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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
Intervention / Comparator Agent
|
|
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.
|