| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bajaj.jitin@gmail.com].
- 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.
- 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. |