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
|
|
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
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - on request at email: drkatikar@gmail.com
- 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.
- 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 spondylolisthesisWe 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. |