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CTRI Number  CTRI/2022/02/040128 [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   Retrospective 
Study Design  Other 
Public Title of Study   Comparative analysis of bare window in Spinal fusion surgeries in age related lumbar deformities.  
Scientific Title of Study   Comparative morphometric analysis of bare window in oblique lumbar interbody fusion in degenerative lumbar scoliosis. 
Trial Acronym  Bare OLIF 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrDDevanand 
Designation  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  09925248584  
Fax  07926408174  
Email  drdanand@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  DrDDevanand 
Designation  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

GUJARAT
380006
India 
Phone  09925248584  
Fax  07926408174  
Email  drdanand@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DrDDevanand 
Designation  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

GUJARAT
380006
India 
Phone  09925248584  
Fax  07926408174  
Email  drdanand@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 
DrDDevanand  Stavya Spine Hospital & Research Institute  No. 9, 2nd floor Annexe Stavya Spine hospital & Research Institute Ellisbridge, Mithakhali Ahmedabad 380006
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  90.00 Year(s)
Gender  Male 
Details  1.Cobbs angle measured from L1 superior end plate to S1 superior end plate in anteroposterior radiographs
2.Angle <10 degree will be included in N Group, >10 degree with left sided convexity than included in L group and >10 degree with right sided convexity than included in D group
 
 
ExclusionCriteria 
Details  • T2W axial images were analysed and images that were not parallel to the end-plate
• Patient not fulfilling inclusion criteria
• Patients with infection, trauma, tumours, idiopathic scoliosis, old operated for lumbar spine and/or history of retroperitoneal surgeries.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in lumbar curvature in lumbar degenerative scoliosis leads to changes in bare window for OLIF.   6 months  
 
Secondary Outcome  
Outcome  TimePoints 
Changes in lumbar curvature in lumbar degenerative scoliosis leads to changes in bare window for OLIF.   6 months 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" 
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.

The indications of OLIF have expanded overtime to include a wide spectrum of degenerative disorders from single level lumbar pathology to multilevel adult degenerative scoliosis (ADS). Large sized spacers are thought to be effective in restoring sagittal and coronal balance of patients in ADS. For a spine surgeon, clear understanding of the local anatomical features and surgical corridors help in achieving a good outcome.

The Objectives of the study are : 

To measure OLIF operative windows from L2–L3 to L4–L5 level in normal patients and patients with ADS.

To assess various anatomical changes that determine the feasibility of OLIF technique following MRI based morphometric evaluation in ADS


 
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