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

Comparing the Reconstruction of the Orbit Fracture With a Poly Caprolactone / Tri-Calcium Phosphate ( PCL/TCP ) Implant vs. a Titanium Mesh Implant.

Sponsors

Lead Sponsor: National University Hospital, Singapore

Source 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

Overall Status Unknown status
Start Date April 2010
Completion Date March 2015
Primary Completion Date March 2015
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Enophthalmos 1 year
Secondary Outcome
Measure Time Frame
Diplopia 1 year
motility of the globe 1 year
Enrollment 80
Condition
Intervention

Intervention Type: Device

Intervention Name: Polycaprolactone / Tri-Calcium Phosphate

Description: Orbital implant for reconstruction of the orbital walls

Arm Group Label: Polycaprolactone / Tricalcium Phosphate

Other Name: Osteomesh Tri-Calcium Phosphate (TCP)

Intervention Type: Device

Intervention Name: Titanium Mesh

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

Arm Group Label: Control

Other Name: Titanium Orbital mesh

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

Gender: All

Minimum Age: 21 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Thiam Chye Lim, MD Principal Investigator Natioanl University Hospital, Singapore
Location
Facility: Status: Contact: Contact Backup: Investigator: National University Hospital Thiam Chye Lim [email protected] Thiam Chye Lim, FRCS Principal Investigator
Location Countries

Singapore

Verification Date

April 2014

Responsible Party

Name Title: LIM THIAM CHYE / Professor

Organization: National University Hospital / National Unviersity of Singapore

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Polycaprolactone / Tricalcium Phosphate

Type: Experimental

Description: Polycaprolactone / Tricalcium Phosphate group to assess efficacy of new implant

Label: Control

Type: Active Comparator

Description: Control group with titanium mesh

Acronym PCL/TCP
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov