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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


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
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