Fractures Clinical Trial
— PCL/TCPOfficial 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
Status | Recruiting |
Enrollment | 80 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Singapore | National University Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University Hospital, Singapore |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Enophthalmos | Assess the presence of enophthalmos after reconstruction of the orbital walls at 1 week, 1 month, 3 months, 6 months and 12 months | 1 year | No |
Secondary | Diplopia | Assess the evidence of diplopia on follow up at 1 week, 1 month, 3 months, 6 months and 12 months | 1 year | No |
Secondary | motility of the globe | assess globe motility on follow up at 1 week, 1 month, 3 months, 6 months, and 12 months | 1 year | No |
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