Polycaprolactone / Tricalcium Phosphate (PCL/TCP) v Titanium Orbital Implant : Randomised Trial (NCT01119144) | Clinical Trial Compass
UnknownPhase 2
Polycaprolactone / Tricalcium Phosphate (PCL/TCP) v Titanium Orbital Implant : Randomised Trial
Singapore80 participantsStarted 2010-04
Plain-language summary
Hypothesis: Polycaprolactone / Tricalcium Phosphate Orbital (PCL / TCP) Implant is as effective in the reconstruction of the Orbital walls as Titanium Mesh implant.
In this study we will be conducting a randomised trial to compare implants made of 2 materials for Orbital reconstruction
* Polycaprolactone / Tricalcium Phosphate (PCL / TCP)
* Titanium
Patients to be recruited :
* 80 randomised equally into the 2 groups
* age range: 21 - 70
* includes orbital wall defects from trauma, after osteotomies
* excludes patients with Diabetes Mellitus, known allergies to polycaprolactone \& its analogues, know allergies to Tricalcium Phosphate \& its analogues, infections generalised \& around the orbital region
Trial Duration: April 2010 - March 2015
Follow up:
* postoperative 1 week, 1 month, 3 months, 6 months, and 12 months
* Computer Tomographic (CT) scan of Orbits immediate postoperative and at 12 months appointment
Who can participate
Age range
21 Years – 70 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:
* age 21 y - 70 y
* both males / females included
* orbital fractures
* defect after orbital osteotomies
Exclusion Criteria:
* patient refusal
* infection around the orbit / generalised infection
* Diabetes mellitus
* allergies to polycaprolactone \& its analogues
* allergies to titanium
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.