| CTRI Number |
CTRI/2021/04/032957 [Registered on: 20/04/2021] Trial Registered Prospectively |
| Last Modified On: |
13/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective & Prospective |
| Study Design |
Other |
|
Public Title of Study
|
An Observational & analysis of use, advantages, disadvantages & significance of neuromonitoring in spine surgeries.
|
|
Scientific Title of Study
|
An Observational retrospective & prospective analysis of use, advantages, disadvantages & significance of intraoperative neuromonitoring in spine surgeries.
|
| Trial Acronym |
IONM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajay Krishnan |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
Stavya Spine Hospital & Research Institute Annexe building 2nd floor
Near Nagri Hospital, Mithakhali, Ellisbridge
Ahmedabad
Stavya Spine Hospital & Research Institute Annexe building 2nd floor
Near Nagri Hospital, Mithakhali, Ellisbridge
Ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
09824302768 |
| Fax |
07926408174 |
| Email |
drajaykrishnan@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Birju K Vyas |
| Designation |
Chief Physiotherapist |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
Stavya Spine Hospital & Research Institute Annexe building 2nd floor
Near Nagri Hospital, Mithakhali, Ellisbridge
Ahmedabad
Stavya Spine Hospital & Research Institute Annexe building 2nd floor
Near Nagri Hospital, Mithakhali, Ellisbridge
Ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
09925248584 |
| Fax |
07926408174 |
| Email |
birju_spine@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Birju K Vyas |
| Designation |
Chief Physiotherapist |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
Stavya Spine Hospital & Research Institute Annexe building 2nd floor
Near Nagri Hospital, Mithakhali, Ellisbridge
Ahmedabad
Stavya Spine Hospital & Research Institute Annexe building 2nd floor
Near Nagri Hospital, Mithakhali, Ellisbridge
Ahmedabad
GUJARAT
380006
India |
| Phone |
09925248584 |
| Fax |
07926408174 |
| Email |
birju_spine@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Stavya Spine Hospital and Research Institute |
| Address |
Stavya Spine Hospital & Research Institute Annexe building 2nd floor
Near Nagri Hospital, Mithakhali, Ellisbridge
Ahmedabad |
| 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 Ajay Krishnan |
Stavya Spine Hospital & Research Institute |
Stavya Spine Hospital & Research Institute Annexe building 2nd floor
Near Nagri Hospital, Mithakhali, Ellisbridge
Ahmedabad
Ahmadabad
GUJARAT |
09824302768
07926408174
drajaykrishnan@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: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) Any Patient operated any spine surgery using IONM.
2) Age: 1 to 90 Years
3) Patient willing to give consent and participate in the study
4) Psychosocially, mentally and physically able to fully comply with this protocol in-cluding
adhering to completing forms and other study procedures.
5) Personally, signed and dated informed consent document prior to any study-related
procedures indicating that the patient has been informed of all pertinent aspects of the study
|
|
| ExclusionCriteria |
| Details |
1. Any patient operated without using IONM.
2. Patient not willing to participate in the study or not willing to sign the consent form.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Single time Evaluation of significance, advantages & disadvantages of IONM (Intraoperative Neuromonitoring) specifically in spine surgery in our tertiary care set up.
|
2 Years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Factors affecting specificity & accuracy will be ruled out.
|
2 Years |
|
|
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)
|
20/04/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single center, retrospectively
& prospectively analytic study. Patients
will be evaluated in follow-up visit overtime to know if patient recovered
really in follow up times.
A total minimum of 200 (All previous
operated and coming two years data) patients who meet the inclusion / exclusion
criteria will be enrolled in the study.
The total duration of this study is
expected to be up to 12-24 months.
During the study IONM data
of patients operated for various spinal surgery with the help of IONM will be
assessed and analyzed. In this study advantages & disadvantages of the use
of IONM in spine surgeries will be assessed. Factors affecting specificity
& accuracy will be ruled out. |