| CTRI Number |
CTRI/2022/02/040131 [Registered on: 09/02/2022] Trial Registered Prospectively |
| Last Modified On: |
13/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
questionnaire based evaluation |
| Study Design |
Other |
|
Public Title of Study
|
A questionnaire-based analysis of first seven consecutive cases of spine surgery. |
|
Scientific Title of Study
|
A prospective multicentric questionnaire-based evaluation of learning curve
of first seven consecutive cases of OLIF of a surgeon/institute. |
| Trial Acronym |
7OLIF |
|
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 |
No. 9, 2nd floor Annexe
Stavya Spine hospital & Research Institute
Ellisbridge, Mithakhali
Ahmedabad 380006 No. 9, 2nd floor Annexe
Stavya Spine hospital & Research Institute
Ellisbridge, Mithakhali
Ahmedabad 380006 Ahmadabad GUJARAT 380006 India |
| Phone |
9824302768 |
| Fax |
07926408174 |
| Email |
drajaykrishnan@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ajay Krishnan |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
No. 9, 2nd floor Annexe
Stavya Spine hospital & Research Institute
Ellisbridge, Mithakhali
Ahmedabad 380006 No. 9, 2nd floor Annexe
Stavya Spine hospital & Research Institute
Ellisbridge, Mithakhali
Ahmedabad 380006 Ahmadabad GUJARAT 380006 India |
| Phone |
9824302768 |
| Fax |
07926408174 |
| Email |
drajaykrishnan@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Ajay Krishnan |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
No. 9, 2nd floor Annexe
Stavya Spine hospital & Research Institute
Ellisbridge, Mithakhali
Ahmedabad 380006 No. 9, 2nd floor Annexe
Stavya Spine hospital & Research Institute
Ellisbridge, Mithakhali
Ahmedabad 380006 Ahmadabad GUJARAT 380006 India |
| Phone |
9824302768 |
| Fax |
07926408174 |
| Email |
drajaykrishnan@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Stavya Spine hospital & Research Institute
Ellisbridge, Mithakhali
Ahmedabad 380006 |
|
|
Primary Sponsor
|
| Name |
Stavya Spine Hospital and Research Institute |
| Address |
Stavya Spine hospital & 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 Ajay Krishnan |
Stavya Spine Hospital & Research Institute |
No. 9, 2nd floor Annexe
Stavya Spine hospital & Research Institute
Ellisbridge, Mithakhali
Ahmedabad 380006 Ahmadabad GUJARAT |
9824302768 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 |
| Healthy Human Volunteers |
Surgeons who use OLIF technique |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
First seven consecutive cases of the surgeon |
|
| ExclusionCriteria |
| Details |
If any loss of data (LOD) of first cases is there, then subsequent cases can be taken. But need to be mentioned about LOD. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of learning curve in first seven cases of OLIF and measures taken to overcome the hindrance in operative interventions |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Questionnaire based evaluation will provide new insights in operative technique in OLIF.
Additionally, the more experienced surgeons of OLIF will add valuable tricks and tips in addition to these 7 cases to highlight and overcome learning curves and outcomesquestionnaire to complete the spectrum, and inclusiveness of the objective. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/02/2022 |
| 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="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
Lumbar interbody fusion (LIF) is a
treatment strategy for various spinal disorders, including unstable
degenerative conditions not limited to trauma, infection and neoplasia. An LIF
can be achieved via posterior approaches, transforaminal interbody Fusion
[TLIF] and posterior lumbar interbody fusion [PLIF], and the anterolateral
approaches, anterior lumbar interbody Fusion [ALIF], transpsoas lateral lumbar
interbody Fusion [LLIF] and oblique lumbar interbody Fusion [OLIF]. Posterior
approaches disrupt the posterior tension band, cause iatrogenic injury to
paraspinal musculature, and have limited endplate exposure restricted by thecal
sac and nerve roots, which may cause difficulty in correcting coronal imbalance
and lordosis restoration.
There is a substantial obvious
learning curve in OLIF. Though conventional Indian surgeons have been exemplanary
in open anterior approaches in India. Newer established surgeons who are more
familiar with minimally invasive spine surgeries or open common approach may
not adopt to anterior approaches soon as the trainings in last decade was
towards versatile dorsal approach Instrumentation System based OLIF and cost
sensitivity may be another issue to have prevented its general application in India. |