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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Fractures, Enophthalmos, Diplopia

Intervention / Treatment
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* Device: Polycaprolactone / Tri-Calcium Phosphate
* Device: Titanium Mesh


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polycaprolactone / Tricalcium Phosphate<br>Polycaprolactone / Tricalcium Phosphate group to assess efficacy of new implant | Device: Polycaprolactone / Tri-Calcium Phosphate<br>* Orbital implant for reconstruction of the orbital walls<br>* Other names: Osteomesh Tri-Calcium Phosphate (TCP);|
| Active Comparator: Control<br>Control group with titanium mesh | Device: Titanium Mesh<br>* Titanium mesh for comparison to Polycaprolactone / Tri-Calcium Phosphate (PCL / TCP) mesh<br>* Other names: Titanium Orbital mesh;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enophthalmos | Assess the presence of enophthalmos after reconstruction of the orbital walls at 1 week, 1 month, 3 months, 6 months and 12 months | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diplopia | Assess the evidence of diplopia on follow up at 1 week, 1 month, 3 months, 6 months and 12 months | 1 year | 
| motility of the globe | assess globe motility on follow up at 1 week, 1 month, 3 months, 6 months, and 12 months | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orbital, fractures, enophthalmos, diplopia, eye