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
|
|
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
|
|
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
|
|
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.
|