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

NCT01119144 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-04-28

No results posted yet for this study

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

Conditions

  • Fractures
  • Enophthalmos
  • Diplopia

Interventions

DEVICE

Polycaprolactone / Tri-Calcium Phosphate

Orbital implant for reconstruction of the orbital walls

DEVICE

Titanium Mesh

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

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Thiam Chye Lim, MD · Natioanl University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01119144 on ClinicalTrials.gov