Polycaprolactone / Tricalcium Phosphate (PCL/TCP) v Titanium Orbital Implant : Randomised Trial (PCL/TCP)

Comparing the Reconstruction of the Orbit Fracture With a Poly Caprolactone / Tri-Calcium Phosphate ( PCL/TCP ) Implant vs. a Titanium Mesh Implant.

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

Assess the presence of enophthalmos after reconstruction of the orbital walls at 1 week, 1 month, 3 months, 6 months and 12 months

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