Ignite Creation Date:
2024-05-06 @ 10:33 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03292679
Status:
WITHDRAWN
Last Update Posted:
2023-04-03
First Post:
2017-09-20
Brief Title:
Craniofacial Applications of 3D Printing
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Craniofacial Applications of 3D Printing
Status:
WITHDRAWN
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
There was lack of internal staff support and could not enroll participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
3D printing is a technology that allows for physical creation of a 3D model usually made of plastic based on computer generated 3D images from CT scans The 3D images of craniofacial skeleton using computer software are routinely generated and in turn these 3D images can be used to create a plastic 3D model using a 3D printer
Unstable or comminuted facial fractures need to be reduced and rigidly fixated using titanium plates and screws Bending and shaping of the plates is usually performed by free-hand based on the surgeons estimation of what best fits the fracture
Often bending the titanium plates to the shape of pre-injury skeletal contour is difficult when the bone is fractured into many pieces or is unstable or when the patient is edentulous missing several teeth The process can increase the time spent in surgery and the bent plates may not snugly fit the fracture For these difficult cases one option is to use commercially manufactured 3D printed patient-specific models The patient-specific models provide the benefit of correct shape form for increased surgical accuracy and decreased intra-operative time However these commercial models are manufactured at distant facilities and usually require more than 7 days before delivery As such they delay time to surgery and cannot be used for urgent surgery Additionally the commercially manufactured implants are expensive significantly increasing the cost of treatment
The purpose of this study is to explore whether custom plastic models 3D printed at Shock Trauma Center and used for bending and shaping plates for facial fracture repair can improve results of facial fracture reconstruction
Our plastic surgery division will design and produce facial bone 3D model of patients with facial fractures using an in-house 3D printer then use the 3D model to contour the hardware pre-op or intra-op at the time of fracture repair We believe that we can achieve better repair shorter surgery time and save hardware cost
Unstable or comminuted facial fractures need to be reduced and rigidly fixated using titanium plates and screws Bending and shaping of the plates is usually performed by free-hand based on the surgeons estimation of what best fits the fracture
Often bending the titanium plates to the shape of pre-injury skeletal contour is difficult when the bone is fractured into many pieces or is unstable or when the patient is edentulous missing several teeth The process can increase the time spent in surgery and the bent plates may not snugly fit the fracture For these difficult cases one option is to use commercially manufactured 3D printed patient-specific models The patient-specific models provide the benefit of correct shape form for increased surgical accuracy and decreased intra-operative time However these commercial models are manufactured at distant facilities and usually require more than 7 days before delivery As such they delay time to surgery and cannot be used for urgent surgery Additionally the commercially manufactured implants are expensive significantly increasing the cost of treatment
The purpose of this study is to explore whether custom plastic models 3D printed at Shock Trauma Center and used for bending and shaping plates for facial fracture repair can improve results of facial fracture reconstruction
Our plastic surgery division will design and produce facial bone 3D model of patients with facial fractures using an in-house 3D printer then use the 3D model to contour the hardware pre-op or intra-op at the time of fracture repair We believe that we can achieve better repair shorter surgery time and save hardware cost
Detailed Description:
The purpose of this study is to
1 produce 3D printed craniofacial models of patients with facial fracture then use the 3D models
2 contour or pre-bend the appropriate hardware pre-op that is specific for the patient
Fracture repair in the operating room entails exposure and reduction of the fracture followed by contouring the hardware to the correct shape to maintain the fracture reduction However in unstable or comminuted fractures or in patients missing several teeth contouring the plate to the correct shape can be time consuming and sometimes the plate shape can be inaccurate Our hypothesis is that using our own 3D model printed on-site to pre-bend plates will save intra-operative time and cost and achieve superior clinical outcome
Patients will be enrolled to participate if they meet inclusion and exclusion criteria and provide informed consent
Additionally for study subjects protected health information such as name date of birth medical record number and demographic information age sex ethnic group Billing and payment information with medical justification clinical information related to the procedure and follow-up visits will be handled by research personnel for research purposes
Otherwise management of the study subjects will be essentially the same as for patients that are not enrolled in the study This includes CT scans obtained postoperatively to confirm adequate fracture repair routine clinic follow-up visits during post-op week 1 week 4 3 months 6 months andor 1 year after surgery and additional follow-up visits as may be deemed necessary based on clinical status
Prior experience of utilizing on-site 3D printing technology in facial reconstruction surgery is limited If a patient-specific plate is needed then the plates must be made by commercial manufacturers which usually takes days to produce and is therefore not suited to treatment of facial trauma
Trauma plastic surgery division owns and operates a 3D printer We have experience with CT image processing and have made 3D models of patients facial skeleton ie midface mandible that were used as templates for repairing facial fractures
Patients with complex facial injuries or defects require reconstruction using hardware to restore facial contour and functional stability In many complex facial reconstructions surgeons consult commercial companies for expertise in computer aided design and manufacturing of patient-specific implants The advantages of undergoing this process include 1 in-depth anatomic analysis 2 improved design of hardware leading to better surgical outcome and 3 shortened OR time The disadvantages include length of time required for the production of patient-specific implant usually 3 to 7 days and high cost for example a mandible 3D model and associated patient-specific reconstruction plate is 3000
Three-dimensional printing is an actively evolving technology especially in surgery Design modifications and improvement in extrusion technology have made 3D printing made this process much more affordable and relatively easy It is now possible for individuals and surgeons to generate these 3D models
Repair of mandible fractures is especially challenging when the patient is edentulous missing several or all teeth for several reasons including the smaller bulk of the edentulous mandible requiring larger reconstructive plates spanning a bigger section of the jaw Surgery generally takes longer for these patients when compared with non-edentulous patients A substantial portion of the lengthiness is due to time spent bending the plate
The rationale for this IRB proposal is to explore the efficacy of 3D models of the patients fracture that are printed in house as aids for facial fracture reconstruction We hypothesize that reconstruction with the aid of the models will require shorter OR time improve bony fixation without significant increase in overall cost of treatment
1 produce 3D printed craniofacial models of patients with facial fracture then use the 3D models
2 contour or pre-bend the appropriate hardware pre-op that is specific for the patient
Fracture repair in the operating room entails exposure and reduction of the fracture followed by contouring the hardware to the correct shape to maintain the fracture reduction However in unstable or comminuted fractures or in patients missing several teeth contouring the plate to the correct shape can be time consuming and sometimes the plate shape can be inaccurate Our hypothesis is that using our own 3D model printed on-site to pre-bend plates will save intra-operative time and cost and achieve superior clinical outcome
Patients will be enrolled to participate if they meet inclusion and exclusion criteria and provide informed consent
Additionally for study subjects protected health information such as name date of birth medical record number and demographic information age sex ethnic group Billing and payment information with medical justification clinical information related to the procedure and follow-up visits will be handled by research personnel for research purposes
Otherwise management of the study subjects will be essentially the same as for patients that are not enrolled in the study This includes CT scans obtained postoperatively to confirm adequate fracture repair routine clinic follow-up visits during post-op week 1 week 4 3 months 6 months andor 1 year after surgery and additional follow-up visits as may be deemed necessary based on clinical status
Prior experience of utilizing on-site 3D printing technology in facial reconstruction surgery is limited If a patient-specific plate is needed then the plates must be made by commercial manufacturers which usually takes days to produce and is therefore not suited to treatment of facial trauma
Trauma plastic surgery division owns and operates a 3D printer We have experience with CT image processing and have made 3D models of patients facial skeleton ie midface mandible that were used as templates for repairing facial fractures
Patients with complex facial injuries or defects require reconstruction using hardware to restore facial contour and functional stability In many complex facial reconstructions surgeons consult commercial companies for expertise in computer aided design and manufacturing of patient-specific implants The advantages of undergoing this process include 1 in-depth anatomic analysis 2 improved design of hardware leading to better surgical outcome and 3 shortened OR time The disadvantages include length of time required for the production of patient-specific implant usually 3 to 7 days and high cost for example a mandible 3D model and associated patient-specific reconstruction plate is 3000
Three-dimensional printing is an actively evolving technology especially in surgery Design modifications and improvement in extrusion technology have made 3D printing made this process much more affordable and relatively easy It is now possible for individuals and surgeons to generate these 3D models
Repair of mandible fractures is especially challenging when the patient is edentulous missing several or all teeth for several reasons including the smaller bulk of the edentulous mandible requiring larger reconstructive plates spanning a bigger section of the jaw Surgery generally takes longer for these patients when compared with non-edentulous patients A substantial portion of the lengthiness is due to time spent bending the plate
The rationale for this IRB proposal is to explore the efficacy of 3D models of the patients fracture that are printed in house as aids for facial fracture reconstruction We hypothesize that reconstruction with the aid of the models will require shorter OR time improve bony fixation without significant increase in overall cost of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None