Clinical Trial: Polycaprolactone / Tricalcium Phosphate (PCL/TCP) v Titanium Orbital Implant : Randomised Trial
Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Comparing the Reconstruction of the Orbit Fracture With a Poly Caprolactone / Tri-Calcium Phosphate ( PCL/TCP ) Implant vs. a Titanium Mesh Implant.
Brief 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 Summary:
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 month
Sponsor: National University Hospital, Singapore
Current Primary Outcome: Enophthalmos [ Time Frame: 1 year ]
Assess the presence of enophthalmos after reconstruction of the orbital walls at 1 week, 1 month, 3 months, 6 months and 12 months
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Diplopia [ Time Frame: 1 year ]Assess the evidence of diplopia on follow up at 1 week, 1 month, 3 months, 6 months and 12 months
- motility of the globe [ Time Frame: 1 year ]assess globe motility on follow up at 1 week, 1 month, 3 months, 6 months, and 12 months
Original Secondary Outcome: Same as current
Information By: National University Hospital, Singapore
Dates:
Date Received: May 5, 2010
Date Started: April 2010
Date Completion: March 2015
Last Updated: April 24, 2014
Last Verified: April 2014
- Diplopia [ Time Frame: 1 year ]