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

National University Health System (NUHS)

Status and phase: Unknown; Phase 2

Conditions: Diplopia; Fractures; Enophthalmos

Treatments: Device: Titanium Mesh; Device: Polycaprolactone / Tri-Calcium Phosphate

Study type: Interventional

Funder types: Other

Identifiers

NCT01119144

D / 08 / 465 (Registry Identifier)

NUHS/SUR/2010/1

Details and patient eligibility

About

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

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Polycaprolactone / Tricalcium Phosphate

Experimental group

Description:

Polycaprolactone / Tricalcium Phosphate group to assess efficacy of new implant

Treatment:

Device: Polycaprolactone / Tri-Calcium Phosphate

Control

Active Comparator group

Description:

Control group with titanium mesh

Treatment:

Device: Titanium Mesh