Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant
- Conditions
- Orbital TraumaOrbital Fractures
- Registration Number
- NCT00233922
- Lead Sponsor
- National University Hospital, Singapore
- Brief Summary
Patients with orbital injuries are entered into the trial. Age: 20 - 70. After obtaining appropriate consent, they are entered into either a control arm where reconstruction of the orbit is done with a titanium mesh (established practice) or the experimental arm where reconstruction is by a bioresorbable implant made of polycaprolactone. Patients are followuped at 1 week, 1 month, 3 months, 6 months \& 12 months. CT scan of the orbits are performed preop, 6 months \& 12 months. End point is the 12 month follow-up appointment. Visual acuity, range of motion, enophthalmos \& diplopia are assessed in follow-up.
- Detailed Description
Patients with orbital injuries are entered into the trial. Age: 20 - 70. After obtaining appropriate consent, they are entered into either a control arm where reconstruction of the orbit is done with a titanium mesh (established practice) or the experimental arm where reconstruction is by a bioresorbable implant made of polycaprolactone. Patients are followuped at 1 week, 1 month, 3 months, 6 months \& 12 months. CT scan of the orbits are performed preop, 6 months \& 12 months. End point is the 12 month follow-up appointment. Visual acuity, range of motion, enophthalmos \& diplopia are assessed in follow-up.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- age: 20 - 70 years facial trauma with orbital fractures
- No other coexistent conditions eg. diabetes, heart disease, etc
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method visual acuity Enophthalmos Diplopia Cosmetic appearance
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National University Hospital
🇸🇬Singapore, Singapore