polycaprolactone / tricalcium phosphate (pcl/tcp) v titanium orbital implant : randomised trial

Conditions: Fractures; Enophthalmos; Diplopia

Summary: hypothesis: polycaprolactone / tricalcium phosphate orbital (pcl / tcp) implant is as effective in the reconstruction of the orbital walls as titanium mesh implant. in this study we will be conducting a randomised trial to compare implants made of 2 materials for orbital reconstruction * polycaprolactone / tricalcium phosphate (pcl / tcp) * titanium patients to be recruited : * 80 randomised equally into the 2 groups * age range: 21 - 70 * includes orbital wall defects from trauma, after osteotomies * excludes patients with diabetes mellitus, known allergies to polycaprolactone \& its analogues, know allergies to tricalcium phosphate \& its analogues, infections generalised \& around the orbital region trial duration: april 2010 - march 2015 follow up: * postoperative 1 week, 1 month, 3 months, 6 months, and 12 months * computer tomographic (ct) scan of orbits immediate postoperative and at 12 months appointment

hypothesis: polycaprolactone / tricalcium phosphate (pcl / tcp) orbital implant is as effective in the reconstruction of the orbital walls as titanium mesh in this study we will be conducting a randomised trial to compare implants made of 2 materials for orbital reconstruction * polycaprolactone / tricalcium phosphate (pcl / tcp) * titanium patients to be recruited : * 80 randomised equally into the 2 groups * age range: 21 -70 * includes orbital wall defects from trauma confirmed by computer tomographic (ct) scans, after osteotomies * excludes patients with diabetes mellitus, known allergies to polycaprolactone \& its analogues, know allergies to tricalcium phosphate \& its analogues, infections generalised \& around the orbital region trial duration : april 2010 - march 2015 follow up: * postoperative 1 week, 1 month, 3 months, 6 months, and 12 months * computer tomographic (ct) scan of orbits immediate postoperative and at 12 months appointment * all patients will be seen \& assessed in the plastic \& ophthalmology outpatient clinics by principal investigator (pi) and collaborators end point : * endpoint for follow-up is 12 months * all patients are assessed for assessed for diplopia, enophthalmos, exophthalmos, visual acuity, mobility of the globe, contour symmetry * all patients will have a computer tomographic (ct) scan of the orbits at 12 months to assess the bony orbit \& orbital volume * patients will be discharged from follow up at 12 months if asymptomatic * patients with complications will exit the protocol \& will be treated on their merits eg. infection - removal of implant, etc data management : * maintained by the principal investigator (pi) under repository of the research \& development office, national healthcare group (nhg) / national university health systems (nuhs), singapore * no data will be released without the permission of the principal investigator (pi) \& the research \& development office, national healthcare group (nhg) / national university health systems (nuhs), singapore

Eligibility criteria:
inclusion criteria: * age 21 y - 70 y * both males / females included * orbital fractures * defect after orbital osteotomies exclusion criteria: * patient refusal * infection around the orbit / generalised infection * diabetes mellitus * allergies to polycaprolactone \& its analogues * allergies to titanium

Keywords: orbital fractures enophthalmos diplopia eye