| CTRI Number |
CTRI/2017/08/009540 [Registered on: 29/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
13/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An MRI based study to know the changes in operative site after 1 year in patients operated for one level lower back operation. |
|
Scientific Title of Study
|
A Prospective Analysis of MRI of fibrosis in post-operative TLIF Patients, Conventional Vs MISS |
| Trial Acronym |
Nil |
|
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 & Associate Consultant Spine Surgeon |
| Affiliation |
Stavya Spine Hospital and Research Institute |
| Address |
Stavya Spine Hospital and Research Institute
Nr Nagari Hospital
Mithakhali Ellisbridge
Ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
07874444091 |
| Fax |
07926408174 |
| Email |
drdanand@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Devanand |
| Designation |
Principal Investigator & Associate Consultant Spine Surgeon |
| Affiliation |
Stavya Spine Hospital and Research Institute |
| Address |
Stavya Spine Hospital and Research Institute
Nr Nagari Hospital
Mithakhali Ellisbridge
Ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
07874444091 |
| Fax |
07926408174 |
| Email |
drdanand@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Jinal Patel |
| Designation |
Clinical Research Co-ordinator |
| Affiliation |
Stavya Spine Hospital and Research Institute |
| Address |
Stavya Spine Hospital and Research Institute
Nr Nagari Hospital
Mithakhali Ellisbridge
Ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
09898953922 |
| Fax |
07926408174 |
| Email |
crcstavya@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Stavya Spine Hospital and Research Institute |
| Address |
Stavya Spine Hospital and Research Institute
Nr Nagari 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 D Devanand |
Stavya spine Hospital and Research Institute |
Spine Research Wing
Stavya Spine Hospital and Research Institute
Nr Nagari Hospital
Mithakhali Ellisbridge
Ahmedabad
Ahmadabad
GUJARAT |
07926565757
7926408174
drdenishpatel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Stavya Spine Hospital and Research Institute Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
TLIF surgery Conventional or MISS , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Single level Lumbar or lumbosacral fusion operated by conventional approach or MISS technique
2. Psychologically, mentally & physically able to fully comply with this protocol including adhering to completing forms & other study procedures.
3. 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. Redo lumbar surgeries
2. Lumbar infection
3. Multilevel lumbar fusion
4. Lumbar laminectomy
5. Lumbar discectomy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| radiological . MRI parameters at work station. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| radiological . MRI parameters at work station. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2016 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, prospective, single centre study analysing the radiological MRI based changes of various muscle groups in the operative site in patients operated for single level lumbar or lumbosacral fusion surgery one year prior to the study initiation time. The primary outcome would be various MRI findings of fibrosis in posterior muscle groups for 2 years. |