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

2014-08-27 03:13:53 | BioPortfolio

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 2013

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

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 2013

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

Conditions

Fractures

Intervention

Polycaprolactone / Tri-Calcium Phosphate, Titanium Mesh

Location

National University Hospital
Singapore
Singapore
119074

Status

Recruiting

Source

National University Hospital, Singapore

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:53-0400

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Medical and Biotech [MESH] Definitions

Adhesives used to fix prosthetic devices to bones and to cement bone to bone in difficult fractures. Synthetic resins are commonly used as cements. A mixture of monocalcium phosphate, monohydrate, alpha-tricalcium phosphate, and calcium carbonate with a sodium phosphate solution is also a useful bone paste.

A dark-gray, metallic element of widespread distribution but occurring in small amounts; atomic number, 22; atomic weight, 47.90; symbol, Ti; specific gravity, 4.5; used for fixation of fractures. (Dorland, 28th ed)

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Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.

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