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CTRI Number  CTRI/2025/03/083692 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 28/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Randomised control trial Comparing patient-specific surgical guides (PSSG) and conventional free-hand surgical methods in resource-constrained environment.  
Scientific Title of Study   Randomised control trial on precision and performance of 3D-printed patient-specific surgical guides (PSSG) in resource-constrained environments in comparison to conventional free-hand surgical methods. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vipin Chandran C  
Designation  Consultant 
Affiliation  BELIEVERS CHURCH MEDICAL COLLEGE HOSPITAL 
Address  Aayilliam , TC48/396-1 , NRA 64, Paravankunnu, Thiruvananthapuram.
Believers Church Medical college Hospital, P.B.31,St.ThomasNagar,KuttapuzhaP.O.,Thiruvalla-689103
Pathanamthitta
KERALA
695026
India 
Phone  9496369301  
Fax    
Email  bcmchneurosx@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vipin Chandran C  
Designation  Consultant 
Affiliation  BELIEVERS CHURCH MEDICAL COLLEGE HOSPITAL 
Address  Aayilliam , TC48/396-1 , NRA 64, Paravankunnu, Thiruvananthapuram.
Believers Church Medical college Hospital, P.B.31,St.ThomasNagar,KuttapuzhaP.O.,Thiruvalla-689103
Pathanamthitta
KERALA
695026
India 
Phone  9496369301  
Fax    
Email  bcmchneurosx@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vipin Chandran C  
Designation  Consultant 
Affiliation  BELIEVERS CHURCH MEDICAL COLLEGE HOSPITAL 
Address  Aayilliam , TC48/396-1 , NRA 64, Paravankunnu, Thiruvananthapuram.
Believers Church Medical college Hospital, P.B.31,St.ThomasNagar,KuttapuzhaP.O.,Thiruvalla-689103
Pathanamthitta
KERALA
695026
India 
Phone  9496369301  
Fax    
Email  bcmchneurosx@gmail.com  
 
Source of Monetary or Material Support  
Believers Church Medical college Hospital, P.B.31,St.ThomasNagar,KuttapuzhaP.O.,Thiruvalla-689103, kerala  
 
Primary Sponsor  
Name  Believers Church Medical college Hospital 
Address  Believers Church Medical college Hospital , P.B.31,St.ThomasNagar,KuttapuzhaP.O.,Thiruvalla-689103 
Type of Sponsor  Private medical college 
 
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 Vipin Chandran c   Belivers church medical college   Room no: A 3097 Third floor Department of Neurosurgery
Pathanamthitta
KERALA 		 9496369301

bcmchneurosx@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,BELIEVERS CHURCH MEDICAL COLLEGE HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  3D printed patient specific pedicle screw guide   3D printed patient specific pedicle screw guide will be used for surgery and its accuracy will be measured post operatively 
Comparator Agent  conventional free hand technique   Conventional free hand technique will be used to put pedicle screw s . Its accuracy will be compared with 3D printed PSSG 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients undergoing thoracic and lumbar pedicle screw fixation for traumatic and degenerative spinal disease.
Age more Than 18 years.
Informed consent obtained
 
 
ExclusionCriteria 
Details  Previous spinal surgery in the same level
Severe comorbidities that could affect healing or outcomes
Congenital deformities of spine
Pregnancy
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1)Accuracy of the surgical procedure
2)Measurement: Post-operative imaging (e.g., CT or X-ray) to assess medial, lateral, superior or inferior breach.

Secondary Outcomes:
Operative time (measured in minutes)
 Blood Loss
radiation exposure (number of shoots required)
Cost in Indian rupees

 		 At admission preop , post op at 1 week, at 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
1)Accuracy of the surgical procedure
2)Measurement: Post-operative imaging (e.g., CT or X-ray) to assess medial, lateral, superior or inferior breach.

Secondary Outcomes:
Operative time (measured in minutes)
 Blood Loss
radiation exposure (number of shoots required)
Cost in Indian rupees

 		 At admission preop , post op at 1 week, at 3 months  
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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 2/ Phase 3 
Date of First Enrollment (India)   10/04/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (NIL).

  6. For how long will this data be available start date provided 01-02-2026 and end date provided 28-02-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
 In spinal fusion, pedicle screws are utilized to stabilize the spine using a posterior approach. Traditional surgical techniques, like the insertion of a free-hand screw, mostly depend on the experience of the surgeon and anatomical landmarks.Pedicle screw insertion guided by images (Image guided surgery) can increase placement precision, but it is expensive.Research on patient-specific surgical guides (PSSG) made using that particular  patient’s scan data has demonstrated the need for reduced intra operative X-rays with comparable accuracy rates. 3D printed  PSSG also  reduces the  learning curve for the operating surgeon compared to conventional free hand technique. Our study is aimed at bringing out the advantages of 3D printed PSSG’s over traditional free hand technique especially in a resource constrained environment.Patients undergoing thoracic and lumbar pedicle screw fixation for traumatic and degenerative spinal disease , who satisfy the inclusion and exclusion criteria will be enrolled into 2 arms after randomization. Data will be collected after blinding and analyzed .
 
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