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

April 24, 2014 updated by: National University Hospital, Singapore

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Polycaprolactone / Tricalcium Phosphate
Polycaprolactone / Tricalcium Phosphate group to assess efficacy of new implant
Device: Polycaprolactone / Tri-Calcium Phosphate
Orbital implant for reconstruction of the orbital walls
Other Names:
  • Osteomesh Tri-Calcium Phosphate (TCP)
Active Comparator: Control
Control group with titanium mesh
Device: Titanium Mesh
Titanium mesh for comparison to Polycaprolactone / Tri-Calcium Phosphate (PCL / TCP) mesh
Other Names:
  • Titanium Orbital mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enophthalmos
Time Frame: 1 year
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diplopia
Time Frame: 1 year
Assess the evidence of diplopia on follow up at 1 week, 1 month, 3 months, 6 months and 12 months
1 year
motility of the globe
Time Frame: 1 year
assess globe motility on follow up at 1 week, 1 month, 3 months, 6 months, and 12 months
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Investigators

  • Principal Investigator: Thiam Chye Lim, MD, Natioanl University Hospital, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

May 5, 2010

First Submitted That Met QC Criteria

May 6, 2010

First Posted (Estimate)

May 7, 2010

Study Record Updates

Last Update Posted (Estimate)

April 28, 2014

Last Update Submitted That Met QC Criteria

April 24, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUHS/SUR/2010/1
  • D / 08 / 465 (Registry Identifier: D / 08 / 465)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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