TerminatedNot Applicable

The Use of 3D Printing in Orbital Fractures

Stopped: Enrollment and study activities were initially suspended due to COVID-19 and it has been determined that the study will not resume.

United States25 participantsStarted 2019-10-11

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Orbital Volume of the Injured Orbit Compared to the Contralateral Uninjured Orbit as Assessed by CT Scan Between the Treatment and Control Groups

Timeframe: 1 hour post operatively

Trial details

NCT IDNCT03673865

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-10

Results submitted2022-05-04

View on ClinicalTrials.gov More Orbital Fractures trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.