Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant

National University Health System (NUHS)

Status and phase: Completed; Phase 2

Conditions: Orbital Trauma; Orbital Fractures

Treatments: Device: Osteosheet(r)

Study type: Interventional

Funder types: Other

Identifiers

NCT00233922

NHG/RPR/04024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age: 20 - 70 years facial trauma with orbital fractures

Exclusion criteria

• No other coexistent conditions eg. diabetes, heart disease, etc

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)