Fractures Clinical Trial
Official title:
Comparing the Reconstruction of the Orbit Fracture With a Poly Caprolactone / Tri-Calcium Phosphate ( PCL/TCP ) Implant vs. a Titanium Mesh Implant.
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
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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