UnknownPhase 2

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

Singapore80 participantsStarted 2010-04

Plain-language 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

Who can participate

Age range21 Years – 70 Years

SexALL

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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

What they're measuring

Enophthalmos

Timeframe: 1 year

Trial details

NCT IDNCT01119144

SponsorNational University Hospital, Singapore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-03

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