Polycaprolactone / Tricalcium Phosphate (PCL/TCP) v Titanium Orbital Implant : Randomised Trial

Sponsor

National University Hospital, Singapore (Other)

Overall Status

Unknown status

CT.gov ID

NCT01119144

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Fractures Enophthalmos Diplopia	Device: Polycaprolactone / Tri-Calcium Phosphate Device: Titanium Mesh	Phase 2

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2010

Anticipated Primary Completion Date :

Mar 1, 2015

Anticipated Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Polycaprolactone / Tricalcium Phosphate Polycaprolactone / Tricalcium Phosphate group to assess efficacy of new implant	Device: Polycaprolactone / Tri-Calcium Phosphate Orbital implant for reconstruction of the orbital walls Other Names: Osteomesh Tri-Calcium Phosphate (TCP)
Active Comparator: Control Control group with titanium mesh	Device: Titanium Mesh Titanium mesh for comparison to Polycaprolactone / Tri-Calcium Phosphate (PCL / TCP) mesh Other Names: Titanium Orbital mesh

Arm

Intervention/Treatment

Experimental: Polycaprolactone / Tricalcium Phosphate

Polycaprolactone / Tricalcium Phosphate group to assess efficacy of new implant

Device: Polycaprolactone / Tri-Calcium Phosphate

Orbital implant for reconstruction of the orbital walls

Other Names:

Osteomesh Tri-Calcium Phosphate (TCP)

Active Comparator: Control

Control group with titanium mesh

Device: Titanium Mesh

Titanium mesh for comparison to Polycaprolactone / Tri-Calcium Phosphate (PCL / TCP) mesh

Other Names:

Titanium Orbital mesh

Outcome Measures

Primary Outcome Measures

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

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