The Use of 3D Printing in Orbital Fractures

NCT03673865 | Terminated Results DMC FDA Device

• 1 other identifier: IRB00103655
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Orbital Fractures

Keywords

3D Printer; orbital implants

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  1 week, 3 weeks, and 6 weeks postoperatively.

• Number of Subjects With Infection Between the Treatment and Control Groups

  1 week, 3 weeks, and 6 weeks postoperatively.

• Number of Subjects With Infraorbital Nerve Injury Between the Treatment and Control Groups

  1 week, 3 weeks, and 6 weeks postoperatively.

• Number of Subjects With Intraocular Pressure (IOP) > 40 mmHg Between the Treatment and Control Groups

  1 week, 3 weeks, and 6 weeks postoperatively.

Study Arms (2)

Treatment Group

EXPERIMENTAL

Patients undergo orbital reconstruction using pre-adjusted patient-specific orbital implants with office-based 3-dimensional printers (OB3DP)

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

Device: standard stock orbital plate

Interventions

office-based 3-dimensional printers (OB3DP) DEVICE

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.

Also known as: 3D Printer, Prusa i3 MK2 3D Printer kit with liquid crystal display

Treatment Group

standard stock orbital plate DEVICE

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

Also known as: orbital plate

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Orbital Fractures

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Results Point of Contact

• Title: Dina Amin
• Organization: Emory University

dina.amin@emory.edu

404-251-8895

Study Officials

• Dina Amin, DDS

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a prospective randomized clinical study with longitudinal follow-up

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 17, 2018
• Study Start: October 11, 2019
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: July 27, 2022
• Results First Posted: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)