Polycaprolactone / Tricalcium Phosphate (PCL/TCP) v Titanium Orbital Implant : Randomised Trial
NCT ID: NCT01119144
Last Updated: 2014-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2010-04-30
2015-03-31
Brief Summary
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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
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Polycaprolactone / Tricalcium Phosphate
Polycaprolactone / Tricalcium Phosphate group to assess efficacy of new implant
Polycaprolactone / Tri-Calcium Phosphate
Orbital implant for reconstruction of the orbital walls
Control
Control group with titanium mesh
Titanium Mesh
Titanium mesh for comparison to Polycaprolactone / Tri-Calcium Phosphate (PCL / TCP) mesh
Interventions
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Polycaprolactone / Tri-Calcium Phosphate
Orbital implant for reconstruction of the orbital walls
Titanium Mesh
Titanium mesh for comparison to Polycaprolactone / Tri-Calcium Phosphate (PCL / TCP) mesh
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* both males / females included
* orbital fractures
* defect after orbital osteotomies
Exclusion Criteria
* infection around the orbit / generalised infection
* Diabetes mellitus
* allergies to polycaprolactone \& its analogues
* allergies to titanium
21 Years
70 Years
ALL
No
Sponsors
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National University Hospital, Singapore
OTHER
Responsible Party
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National University Hospital / National Unviersity of Singapore
Principal Investigators
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Thiam Chye Lim, MD
Role: PRINCIPAL_INVESTIGATOR
Natioanl University Hospital, Singapore
Locations
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National University Hospital
Singapore, Singapore, Singapore
Countries
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Facility Contacts
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Other Identifiers
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D / 08 / 465
Identifier Type: REGISTRY
Identifier Source: secondary_id
NUHS/SUR/2010/1
Identifier Type: -
Identifier Source: org_study_id
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