Sofe Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
K.fishi1991@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
Undecided - It is not yet known if there will be 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