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| Sponsors and Collaborators: |
National University Hospital, Singapore National Healthcare Group, Singapore |
|---|---|
| Information provided by: | National University Hospital, Singapore |
| ClinicalTrials.gov Identifier: | NCT00233922 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Orbital Trauma Orbital Fractures |
Device: Osteosheet(r) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-equivalence Study |
| Official Title: | Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant |
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2004 |
| Study Completion Date: | July 2007 |
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.
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Singapore | |
| National University Hospital | |
| Singapore, Singapore, 119074 | |
| Principal Investigator: | Thiam-Chye Lim, MBBS, FRCS | National University Hospital, Singapore |
More Information
| Responsible Party: | National University Hospital, Singapore ( Thiam-Chye Lim, MBBS, FRCS ) |
| Study ID Numbers: | NHG/RPR/04024, NHG/RPR/04024 |
| Study First Received: | October 5, 2005 |
| Last Updated: | May 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00233922 |
| Health Authority: | Singapore: Health Sciences Authority |
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orbit orbital trauma fractures facial |
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Craniocerebral Trauma Facial Injuries Facies Fractures, Bone |
Maxillofacial Injuries Wounds and Injuries Disorders of Environmental Origin Orbital Fractures |
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Skull Fractures |
