NCT01119144

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

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

Conditions

• Fractures
• Enophthalmos
• Diplopia

Interventions

Type	Name	Description
DEVICE	Polycaprolactone / Tri-Calcium Phosphate	Orbital implant for reconstruction of the orbital walls
DEVICE	Titanium Mesh	Titanium mesh for comparison to Polycaprolactone / Tri-Calcium Phosphate (PCL / TCP) mesh

Timeline

• Start date: 2010-04-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2010-05-07
• Last updated: 2014-04-28

Locations

1 site across 1 country: Singapore