Orbital Fractures, Orbital Trauma
Conditions
Keywords
orbit, orbital, trauma, fractures, facial
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.
Interventions
DEVICEOsteosheet(r)
Sponsors
National Healthcare Group, Singapore
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* age: 20 - 70 years facial trauma with orbital fractures
Exclusion criteria
* No other coexistent conditions eg. diabetes, heart disease, etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual acuity | — |
| Enophthalmos | — |
| Diplopia | — |
| Cosmetic appearance | — |
Countries
Singapore
Outcome results
None listed