<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03292679</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00071854</org_study_id>
    <nct_id>NCT03292679</nct_id>
  </id_info>
  <brief_title>Craniofacial Applications of 3D Printing</brief_title>
  <official_title>Craniofacial Applications of 3D Printing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      3D printing is a technology that allows for physical creation of a 3D model (usually made of&#xD;
      plastic) based on computer generated 3D images from CT scans. The 3D images of craniofacial&#xD;
      skeleton using computer software are routinely generated and, in turn, these 3D images can be&#xD;
      used to create a plastic 3D model using a 3D printer.&#xD;
&#xD;
      Unstable or comminuted facial fractures need to be reduced and rigidly fixated using titanium&#xD;
      plates and screws. Bending and shaping of the plates is usually performed by free-hand based&#xD;
      on the surgeon's estimation of what best fits the fracture.&#xD;
&#xD;
      Often, bending the titanium plates to the shape of pre-injury skeletal contour is difficult&#xD;
      when the bone is fractured into many pieces or is unstable, or when the patient is edentulous&#xD;
      (missing several teeth). The process can increase the time spent in surgery and the bent&#xD;
      plates may not snugly fit the fracture. For these difficult cases, one option is to use&#xD;
      commercially manufactured 3D printed patient-specific models. The patient-specific models&#xD;
      provide the benefit of correct shape / form for increased surgical accuracy, and decreased&#xD;
      intra-operative time. However these commercial models are manufactured at distant facilities&#xD;
      and usually require more than 7 days before delivery. As such, they delay time to surgery and&#xD;
      cannot be used for urgent surgery. Additionally, the commercially manufactured implants are&#xD;
      expensive, significantly increasing the cost of treatment.&#xD;
&#xD;
      The purpose of this study is to explore whether custom plastic models 3D printed at Shock&#xD;
      Trauma Center and used for bending and shaping plates for facial fracture repair can improve&#xD;
      results of facial fracture reconstruction.&#xD;
&#xD;
      Our plastic surgery division will design and produce facial bone 3D model of patients (with&#xD;
      facial fractures) using an in-house 3D printer, then use the 3D model to contour the hardware&#xD;
      pre-op or intra-op at the time of fracture repair. We believe that we can achieve better&#xD;
      repair, shorter surgery time, and save hardware cost.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to:&#xD;
&#xD;
        1. produce 3D printed craniofacial models of patients with facial fracture, then use the 3D&#xD;
           models&#xD;
&#xD;
        2. contour (or pre-bend) the appropriate hardware pre-op that is specific for the patient.&#xD;
&#xD;
      Fracture repair in the operating room entails exposure and reduction of the fracture,&#xD;
      followed by contouring the hardware to the correct shape to maintain the fracture reduction.&#xD;
      However, in unstable or comminuted fractures or in patients missing several teeth, contouring&#xD;
      the plate to the correct shape can be time consuming and, sometimes, the plate shape can be&#xD;
      inaccurate. Our hypothesis is that using our own 3D model printed on-site to &quot;pre-bend&quot;&#xD;
      plates will save intra-operative time and cost, and achieve superior clinical outcome.&#xD;
&#xD;
      Patients will be enrolled to participate if they meet inclusion and exclusion criteria, and&#xD;
      provide informed consent.&#xD;
&#xD;
      Additionally, for study subjects, protected health information such as name, date of birth,&#xD;
      medical record number, and demographic information (age, sex, ethnic group), Billing and&#xD;
      payment information with medical justification, clinical information related to the procedure&#xD;
      and follow-up visits will be handled by research personnel for research purposes.&#xD;
&#xD;
      Otherwise, management of the study subjects will be essentially the same as for patients that&#xD;
      are not enrolled in the study. This includes CT scans obtained postoperatively to confirm&#xD;
      adequate fracture repair, routine clinic follow-up visits (during post-op week 1, week 4, 3&#xD;
      months, 6 months, and/or 1 year after surgery) and additional follow-up visits as may be&#xD;
      deemed necessary based on clinical status.&#xD;
&#xD;
      Prior experience of utilizing on-site 3D printing technology in facial reconstruction surgery&#xD;
      is limited. If a patient-specific plate is needed, then the plates must be made by commercial&#xD;
      manufacturers which usually takes days to produce, and is therefore not suited to treatment&#xD;
      of facial trauma.&#xD;
&#xD;
      Trauma plastic surgery division owns and operates a 3D printer. We have experience with CT&#xD;
      image processing and have made 3D models of patients facial skeleton (i.e. midface, mandible)&#xD;
      that were used as templates for repairing facial fractures.&#xD;
&#xD;
      Patients with complex facial injuries or defects require reconstruction using hardware to&#xD;
      restore facial contour and functional stability. In many complex facial reconstructions,&#xD;
      surgeons consult commercial companies for expertise in computer aided design and&#xD;
      manufacturing of patient-specific implants. The advantages of undergoing this process include&#xD;
      (1) in-depth anatomic analysis, (2) improved design of hardware leading to better surgical&#xD;
      outcome, and (3) shortened OR time. The disadvantages include length of time required for the&#xD;
      production of patient-specific implant (usually 3 to 7 days), and high cost: for example, a&#xD;
      mandible 3D model and associated patient-specific reconstruction plate is &gt;$3000.&#xD;
&#xD;
      Three-dimensional printing is an actively evolving technology, especially in surgery. Design&#xD;
      modifications and improvement in extrusion technology have made 3D printing made this process&#xD;
      much more affordable and relatively easy. It is now possible for individuals (and surgeons!)&#xD;
      to generate these 3D models.&#xD;
&#xD;
      Repair of mandible fractures is especially challenging when the patient is edentulous&#xD;
      (missing several or all teeth) for several reasons including the smaller bulk of the&#xD;
      edentulous mandible, requiring larger reconstructive plates spanning a bigger section of the&#xD;
      jaw. Surgery generally takes longer for these patients when compared with non-edentulous&#xD;
      patients. A substantial portion of the lengthiness is due to time spent bending the plate.&#xD;
&#xD;
      The rationale for this IRB proposal is to explore the efficacy of 3D models of the patient's&#xD;
      fracture that are printed in house as aids for facial fracture reconstruction. We hypothesize&#xD;
      that reconstruction with the aid of the models will require shorter OR time, improve bony&#xD;
      fixation, without significant increase in overall cost of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    There was lack of internal staff support and could not enroll participants.&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 2019</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Operative time</measure>
    <time_frame>24 hours</time_frame>
    <description>Duration of fracture fixation</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Facial Fracture</condition>
  <arm_group>
    <arm_group_label>3D template</arm_group_label>
    <description>Subjects will have custom models of relevant portions of their facial skeleton printed and used as templates for bending and shaping plates for stabilizing the fracture(s).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>3D template</intervention_name>
    <description>A 3D-printed model of relevant portions of the patient's facial skeleton, based on patient's CT scan will be created. This model will be used to bend titanium reconstruction plates that are used to stabilize the facial fracture for subjects in the treatment group.&#xD;
Bending of the plates will be performed in the operating room during the patient's surgery. Titanium reconstruction plates are used to stabilize the fracture whether or not the individual is in the study. However, for patients that are in the treatment arm of the study, the plates are bent with the aid of the 3D-printed model as template, rather than by free-hand.</description>
    <arm_group_label>3D template</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting to Shock Trauma Plastic Surgery Division for treatment of facial&#xD;
        fractures&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with face CT scans&#xD;
&#xD;
          -  Patients with facial fractures&#xD;
&#xD;
          -  Patient age 12 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without CT scan&#xD;
&#xD;
          -  Patients with facial fractures that do not require rigid fixation using hardware&#xD;
&#xD;
          -  Patients with facial fractures that do not have normal contralateral bony structures&#xD;
&#xD;
          -  Patient age less than 12 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Arthur J Nam</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>March 31, 2023</last_update_submitted>
  <last_update_submitted_qc>March 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Arthur Nam</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03292679
org study id: HP-00071854
nct id: NCT03292679
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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 surgeon's 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.
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, and/or 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 (i.e. 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 patient's
      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.
observational model: Cohort
time perspective: Prospective
measure: Operative time
time frame: 24 hours
description: Duration of fracture fixation
arm group label: 3D template
description: Subjects will have custom models of relevant portions of their facial skeleton printed and used as templates for bending and shaping plates for stabilizing the fracture(s).
intervention type: Procedure
intervention name: 3D template
description: A 3D-printed model of relevant portions of the patient's facial skeleton, based on patient's CT scan will be created. This model will be used to bend titanium reconstruction plates that are used to stabilize the facial fracture for subjects in the treatment group.
Bending of the plates will be performed in the operating room during the patient's surgery. Titanium reconstruction plates are used to stabilize the fracture whether or not the individual is in the study. However, for patients that are in the treatment arm of the study, the plates are bent with the aid of the 3D-printed model as template, rather than by free-hand.
arm group label: 3D template
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Arthur Nam
investigator title: Assistant Professor