NCT00233922

Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Orbital Trauma
• Orbital Fractures

Interventions

Type	Name	Description
DEVICE	Osteosheet(r)

Timeline

• Start date: 2004-07-01
• Completion: 2007-07-01
• First posted: 2005-10-06
• Last updated: 2008-05-13

Locations

1 site across 1 country: Singapore