Orbital FracturesNCT03673865
The Use of 3D Printing in Orbital Fractures
A study testing office-based 3-dimensional printers (OB3DP) and standard stock orbital plate in people with Orbital Fractures, run by Emory University at 1 site in United States.
Trial summary
The study is a prospective randomized longitudinal clinical study to compare pre-adapted patient-specific orbital implants utilizing an office-based 3-D printer versus standard non-adapted orbital implants (the latter being the traditional approach and current standard of care). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orbital Fractures
- What is being tested?
- office-based 3-dimensional printers (OB3DP) and standard stock orbital plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2019to 10 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agreed to be enrolled in the study.
- Indications for surgical repair of orbital floor and/ wall fractures are dependent on several factors:
- Correction or prevention of cosmetic deformity ( enophthalmos or inferior dystopia; disruption of greater than 50% of the orbital floor is likely to cause cosmetically apparent enophthalmos.
- Correction of unresolved diplopia (7 to 11 days) in the sitting of soft tissue prolapse with a positive forced duction test.
- Immediate correction of diplopia in the sitting inferior rectus muscle incarceration and a positive forced duction test.
- Immediate correction in a symptomatic patient with orbital floor ( trapdoor) fracture that has elicited the oculocardiac reflex.
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- At least 18 years of age.
- Unilateral orbital floor fracture.
- No history of orbital trauma.
- Healthy contralateral orbit.
- Underwent orbital reconstruction.
- Admitted to GMH.
- Returned for the 6-week follow-up.
Who cannot join
- Refuse study enrollment.
- Are younger than 18 years.
- Pregnant women.
- Prisoner
- Unable to obtain consent (cognitively impaired)
- Are admitted to hospitals other than Grady Memorial Hospital.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Use of a Customized Titanium Reconstruction Plate for Orbital Fractures Result in Better Orbital Volume and Outcome
The study is a prospective randomized longitudinal clinical study to compare pre-adapted patient-specific orbital implants utilizing an office-based 3-D printer versus standard non-adapted orbital implants (the latter being the traditional approach and current standard of care).
Read the detailed description
Orbital fracture, which accounts for 10-25% of facial fractures, is one of the most difficult facial fractures to treat. The complex bone anatomy and the proximity of adjacent vital structures make reconstruction of these fractures challenging. Inadequate orbital fracture reconstruction leads to cosmetic and functional complications. Cosmetic complications include enophthalmos, which is defined as posterior displacement of the eyeball within the orbit due to changes in the volume of the orbit (bone) relative to its contents (the eyeball and orbital fat). Functional complications include diplopia, defined as a type of vision disorder in which two images are seen of a single object.
This is a prospective randomized clinical study with longitudinal follow-up. The study duration is 2 years, and it will be conducted at Grady Memorial Hospital (GMH). The study targets low-income, urban adults suffering blunt facial trauma who are diagnosed with unilateral orbital fracture.
The purpose of this study is to compare pre-adapted patient-specific orbital implants utilizing an office-based 3-D printer versus standard non-adapted orbital implants. Main aims of the study are to 1) preoperatively generate a patient-specific model to pre-adapt the titanium mesh for use in unilateral orbital fractures; 2) accurately restore the orbital volume to pre-injury levels; 3) prevent postoperative complications including enophthalmos and diplopia; and 4) decrease the operative time, therefore decreasing overall cost and increasing value.
- Conditions
- Orbital Fractures
- Being tested
- office-based 3-dimensional printers (OB3DP), standard stock orbital plate
- Keywords
- 3D Printer, orbital implants
- Medical subject headings
- Orbital Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
office-based 3-dimensional printers (OB3DP)Device
Also called 3D Printer, Prusa i3 MK2 3D Printer kit with liquid crystal display
In this treatment group subjects, using office-based 3-dimensional printers (OB3DP) a patient-specific pre-adjusted (pre-bend) orbital plates will be made using over-the-counter titanium plates that are manually adjusted according to the printed model. The plates are then send to sterilization for preparation.
standard stock orbital plateDevice
Also called orbital plate
In this control group subjects will receive non-patient-specific orbital implants which is standard stock orbital plate that is adapted intraoperatively to the fractured orbit
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Patients undergo orbital reconstruction using pre-adjusted patient-specific orbital implants with office-based 3-dimensional printers (OB3DP) Receives: Device: office-based 3-dimensional printers (OB3DP) |
| Control Group | Active comparator | Patients undergo orbital reconstruction with non-patient-specific orbital implants (traditional approach, Control Group) which is a standard stock orbital plate Receives: Device: standard stock orbital plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orbital Volume of the Injured Orbit Compared to the Contralateral Uninjured Orbit as Assessed by CT Scan Between the Treatment and Control Groups
The Primary Investigator will evaluate the orbital volume using OsiriX (medical software). Orbital volume measurements will be obtained to compare the injured and uninjured (contralateral) orbital volumes. OsiriX MD offers advanced processing techniques and has the ability to precisely measure orbital volume. It also utilizes the DICOM data from the immediate postoperative CT scans.
Measured: 1 hour post operatively
Secondary outcomes (10)
Number of Subjects With Reduction of Orbital Volume to Less Than 2 cm3 Between the Treatment and Control Groups
Adequate orbital volume reduction, defined as a reduction of orbital volume to less than 2 cm3. The Primary Investigator will evaluate the orbital volume using OsiriX (medical software). Number of subjects with reduction of orbital volume to less than 2 cm3 between the treatment and control groups are recorded
Measured: 1 week, 3 weeks, and 6 weeks postoperatively.
Number of Subjects With a Difference of More Than 2 mm Between the Two Orbits Between the Treatment and Control Groups
A difference of more than 2 mm between the two orbits is diagnostic for enophthalmos. Enophthalmos is assessed by clinical examination using a Hertel exophthalmometer. The measurement is taken from the lateral orbital rim to the corneal apex. The normal range is 12-21 mm. Upper normal limit for people of African origin is a little higher, about 23-24 mm. A difference greater than 2 mm between the eyes is significant.
Measured: 1 week, 3 weeks, and 6 weeks postoperatively.
Number of Subjects With Infection Between the Treatment and Control Groups
Infection is defined by the presence of postoperative pus in the wound, a sinus tract or fistula, or elevated white blood cell count (WBC) >11.0x109/L combined with erythematous skin and swelling on the operated side more than on the un-operated side. WBC is measured with a blood draw test. Infection will be confirmed with clinical examination along with blood tests.
Measured: 1 week, 3 weeks, and 6 weeks postoperatively.
Number of Subjects With Infraorbital Nerve Injury Between the Treatment and Control Groups
Infraorbital nerve injury is assessed by clinical examination using neurosensory testing (NST). NST is a standardized methodology designed to objectively evaluate sensory nerve function. The sensory impairment is determined by 3 levels of testing; each level classifies a specific type of sensory nerve injury.
Measured: 1 week, 3 weeks, and 6 weeks postoperatively.
Number of Subjects With Intraocular Pressure (IOP) > 40 mmHg Between the Treatment and Control Groups
Intraocular pressure (IOP) > 40 mmHg is diagnostic of orbital compartment syndrome. Orbital compartment syndrome is assessed through clinical examination using tonometry test. Tonometry is a diagnostic test that measures the pressure inside your eye, which is called intraocular pressure (IOP). The normal pressure range is 12 to 22 mm Hg.
Measured: 1 week, 3 weeks, and 6 weeks postoperatively.
Mean Operating Time in Minutes Between the Treatment and Control Groups
Operating time will be calculated from fracture exposure and identification to the final implant placement and fixation and will be recorded in minutes. This will be compared between the two treatment groups. To record and compare the operative time between the two groups, a stopwatch will be utilized.
Measured: Intraoperative time period
Mean Length of Stay in Hospital Measured in Days Between the Treatment and Control Groups
Isolated orbital floor fracture patients do not require a pre-operative hospital stay. Length of stay will be calculated in terms of postoperative hospital stay (days). Length of stay in cases of complex orbital fracture will be calculated in terms of pre-operative and postoperative hospital stay (days). The number of days subject stays in the hospital are measured and compared
Measured: up to 2 weeks
Mean Treatment Amount in Dollars Between the Treatment and Control Groups
Treatment charges will be calculated with consideration of the following:
- Facility operating room charges, which include anesthesia time (surgical time multiplied by the facility rate of $33/ minute).
- Hardware charges (plates and screws).
- Length Of Stay charges (LOS multiplied by the facility daily rate of $1,690/ day).
- The cost of the 3D printed model including the cost of the 3D printer and filaments ($1.5).
All treatment charge variables will be provided by the Grady Memorial Hospital Financial Planning and Analysis center. Total treatment charges facility operating room charges, hardware charges, LOS, and the 3D printed model cost will be compared between groups in a manner similar to that outlined in previous studies by our group.
Measured: up to 2 weeks
Number of Subjects That Develop Restricted Extraocular Motility That Was Not Present Before Between the Treatment and Control Groups
Extra-ocular motility is assessed through clinical examination. The patient should be able to move the eyes through the six cardinal positions of gaze (left, right, up and right, up and left, down and right, down and left). All patients will be examined for the following:
- Development of restricted extraocular motility that was not present prior to the surgery.
- Persistent restriction of extraocular motility after the surgery
Measured: 1 week, 3 weeks, and 6 weeks postoperatively.
Number of Subjects With Inability to Achieve the Normal Orbital Contour Between the Treatment and Control Groups
Inability to achieve the normal orbital contour as assessed in the immediate post-operative Computerized Tomography (CT) scan. Maxillofacial non-contrast CT scans according to the protocol will be obtained as part of the standard of care in managing orbital fractures and will be obtained for all subjects post operatively.
Measured: Up to 6 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start11 Oct 2019
- Primary completion10 Jun 2021
- Study completion10 Jun 2021
Why it stopped: Enrollment and study activities were initially suspended due to COVID-19 and it has been determined that the study will not resume.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Orbital FracturesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective randomized clinical study with longitudinal follow-up
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Amin, Emory University
- Investigators
- Dina Amin, DDS, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673865
- Sponsor's protocol ID
- IRB00103655
- Status last verified
- Jul 2022
- First submitted
- 14 Sep 2018
- Last updated
- 27 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of a Customized Titanium Reconstruction Plate for Orbital Fractures Result in Better Orbital Volume and Outcome
- ClinicalTrials.gov ID
- NCT03673865
- Acronym / sponsor ID
- IRB00103655
- Conditions
- Orbital Fractures
- Keywords
- 3D Printer, orbital implants
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment and study activities were initially suspended due to COVID-19 and it has been determined that the study will not resume.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Posted 27 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a prospective randomized longitudinal clinical study to compare pre-adapted patient-specific orbital implants utilizing an office-based 3-D printer versus standard non-adapted orbital implants (the latter being the traditional approach and current standard of care).
Detailed description
Orbital fracture, which accounts for 10-25% of facial fractures, is one of the most difficult facial fractures to treat. The complex bone anatomy and the proximity of adjacent vital structures make reconstruction of these fractures challenging. Inadequate orbital fracture reconstruction leads to cosmetic and functional complications. Cosmetic complications include enophthalmos, which is defined as posterior displacement of the eyeball within the orbit due to changes in the volume of the orbit (bone) relative to its contents (the eyeball and orbital fat). Functional complications include diplopia, defined as a type of vision disorder in which two images are seen of a single object.
This is a prospective randomized clinical study with longitudinal follow-up. The study duration is 2 years, and it will be conducted at Grady Memorial Hospital (GMH). The study targets low-income, urban adults suffering blunt facial trauma who are diagnosed with unilateral orbital fracture.
The purpose of this study is to compare pre-adapted patient-specific orbital implants utilizing an office-based 3-D printer versus standard non-adapted orbital implants. Main aims of the study are to 1) preoperatively generate a patient-specific model to pre-adapt the titanium mesh for use in unilateral orbital fractures; 2) accurately restore the orbital volume to pre-injury levels; 3) prevent postoperative complications including enophthalmos and diplopia; and 4) decrease the operative time, therefore decreasing overall cost and increasing value.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective randomized clinical study with longitudinal follow-up
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: office-based 3-dimensional printers (OB3DP)Patients undergo orbital reconstruction using pre-adjusted patient-specific orbital implants with office-based 3-dimensional printers (OB3DP) |
| Control Group | Active comparator | Device: standard stock orbital platePatients undergo orbital reconstruction with non-patient-specific orbital implants (traditional approach, Control Group) which is a standard stock orbital plate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Agreed to be enrolled in the study.
- Indications for surgical repair of orbital floor and/ wall fractures are dependent on several factors:
- At least 18 years of age.
- Unilateral orbital floor fracture.
- No history of orbital trauma.
Key exclusion criteria (6 listed)
- Refuse study enrollment.
- Are younger than 18 years.
- Pregnant women.
- Prisoner
- Unable to obtain consent (cognitively impaired)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| office-based 3-dimensional printers (OB3DP)Also: 3D Printer, Prusa i3 MK2 3D Printer kit with liquid crystal displayIn this treatment group subjects, using office-based 3-dimensional printers (OB3DP) a patient-specific pre-adjusted (pre-bend) orbital plates will be made using over-the-counter titanium plates that are manually adjusted according to the printed model. The plates are then send to sterilization for preparation. | Device | Treatment Group |
| standard stock orbital plateAlso: orbital plateIn this control group subjects will receive non-patient-specific orbital implants which is standard stock orbital plate that is adapted intraoperatively to the fractured orbit | Device | Control Group |
Primary outcome
Orbital Volume of the Injured Orbit Compared to the Contralateral Uninjured Orbit as Assessed by CT Scan Between the Treatment and Control Groups
Time frame: 1 hour post operatively
The Primary Investigator will evaluate the orbital volume using OsiriX (medical software). Orbital volume measurements will be obtained to compare the injured and uninjured (contralateral) orbital volumes. OsiriX MD offers advanced processing techniques and has the ability to precisely measure orbital volume. It also utilizes the DICOM data from the immediate postoperative CT scans.
10 secondary outcomes
Number of Subjects With Reduction of Orbital Volume to Less Than 2 cm3 Between the Treatment and Control Groups
Time frame: 1 week, 3 weeks, and 6 weeks postoperatively.
Number of Subjects With a Difference of More Than 2 mm Between the Two Orbits Between the Treatment and Control Groups
Time frame: 1 week, 3 weeks, and 6 weeks postoperatively.
Number of Subjects With Infection Between the Treatment and Control Groups
Time frame: 1 week, 3 weeks, and 6 weeks postoperatively.
Number of Subjects With Infraorbital Nerve Injury Between the Treatment and Control Groups
Time frame: 1 week, 3 weeks, and 6 weeks postoperatively.
Number of Subjects With Intraocular Pressure (IOP) > 40 mmHg Between the Treatment and Control Groups
Time frame: 1 week, 3 weeks, and 6 weeks postoperatively.
Mean Operating Time in Minutes Between the Treatment and Control Groups
Time frame: Intraoperative time period
Mean Length of Stay in Hospital Measured in Days Between the Treatment and Control Groups
Time frame: up to 2 weeks
Mean Treatment Amount in Dollars Between the Treatment and Control Groups
Time frame: up to 2 weeks
Number of Subjects That Develop Restricted Extraocular Motility That Was Not Present Before Between the Treatment and Control Groups
Time frame: 1 week, 3 weeks, and 6 weeks postoperatively.
Number of Subjects With Inability to Achieve the Normal Orbital Contour Between the Treatment and Control Groups
Time frame: Up to 6 hours postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Orbital Fractures
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Epidemiological and Statistical Study of Facial Traumatic Fractures at Assiut University Trauma Hospital
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A Trial to Evaluate Two Ectropion Preventive Measures Using the Subciliary Approach in Orbital Fracture Surgery.
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Orbital Fractures Registry
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dina Amin, DDS principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing office-based 3-dimensional printers (OB3DP) and standard stock orbital plate in people with Orbital Fractures, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orbital Volume of the Injured Orbit Compared to the Contralateral Uninjured Orbit as Assessed by CT Scan Between the Treatment and Control Groups (time frame: 1 hour post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.