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CTRI Number  CTRI/2018/10/016039 [Registered on: 16/10/2018] Trial Registered Prospectively
Last Modified On: 14/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   3D Printing applications for reconstruction of facial defects 
Scientific Title of Study   An Exploratory Study to Evaluate Surgical Outcome and Financial Burden in Patients Treated with 3D Printing Technology Assisted Surgery versus Conventional Surgery for Facial Fractures at Level 1 Trauma Centre, AIIMS, New Delhi. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ruchi Pathak Kaul 
Designation  Women Scientist Fellow PhD Scholar 
Affiliation  JPN Apex Trauma Centre AIIMS New Delhi 
Address  Room no 306 3rd floor JPN Apex Trauma Centre AIIMS New Delhi

New Delhi
DELHI
110029
India 
Phone  09650777017  
Fax    
Email  ruchi8380@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sushma Sagar 
Designation  Professor 
Affiliation  JPN Apex Trauma Centre AIIMS New Delhi 
Address  Room no 306 3rd floor JPN Apex Trauma Centre AIIMS New Delhi

New Delhi
DELHI
110029
India 
Phone  09650777017  
Fax    
Email  sagar.sushma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ruchi Pathak Kaul 
Designation  Women Scientist Fellow PhD Scholar 
Affiliation  JPN Apex Trauma Centre AIIMS New Delhi 
Address  Room no 306 3rd floor JPN Apex Trauma Centre AIIMS New Delhi

New Delhi
DELHI
110029
India 
Phone  09650777017  
Fax    
Email  ruchi8380@gmail.com  
 
Source of Monetary or Material Support  
AIIMS 
 
Primary Sponsor  
Name  All India Institute of Medical SciencesNew Delhi 
Address  Ansari nagar New Delhi 
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 Ruchi Pathak Kaul  JPN Apex Trauma Centre AIIMS New Delhi  Room no 306 3rd floor JPN Apex Trauma Centre AIIMS New Delhi
New Delhi
DELHI 
9650777017

ruchi8380@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
InstitutionalEthicalCommitteeAIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: V196||Unspecified pedal cyclist injuredin collision with other and unspecified motor vehicles in traffic accident,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Patient Specific 3D Printed Titanium Implant  Made of medical grade/Type 4 titanium trail duration is total 2 years 
Comparator Agent  pre fabricated titanium plates  titanium plates of fixed design 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Both male and females ,
2.Age:18-65 years
3.GCS> 13
4.Secondary facial deformities
 
 
ExclusionCriteria 
Details  1.Patient not giving informed consent
2.GCS< 13
3.Fresh facial Injuries
4.Evidence of infection with HIV/hepatitis B
5.Pregnancy/Breastfeeding
6.Underlying Systemic disorders
• Patient on
i. Steroids
ii. Immuno-modulator drugs
iii. Blood thinners
iv. Anti-Psychotic drugs
v. having cardiac surgeries in last 6 months
• Uncontrolled Diabetes
• Infection at local site
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
decrease number of surgeries
improved quality of life
decreased surgicaltime 
decrease number of surgeries(while planning pre op)
improved quality of life(pre op,3,6mons)
decreased surgicaltime(at time of surgery) 
 
Secondary Outcome  
Outcome  TimePoints 
less financial implications
better accuracy 
6 months 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   23/10/2018 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  


Reconstruction of maxillofacial defects has always been a challenging task for the scientist and surgeons over the years. The main goal of the reconstruction of the maxillofacial region is to restore facial form, function, full rehabilitation of occlusion and articulation [1].Autogenous bone grafts are still considered the gold standard for reconstructive bone surgery [2]. However, donor site morbidity and limited availability are of concern [3].Reconstructive Surgery is evolving into a multidisciplinary field where surgeon needs to work with scientist and engineers to develop alternative approaches to decrease side effects associated with surgery. Elimination of surgery is unrealistic but newer technologies may reduce number of procedures and improve outcome of surgery.

Additive Manufacturing, a process of joining materials to build objects, was invented in 1980 but its greatest momentum has been in the 21st century due to its accessibility to different sectors including healthcare. The term Stereo lithography was coined in 1986 by Chuck Hull, who patented creating 3D objects by depositing thin layers and curing with ultraviolet light, starting from bottom to top.3D technology ranges from contour models, guides, splints and Patient Specific Implants. The application of this technology has grown across sectors in industry while in medicine it has grown from diagnosis and educational models to medical devices and surgical applications of patient specific data. The most common medical modelling software is Mimics and the most common printing software being 3D Systems. Patient specific implants have superior anatomical matching and can be custom designed as per the defect. The 3-D Technologies hold great potential in improving surgical outcome in terms of form, function, finances and time-frame. We therefore have a scope to identify the evidence for improvements in the surgical outcome by incorporation of 3D technologies into routine surgeries. Presently, lack of high level evidence remains a barrier to assessing the effectiveness of the technology, therefore opening future research opportunities. Other barriers to the incorporation of 3D Printing Technologies include little awareness among surgeons about the technological aspect, high cost of the modelling and printing software along with cost involved file conversions, cost of materials to be used, additional time taken for the entire process and lack of infrastructure. A hospital based 3D Printing Technology laboratory can positively decrease cost of Patient Specific Implants (PSI) and enhance surgical outcome while incorporating 3D Printing Technology for masses in lesser amount of time.

 

 

The aim of this study is to explore the work-flow in manufacturing a Patient Specific Implant (PSI) in the shortest time with different software’s available in cases of facial fractures and to evaluate surgical outcome and surgical financial burden in patients treated with 3D Printing Technology assisted Surgery versus conventional surgery for facial fractures at Level 1 Trauma Centre, AIIMS, New Delhi.





 
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