Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants (NCT01121159) | Clinical Trial Compass
CompletedNot Applicable
Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants
United States, Germany, Singapore185 participantsStarted 2010-06
Plain-language summary
Accuracy of posttraumatic orbital reconstruction of the medial orbital wall and/or floor is better with preoperatively preformed orbital implants than with non-preformed orbital implants.
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
. Patients ≥ 18 years
. Fracture (not older than 14 days) of the medial orbital wall and/or the orbital floor
. Scheduled for reconstruction surgery with one of the following implants:
. At least partial sight in both eyes before the accident
. Willingness and ability to participate in the study follow-up according to the protocol
. Ability to understand and read local language at elementary level
. Signed informed consent
Exclusion criteria
. Bilateral orbital fracture
. Fractures of the orbital roof
. Comminuted zygoma fracture
. More than one piece fracture of the intraorbital bone lateral to the inferior orbital fissure
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
1
shape and volume assessing software
Timeframe: up to 3 days after surgery
Trial details
NCT IDNCT01121159
SponsorAO Clinical Investigation and Publishing Documentation