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

Fractures Clinical 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.

Status Recruiting

Clinical Trial 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

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diplopia
• Enophthalmos
• Fractures

• NCT number: NCT01119144
• Study type: Interventional
• Source: National University Hospital, Singapore
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2010
• Completion date: March 2015