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CTRI Number  CTRI/2025/10/096453 [Registered on: 24/10/2025] Trial Registered Prospectively
Last Modified On: 22/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Skull bone replacement trial 
Scientific Title of Study   Comparative Study of Suture-Tied versus Titanium Plate Fixation in Cranioplasty Procedures 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jitin Bajaj 
Designation  Professor 
Affiliation  Netaji Subhash Chandra Bose Medical College 
Address  Room no. 6, IIIrd floor, Superspeciality Hospital, Netaji Subhash Chandra Bose Medical College, Jabalpur

Jabalpur
MADHYA PRADESH
482003
India 
Phone  8696982911  
Fax    
Email  bajaj.jitin@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jitin Bajaj 
Designation  Professor 
Affiliation  Netaji Subhash Chandra Bose Medical College 
Address  Room no. 6, IIIrd floor, Superspeciality Hospital, Netaji Subhash Chandra Bose Medical College, Jabalpur

Jabalpur
MADHYA PRADESH
482003
India 
Phone  8696982911  
Fax    
Email  bajaj.jitin@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jitin Bajaj 
Designation  Professor 
Affiliation  Netaji Subhash Chandra Bose Medical College 
Address  Room no. 6, IIIrd floor, Superspeciality Hospital, Netaji Subhash Chandra Bose Medical College, Jabalpur

Jabalpur
MADHYA PRADESH
482003
India 
Phone  8696982911  
Fax    
Email  bajaj.jitin@gmail.com  
 
Source of Monetary or Material Support  
Netaji Subhash Chandra Bose Medical College, Jabalpur - 482003, India 
 
Primary Sponsor  
Name  Netaji Subhash Chandra Bose Medical College 
Address  Netaji Subhash Chandra Bose Medical College, Jabalpur - 482003, India 
Type of Sponsor  Government 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 
Prof Jitin Bajaj  Netaji subhash Chandra Bose Medical College  Room no. 6, IIIrd floor, Superspeciality hospital, Department of Neurosurgery, Netaji subhash Chandra Bose Medical College, Jabalpur - 482003, India
Jabalpur
MADHYA PRADESH 
8696982911

bajaj.jitin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Netaji Subhash Chandra Bose Medical College, Jabalpur (MP)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S00-S09||Injuries to the head,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Suture-Tied Fixation  Cranioplasty will be done using Suture-Tied Fixation. The suture will be Silk 2-0 Round body. 
Comparator Agent  Titanium Plate Fixation  Cranioplasty will be done using Titanium Plate Fixation. The plates and screws will be made of titanium metal. Two to three plates will be placed. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Adult patients, post decompressive craniectomy defects 
 
ExclusionCriteria 
Details  Active infection, immunocompromised state, pediatric patients 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Titanium plate fixation may provide better structural integrity, but suture fixation may show similar clinical outcomes with reduced cost and resource use  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Both methods may show comparable complication rates  6 months 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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 4 
Date of First Enrollment (India)   10/11/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [bajaj.jitin@gmail.com].

  6. For how long will this data be available start date provided 01-12-2028 and end date provided 31-01-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Introduction

Cranioplasty is a surgical procedure aimed at repairing cranial defects resulting from trauma, decompressive craniectomy, tumor excision, or congenital anomalies. The choice of fixation technique plays an important role in postoperative outcomes. Titanium plates have been the gold standard due to their rigidity and biocompatibility. However, suture-tied fixation is a cost-effective and simpler method often preferred in resource-limited settings. This study aims to compare both methods in surgical outcomes, complication rates, and cost-effectiveness.

Need and Significance of the Study

There is limited comparative literature available evaluating suture-tied fixation with titanium plates in cranioplasty. With rising healthcare costs, assessing simpler and affordable alternatives without compromising outcomes is critical. This study may offer insights that can help guide surgical practices, especially in low-resource settings.

 
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