Clinical trial NCT01119144: Polycaprolactone / Tricalcium Phosphate (PCL/TCP) v Titanium Orbital Implant : Randomised 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Fractures
Enophthalmos
Diplopia
Keywords: Orbital
fractures
enophthalmos
diplopia
eye
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2010-05-07
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Enophthalmos
timeFrame: 1 year
Secondary outcomes:
measure: Diplopia
timeFrame: 1 year
measure: motility of the globe
timeFrame: 1 year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: Natioanl University Hospital, Singapore
name: Thiam Chye Lim, MD
role: PRINCIPAL_INVESTIGATOR
References: