| CTRI Number |
CTRI/2022/09/045279 [Registered on: 07/09/2022] Trial Registered Prospectively |
| Last Modified On: |
13/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Analysis of the requirement of Neck MRI with movement & its findings |
|
Scientific Title of Study
|
“Kinematic Cervical MRI - An insight into indications and radiological findings - A retrospective radiological analysis†|
| Trial Acronym |
RetroKCM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr D Devanand |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
No. 9 2nd floor Annexe
Research department
Stavya Spine hospital
and Research Institute
Ellisbridge Mithakhali
Ahmedabad 380006
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT
380006
India |
| Phone |
7874444091 |
| Fax |
07926408174 |
| Email |
drdanand@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Devanand |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
No. 9 2nd floor Annexe
Research department
Stavya Spine hospital
and Research Institute
Ellisbridge Mithakhali
Ahmedabad 380006
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT
380006
India |
| Phone |
7874444091 |
| Fax |
07926408174 |
| Email |
drdanand@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr D Devanand |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
No. 9 2nd floor Annexe
Research department
Stavya Spine hospital
and Research Institute
Ellisbridge Mithakhali
Ahmedabad 380006
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT
380006
India |
| Phone |
7874444091 |
| Fax |
07926408174 |
| Email |
drdanand@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad 380006 |
|
|
Primary Sponsor
|
| Name |
Stavya Spine Hospital and Research Institute |
| Address |
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali
Ahmedabad 380006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 D Devanand |
Stavya Spine Hospital & Research Institute |
No. 9 2nd floor Annexe
Research department
Stavya Spine hospital
and Research Institute
Ellisbridge Mithakhali
Ahmedabad 380006
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT |
7874444091
07926408174
drdanand@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Stavya Spine hospital & Research Institute IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M953||Acquired deformity of neck, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patient who underwent dynamic cervical spine MRI |
|
| ExclusionCriteria |
| Details |
â— Incomplete data
â— Poor quality MRI
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Single time analysis of all the patient who underwent cervical spine kinematic MRI at our institute |
As the study is retrospective no clinical visits required. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Statistical and accessory noninvasive information which will be collected as found additionally of importance.
|
Patients who underwent cervical spine kinematic MRI at our institute from 2017 to 2022 will be retrospectively evaluated for various radiological parameters.
|
|
|
Target Sample Size
|
Total Sample Size="380"
Sample Size from India="380"
Final Enrollment numbers achieved (Total)= "380"
Final Enrollment numbers achieved (India)="380" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/09/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cervical spondylotic myelopathy (CSM) is the most severe
type of cervical spondylosis and the most common cause of spinal cord
dysfunction among adults over 55 years old. The clinical syndrome of CSM occurs when the stenosis
impinges on the spinal cord, and the severity of CSM is generally thought to be
related to the amount of mechanical compression of the various spinal cord
tracts .Dynamic MRI is done with flexion and extension position
of cervical spine, which mimicks the natural movements of cervical spine
thereby identifying the pathologies more precisely[1, 6–11].Dynamic MRI (dMRI)
is firstly described in 1980s, which is a modification of static MRI. It is
studied that changes of spinal stenosis that are possibly missed on the static
MRI , would be picked up on
dMRI. Extension MRI might help to identify significant cervical canal
stenosis that is partially or completely absent on neutral and flexion MRI.
Flexion MRI permits better visualization of cord changes on T2-weighted
images.
|