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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Surgeons who use OLIF technique 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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