Clinical findings of patients with osteodiscitis with spinal instability without cage
Design
This open lable clinical trial study is a prospective group that will be conducted in one year in Al-Zahra Medical Center under the auspices of Isfahan University of Medical Sciences.34 people will enter the study
Settings and conduct
Our study will be performed in patients with spinal instability due to osteodicitis in Al-zahra Medical Center. The procedure will be done in posterior approach in the involved coulumn and two upper and lower level. 34 patients will be included and will be followed during 1 year base in VAS pain score. In this study, blindness was not performed and the treatment results in the intervention group will be compared before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patient, according to the specialist, is equal to the imaging findings with osteodiscitis with spinal instability. The patient underwent vertebral fusion surgery and anterior vertebral reconstruction without cage. Age range is 45 to 80 years. Patients with involvement of the thoracic, lumbar, and lumbosacral regions will be included in the study. The patient has the consent to participate in the study. Patients who fully participate in one-year follow-up.
Exclusion criteria: The patient not recourse for Follow up Patients with unstable systemic conditions Complete destruction of the vertebral body occurs in the upper or lower level of the disc.
Intervention groups
In the intervention group, the surgical technique is performed as a posterior aperture in the involved lobe, and the upper two level and the lower two lobe are involved in the involvement of the damaged disc and vertebra.
Main outcome variables
Pain, neurological deficit
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211012052738N1
Registration date:2021-11-13, 1400/08/22
Registration timing:registered_while_recruiting
Last update:2021-11-13, 1400/08/22
Update count:0
Registration date
2021-11-13, 1400/08/22
Registrant information
Name
Amirhosein Zohrehvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 9245 7485
Email address
ahz59dr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clinical and radiological results in patients with osteodiscosis with spinal instability operated by posterior aperture without cage
Public title
clinical and radiological results in patients with osteodiscosis with spinal instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient, according to the specialist, is equal to the imaging findings with osteodiscitis with spinal instability.
The patient underwent vertebral fusion surgery and anterior vertebral reconstruction without cage.
Age range is 45-80 years.
Patients with involvement of the thoracic, lumbar, and lumbosacral regions will be included in the study.
The patient has the consent to participate in the study.
Patients who fully participate in one-year follow-up.
Exclusion criteria:
The patient not recourse for Follow up
Patients with unstable systemic conditions
Complete destruction of the vertebral body occurs in the upper or lower level of the disc.
Age
From 45 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib St., Shiraz Gate
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-10-10, 1400/07/18
Ethics committee reference number
IR.MUI.MED.REC.1400.567
Health conditions studied
1
Description of health condition studied
Osteodiscits with spinal instability
ICD-10 code
M46.49
ICD-10 code description
Discitis, unspecified, multiple sites in spine
Primary outcomes
1
Description
Visual analogue scale pain score
Timepoint
Two weeks and one year after surgery
Method of measurement
Using a VAS (visual pain assessment questionnaire)
2
Description
neurological deficit
Timepoint
Two weeks and one year after surgery
Method of measurement
Clinical examination of the patient by a surgeon
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For this group, the surgical technique is performed as a posterior aperture in the involved lobe and the upper two lobe and the lower two lobe of the involved disc and vertebra.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Majid Rezvani
Street address
Al-Zahra hospital, Sofeh St.,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
m_rezvani@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Esfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, hezar jarib S.T
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@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
Majid Rezvani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
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
Isfahan
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
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
Amirhosein Zohrehvand
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
ahz59dr@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available