Polycaprolactone / Tricalcium Phosphate (PCL/TCP) v Titanium Orbital Implant : Randomised Trial
- Conditions
- FracturesEnophthalmosDiplopia
- Interventions
- Device: Polycaprolactone / Tri-Calcium PhosphateDevice: Titanium Mesh
- Registration Number
- NCT01119144
- Lead Sponsor
- National University Hospital, Singapore
- 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 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 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- age 21 y - 70 y
- both males / females included
- orbital fractures
- defect after orbital osteotomies
- patient refusal
- infection around the orbit / generalised infection
- Diabetes mellitus
- allergies to polycaprolactone & its analogues
- allergies to titanium
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Polycaprolactone / Tricalcium Phosphate Polycaprolactone / Tri-Calcium Phosphate Polycaprolactone / Tricalcium Phosphate group to assess efficacy of new implant Control Titanium Mesh Control group with titanium mesh
- Primary Outcome Measures
Name Time Method Enophthalmos 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
- Secondary Outcome Measures
Name Time Method Diplopia 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 1 year assess globe motility on follow up at 1 week, 1 month, 3 months, 6 months, and 12 months
Trial Locations
- Locations (1)
National University Hospital
🇸🇬Singapore, Singapore