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

Fractures Clinical Trial

— PCL/TCP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01119144
• Other study ID #: NUHS/SUR/2010/1
• Secondary ID: D / 08 / 465
• Status: Recruiting
• Phase: Phase 2
• First received: May 5, 2010
• Last updated: April 24, 2014
• Start date: April 2010
• Est. completion date: March 2015

Study information

• Verified date: April 2014
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diplopia
• Enophthalmos
• Fractures

Intervention

Device:
• Polycaprolactone / Tri-Calcium Phosphate
Orbital implant for reconstruction of the orbital walls
• Titanium Mesh
Titanium mesh for comparison to Polycaprolactone / Tri-Calcium Phosphate (PCL / TCP) mesh

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enophthalmos	Assess the presence of enophthalmos after reconstruction of the orbital walls at 1 week, 1 month, 3 months, 6 months and 12 months	1 year	No
Secondary	Diplopia	Assess the evidence of diplopia on follow up at 1 week, 1 month, 3 months, 6 months and 12 months	1 year	No
Secondary	motility of the globe	assess globe motility on follow up at 1 week, 1 month, 3 months, 6 months, and 12 months	1 year	No