3D Printing applications for reconstruction of facial defects
- Conditions
- Unspecified pedal cyclist injuredin collision with other and unspecified motor vehicles in traffic accident,
- Registration Number
- CTRI/2018/10/016039
- Lead Sponsor
- All India Institute of Medical SciencesNew Delhi
- Brief Summary
Reconstruction of maxillofacial defects has alwaysbeen a challenging task for the scientist and surgeons over the years. The maingoal of the reconstruction of the maxillofacial region is to restore facialform, function, full rehabilitation of occlusion and articulation [1].Autogenousbone grafts are still considered the gold standard for reconstructive bonesurgery [2]. However, donor site morbidity and limited availability are ofconcern [3].Reconstructive Surgery is evolving into a multidisciplinary fieldwhere surgeon needs to work with scientist and engineers to develop alternativeapproaches to decrease side effects associated with surgery. Elimination ofsurgery is unrealistic but newer technologies may reduce number of proceduresand improve outcome of surgery.
Additive Manufacturing, aprocess of joining materials to build objects, was invented in 1980 but itsgreatest momentum has been in the 21st century due to itsaccessibility to different sectors including healthcare. The term Stereo lithographywas coined in 1986 by Chuck Hull, who patented creating 3D objects bydepositing thin layers and curing with ultraviolet light, starting from bottomto top.3D technology ranges from contour models, guides, splints and PatientSpecific Implants. The application of this technology has grown across sectorsin industry while in medicine it has grown from diagnosis and educationalmodels to medical devices and surgical applications of patient specific data. Themost common medical modelling software is Mimics and the most common printingsoftware being 3D Systems. Patient specific implants have superior anatomicalmatching and can be custom designed as per the defect. The 3-D Technologieshold great potential in improving surgical outcome in terms of form, function,finances and time-frame. We therefore have a scope to identify the evidence forimprovements in the surgical outcome by incorporation of 3D technologies intoroutine surgeries. Presently, lack of high level evidence remains a barrier toassessing the effectiveness of the technology, therefore opening futureresearch opportunities. Other barriers to the incorporation of 3D PrintingTechnologies include little awareness among surgeons about the technologicalaspect, high cost of the modelling and printing software along with costinvolved file conversions, cost of materials to be used, additional time takenfor the entire process and lack of infrastructure. A hospital based 3D PrintingTechnology laboratory can positively decrease cost of Patient Specific Implants(PSI) and enhance surgical outcome while incorporating 3D Printing Technologyfor masses in lesser amount of time.
The aim of this study is to explore the work-flow inmanufacturing a Patient Specific Implant (PSI) in the shortest time withdifferent software’s available in cases of facial fractures and to evaluatesurgical outcome and surgical financialburden in patients treated with 3D Printing Technology assisted Surgery versusconventional surgery for facial fractures at Level 1 Trauma Centre, AIIMS, NewDelhi.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 10
1.Both male and females , 2.Age:18-65 years 3.GCS> 13 4.Secondary facial deformities.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method decreased surgicaltime decrease number of surgeries(while planning pre op) | improved quality of life(pre op,3,6mons) | decreased surgicaltime(at time of surgery) decrease number of surgeries decrease number of surgeries(while planning pre op) | improved quality of life(pre op,3,6mons) | decreased surgicaltime(at time of surgery) improved quality of life decrease number of surgeries(while planning pre op) | improved quality of life(pre op,3,6mons) | decreased surgicaltime(at time of surgery)
- Secondary Outcome Measures
Name Time Method less financial implications better accuracy
Trial Locations
- Locations (1)
JPN Apex Trauma Centre AIIMS New Delhi
🇮🇳Delhi, DELHI, India
JPN Apex Trauma Centre AIIMS New Delhi🇮🇳Delhi, DELHI, IndiaDr Ruchi Pathak KaulPrincipal investigator9650777017ruchi8380@gmail.com