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

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional



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

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