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CTRI Number  CTRI/2022/02/040500 [Registered on: 22/02/2022] Trial Registered Prospectively
Last Modified On: 06/07/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Other 
Public Title of Study   Vertebral biopsy: Navigated under advanced technology.(Integrated Operation Theater Spine Suite) 
Scientific Title of Study   Transpedicular Vertebral biopsy: Navigated Biopsy technique Improvisation with Integrated Operation Theater Spine Suite (IOTSS) 
Trial Acronym   
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 and 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 and Research Institute Ellisbridge Mithakhali Ahmedabad 380006


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 and Research Institute Ellisbridge Mithakhali Ahmedabad 380006


GUJARAT
380006
India 
Phone  9824302768  
Fax  07926408174  
Email  drajaykrishnan@yahoo.co.in  
 
Source of Monetary or Material Support  
No. 9 2nd floor Annexe Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad 380006 
 
Primary Sponsor  
Name  Stavya Spine Hospital and Research Institute 
Address  No. 9 2nd floor Annexe Stavya Spine hospital and 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 and 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 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patient indicated for biopsy.
 
 
ExclusionCriteria 
Details  Not fitting in inclusion criteria. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary objective of the present study is to add additional technique modification of biopsy in spine specifically with IOTS to get quality samples in precious biopsy, soft material biopsy or a hard sclerotic lesion.  1 month 
 
Secondary Outcome  
Outcome  TimePoints 
The Secondary objective is to describe the technical steps in achieving biopsy sample.  1 month 
 
Target Sample Size   Total Sample Size="1"
Sample Size from India="1" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="1" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/02/2022 
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="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
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  

Symptomatic vertebral and disco-vertebral lesions are often detected radiologically but are diagnosed with variable accuracy ranging from 95% for lytic lesions to 42% for mixed pathologies. Management of spinal lesions depends largely on highly specific modalities like biopsy and histopathology. The first ever transpedicular(TP) biopsy(TPB) was performed by Stringham et al in 1994. Pedicle has been used as a gateway to vertebral body either via open or minimally invasive methods owing to our understanding of vertebral anatomy and experience with TP fixation. Despite emerging techniques, sample inadequacy remains the most important factor that necessitates the need for a repeat biopsy. The TPB has a diagnostic accuracy ranging from 75% -90% in both CT guided radio-diagnostic centre biopsy as well as percutaneous biopsy in operation theatre. Presenting here in this article is an add on technique as a modification to enhance the quality and quantity of sample obtained by using a biopsy cannula, thereby increasing the diagnostic yield of TPB, in turn guiding towards an appropriate line of management. The authors have utilized the similar cannula that was used for the percutaneous continuous drainage (PCD-2014) of psoas abscess and TPB( 2009). These conventional techniques  were pioneered by Dr Bharat R Dave and has contributed immensely to the patient diagnosis and treatment nationally and practiced by spine surgeons on daily basis now .

Objective:

The primary objective of the present study is to add additional technique modification of biopsy in spine specifically with IOTS to get quality samples in precious biopsy, soft material biopsy or a hard sclerotic lesion. The objective is to describe the technical steps in achieving it supported by pictures and images acquired in one patient already operated. 


 
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