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| ID | Type | Description | Link |
|---|---|---|---|
| NHG/RPR/04024 |
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| Name | Class |
|---|---|
| National Healthcare Group, Singapore | OTHER_GOV |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteosheet(r) | Device |
| Measure | Description | Time Frame |
|---|---|---|
| visual acuity | ||
| Enophthalmos | ||
| Diplopia | ||
| Cosmetic appearance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thiam-Chye Lim, MBBS, FRCS | National University Hospital, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Singapore | 119074 | Singapore |
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| ID | Term |
|---|---|
| D009917 | Orbital Fractures |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D019066 | Facies |
| ID | Term |
|---|---|
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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| D009422 |
| Nervous System Diseases |
| D012887 | Skull Fractures |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |