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Clinical Trial 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


Clinical Trial 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 ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01119144
Study type Interventional
Source National University Hospital, Singapore
Contact
Status Recruiting
Phase Phase 2
Start date April 2010
Completion date March 2015

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