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CTRI Number  CTRI/2021/03/032218 [Registered on: 23/03/2021] Trial Registered Prospectively
Last Modified On: 19/03/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Correlation between slippage between two adjacent vertebrae on lateral flexion x-ray and the obliquity of the exiting nerve root as measured on on the MRI of lumbo-sacral spine.  
Scientific Title of Study   Correlation between spondylisthesis on lateral flexion x-ray and obliquity of the exiting nerve root on the MRI of lumbo-sacral spine. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr DB Katikar 
Designation  Chief Neurosurgeon/ Director 
Affiliation  Balwant Institute of Neurosciences and Intensive Trauma care 
Address  Balwant Institute of Neurosciences and Intensive Trauma care, 111, Modikhana, Saat Raasta, Solapur.

Solapur
MAHARASHTRA
413001
India 
Phone    
Fax    
Email  drkatikar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr DB Katikar 
Designation  Chief Neurosurgeon/ Director 
Affiliation  Balwant Institute of Neurosciences and Intensive Trauma care 
Address  Balwant Institute of Neurosciences and Intensive Trauma care, 111, Modikhana, Saat Raasta, Solapur.


MAHARASHTRA
413001
India 
Phone    
Fax    
Email  drkatikar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr DB Katikar 
Designation  Chief Neurosurgeon/ Director 
Affiliation  Balwant Institute of Neurosciences and Intensive Trauma care 
Address  Balwant Institute of Neurosciences and Intensive Trauma care, 111, Modikhana, Saat Raasta, Solapur.


MAHARASHTRA
413001
India 
Phone    
Fax    
Email  drkatikar@gmail.com  
 
Source of Monetary or Material Support  
Balwant institute of neurosciences and intensive traumacare, Solapur, Maharashtra 
 
Primary Sponsor  
Name  Balwant Institute of Neurosciences and Intensive Trauma care 
Address  Balwant Institute of Neurosciences and Intensive Trauma care, 111, Modikhana, Saat raasta Solapur, Maharashtra 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr DB Katikar  Balwant Institute of Neurosciences and Intensive Trauma care  Department of Neurosurgery, 111, Modikhana, Saat Raasta Solapur, Maharashtra.
Solapur
MAHARASHTRA 
9822072410

drkatikar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), Dr. VMGMC, Solapur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G544||Lumbosacral root disorders, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1.)Patients with backache and leg pain.
2.)Patients with lumbosacral radiculopathy.
 
 
ExclusionCriteria 
Details  Patients who cannot cooperate for study
1.)Patients x-Ray with implants in spine.
2.)Patients who have trauma, infection, tumor as a cause of their lumbosacral radiculopathy.
3.)Patients who have undergone lumbosacral spine surgery with stabilization.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.)Angle of obliquity of the exiting nerve root.
2.) Presence/absence of spondylolisthesis 
at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
the sensitivity of the test, the specificity of the test, the predictive value of a positive test, and the predictive value of a negative test.  at baseline 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/03/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  on request at email: drkatikar@gmail.com

  6. For how long will this data be available start date provided 25-03-2021 and end date provided 14-10-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   MRI has become an investigation of choice for patients of low back pain with radiculopathy. MRI doesn’t consistently detect spondylolisthesis. In far lateral sagittal T2 MRI images, exiting nerve roots are seen descending vertically. We observed that the obliquity of these descending nerve roots may be related to spondylolisthesis

We plan to study prospectively study about 200 patients who have attended our OPD department for consultation for lumbosacral radiculopathy in the next two years.   

We will do a thorough clinical examination after noting down the history.  We will study their MRI lumbosacral spine and lateral flexion-extension X-rays for the presence or absence of listhesis.

We will consider spondylolisthesis to be present when vertebral slip is seen greater than three millimeters on lateral standing flexion-extension radiographs.   

For objectively measuring the obliquity of the exiting nerve root, we have described an angle which the exiting nerve root makes with the body of a vertebra.  We will select far lateral sagittal T2 weighted image just lateral to the facet joints or the image which clearly shows exiting nerve roots coming out of intervertebral foramen in an inverted teardrop manner.  We will draw a line parallel to the lower endplate of the vertebra and another line along the exiting nerve root and will measure the angle between these two lines. This we will consider ‘Angle of the obliquity of the exciting nerve root’ 

We will study the correlation of this obliquity of exiting nerve root on lateral sagittal MRI images with spondylolisthesis on standing lumbosacral spine lateral flexion-extension X-rays.

Statistically, we will find out (1) the sensitivity of our test, (2) the specificity of our test, (3) the predictive value of a positive test, and (4) the predictive value of a negative test.  

We may thus be able to prove the correlation between obliquity of the exiting nerve root on MRI and spondylolisthesis on flexion-extension X-rays.

If it can be established then it will become a sign on MRI to diagnose spondylolisthesis with great accuracy and will obviate the need for additional investigation, i.e. lateral flexion-extension X-ray of the lumbosacral spine which at present is considered to be the gold standard to diagnose spondylolisthesis.  

 
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