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CTRI Number  CTRI/2023/03/050547 [Registered on: 10/03/2023] Trial Registered Prospectively
Last Modified On: 10/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Guidance for Screw Insertion in Spine Surgery 
Scientific Title of Study   Navigation assisted guidance for Pedicle Screw Insertion in Spine Surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shyamasunder Bhat N 
Designation  Professor and Head 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Orthopaedics Kasturba Medical College Manipal Manipal Academy of Higher Education
Manipal - 576104
Udupi
KARNATAKA
576104
India 
Phone  9480486075  
Fax  8202571934  
Email  shyambhat.n@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Shyamasunder Bhat N 
Designation  Professor and Head 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Orthopaedics Kasturba Medical College Manipal Manipal Academy of Higher Education
Manipal - 576104
Udupi
KARNATAKA
576104
India 
Phone  9480486075  
Fax  8202571934  
Email  shyambhat.n@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Shyamasunder Bhat N 
Designation  Professor and Head 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Orthopaedics Kasturba Medical College Manipal Manipal Academy of Higher Education
Manipal - 576104
Udupi
KARNATAKA
576104
India 
Phone  9480486075  
Fax  8202571934  
Email  shyambhat.n@manipal.edu  
 
Source of Monetary or Material Support  
Science and Engineering Research Board and Wipro GE HealthCare Pvt Ltd  
 
Primary Sponsor  
Name  Science and Engineering Research Board 
Address  3rd and 4th Floor, Block II , Technology Bhavan New Mehrauli Road, New Delhi-110016 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Wipro GE HealthCare Pvt Ltd  No. 4, Kadugodi Industrial Area, Bangalore 560067, Karnataka, India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Roshan Naik  Kasturba Medical College, Manipal  Department of Orthopaedics, Room No. 4, Ground Floor, Manipal Academy of Higher Education, Manipal 576104
Udupi
KARNATAKA 		 9740121777

roshannaik10091983@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC and KH Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: S320||Fracture of lumbar vertebra,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Navigation assisted guidance for Pedicle Screw Insertion in Spine Surgery  PI and Co-PI from MAHE will ascertain that they have the relevant computational infrastructure for algorithm and User-interface (UI) development, for designing the surgical-template. Within the first one month of the project kick-off, twenty datasets (CT image data of twenty patients – ten datasets for spine-junctions, and ten datasets for thoraco-lumbar deformed spine) will be leveraged for starting the design/development work from external source Once the basic library is ready, UI development for template/screw-guide import/superposition and congruence, will commence, and ten additional datasets will be provided from external source for validation of the algorithm/UI. Validation will be carried out on all the above datasets, to understand the capabilities and inadequacies of the algorithm/UI. Refining of the algorithm/UI will be carried out, and the yearly report will be shared with GEHC & SERB, while the monthly discussions between GEHC, and MAHE will be an ongoing op-mech for the entire duration of the project. The funding is by GEHC through SERB. At the start of the second year, further evaluations of the tool (design + UI) will be done on twenty more datasets, and the workflow for 3D-printing the templates will be setup. Any further refinements to the customized simulation engine, will be carried out and a half yearly report (for the 1st half of the 2nd year) will be shared with GEHC and SERB. Twenty more datasets will be leveraged post that, for a through validation of the algorithm/UI and the printed templates. The last three months will be leveraged for driving the project towards completeness in terms of reports, reviews, and clinical demonstrations. A total of 20 datasets (Postoperative CT scans of 20 thoracolumbar burst fractures) will be used from Kasturba Medical College, Manipal whereas 50 other datasets from external source provided by GEHC also will be analysed.  
Comparator Agent  Not Applicable  Not Applicable  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  20 consecutive cases of thoracolumbar burst fractures who have undergone surgical stabilization will be selected and subjected to CT scans. 
 
ExclusionCriteria 
Details  Those who are not consenting to participate are excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Agreement between software prediction and actual position of screw and feasibility of integration in the advanced workstation software. The last three months will be leveraged for driving the project towards completeness in terms of reports, reviews, and clinical demonstrations.   2 Years 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/04/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   66. Naik, R.R., Anitha H, Bhat, S.N. et al. Realistic C-arm to pCT registration for vertebral localization in spine surgery. Med Biol Eng Comput 2022; 60: 2271-89. DOI:10.1007/s11517-022-02600-5. 67. Naik RR, Hoblidar A, Bhat SN, Ampar N, Kundangar R. A Hybrid 3D-2D Image Registration Framework for Pedicle Screw Trajectory Registration between Intraoperative X-ray Image and Preoperative CT Image. Journal of Imaging 2022; 8(7):185. DOI:10.3390/jimaging8070185.  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study aims at developing algorithms and software tools for designing patient-specific precision surgical aids – specifically, the developments related to design and import of surgical templates, particularly the patient-specific screw-guides for surgeries on spine junctions and thoraco-lumbar deformed spine.

Objectives are

To develop algorithms and user-interface capabilities, for

a. Building a library of surgical templates, using a design tool like CAD

b. A user-interface to customize the template/screw-guide for every patient, by super-posing the library-file on to the CT images of the patient (User Interface should have features like stretch, rotate, measure, etc – like, insert object and resize), and achieve best congruence

 
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