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CTRI Number  CTRI/2024/10/075894 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 23/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Other 
Public Title of Study   Is it better to stimulate inside the pedicle hole before putting the pedicle screw and then stimulating the screws? 
Scientific Title of Study   Diagnostic accuracy of pedicle screw placement using triggered electromyographic thresholds from stimulation over the pedicle screw compared to the stimulation within the pedicle hole.  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vasantha Kumar  
Designation  Neurosurgery registrar 
Affiliation  Christian medical college Vellore-Ranipet campus 
Address  Department of neurological sciences CMC Vellore-Ranipet campus Kilminnal Village Ranipet

Vellore
TAMIL NADU
632517
India 
Phone  6382660258  
Fax    
Email  vasanthjoic@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Krishna Prabhu 
Designation  Professor- Neurosurgery  
Affiliation  Christian medical college Vellore-Ranipet campus 
Address  Professor and Head of unit 1 Dept of neurological sciences Christian Medical college Vellore Ranipet campus Kilminal village Ranipet

Vellore
TAMIL NADU
632517
India 
Phone  9843791380  
Fax    
Email  Krishnaprabhu@cmcvellore.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Sajo thomas 
Designation  Neurophsyiologist 
Affiliation  Christian medical college Vellore-Ranipet campus 
Address  Asst Prof Neurophysiology unit Dept of Neurological sciences CMC Vellore Ranipet campus

Vellore
TAMIL NADU
632517
India 
Phone  9535709051  
Fax    
Email  sajo.thomas@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Christian Medical College Vellore-Ranipet campus Kilminnal village Ranipet district Tamil nadu India Pin code: 632517  
 
Primary Sponsor  
Name  Christian medical college Velloreranipet campus 
Address  Kilminnal village Ranipet district Tamil nadu India Pin code 632517 
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 Vasantha Kumar   Christian medical college Vellore  Department of neurological sciences Kilminnal village Ranipet Pin 632517
Vellore
TAMIL NADU 		 6382660258

vasanthjoic@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Office of Research, Ist Floor, Carman Block, Christian Medical College, Vellore, Tamil Nadu   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M472||Other spondylosis with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pedicle hole stimulation  0 – 30 mA; stepwise increase in current. tEMG is measured from the lower limb muscles is recorded. Total duration : 5 minutes 
Intervention  Pedicle screw stimulation  0 – 30 mA; stepwise increase in current. tEMG is measured from the lower limb muscles is recorded. Total duration: 5 minutes Finally, we measure the sensitivity and specificity of pedicel hole vs pedicle screw stimulation.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adults posted for Lumbar posterior instrumentation with pedicle screw constructs for various pathologies at our institution over a 2-year period.

Pedicle screw instrumentation in L1 to S1 levels will be shortlisted.

The first 50 patients will be included.  
 
ExclusionCriteria 
Details  Dysmorphic pedicle features
Pedicle screws other than T12 to S1 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Additional method to affirm the proper placement of the pedicle screw inside the
spine bone. 		 2-3 YEARS 
 
Secondary Outcome  
Outcome  TimePoints 
EMG threshold values/sensitivity/specificity of pedicle hole stimulation & Pedicle screw stimulation.  at baseline 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="6"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The use of pedicle screws is a globally practised standard for all surgical treatments for spinal pathologies like deformity correction, degenerative disks, spondylolisthesis, etc. The risk is potential canal perforation resulting in irritation or compression of nerve roots. Malposition of PS can lead to structural instability and new onset motor or sensory deficits postoperatively. To decrease this risk, pedicle screw (PS) stimulation, an intraoperative neurophysiological monitoring (IONM) technique, was introduced to ascertain the proper placement of the PS into the pedicle hole along with other techniques like intraoperative fluoroscopy, direct inspection, and neuronavigation. Direct stimulation over the pedicle screw has been shown to have high specificity but clinically unacceptable low sensitivity. Hence, triggered electromyographic (t-EMG) cannot be solely relied upon for appropriate PS placement. However, using a stimulating probe inside the pedicle hole showed higher sensitivity than PS stimulation. In this study, we want to compare the diagnostic accuracy of pedicle hole stimulation with that of pedicle screw stimulation.  
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