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

Phase 2

• Conditions: Fractures; Enophthalmos; Diplopia

• 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

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-05-06
• Study First Posted: 2010-05-07
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-24
• Last Update Posted: 2014-04-28
• Primary Completion: 2015-03
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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