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Use of a Low Profile Titanium Mesh in Orbital Reconstruction

NCT01432964 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 27

Last updated 2011-09-13

No results posted yet for this study

Summary

In craniofacial trauma, the involvement of orbital structures is noted in up to 40% of cases (Ellis 1985). Post-traumatic orbital deformities caused by incorrect reconstruction of orbital dimensions are severe complications causing enophthalmos, diplopia and visual acuity disturbance. To prevent such complications, immediate repair of orbital injuries with the restoration of normal anatomy is indicated in orbital floor fractures. With the help of biodegradable implants small and medium-sized defects are easily managed (Büchel 2005, Lieger 2010). In extensive fractures however, only calvarian bone and titanium mesh considered to provide a sufficient support of the orbital content.

Calvarial bone can be difficult to mould and to adapt to the form and size of the orbital lesion. In addition, donor site morbidity cannot be disregarded. Orbital reconstruction mesh on the other hand is always available and easier to apply. There are however important requirements for these meshes, such as biocompatibility, excellent stability, optimal adaptability and patient comfort. Recently, the company Medartis developed a titanium mesh featuring a low profile. In order to regain normal function, normal anatomy has to be re-established. It therefore seemed reasonable to assess an implant, which would facilitate orbital reconstruction without disturbing normal anatomy by its size, profile height or properties.

The purpose of this study was to assess the use and accuracy of the low profile titanium mesh for primary internal orbital reconstruction.

Conditions

  • Orbital Fractures

Interventions

PROCEDURE

Orbital revision surgery

Surgical revisions were performed under general anaesthesia. The orbital floor was routinely exposed via a transconjunctival incision. In patients with involvement of the medial wall, a combined transconjunctival-transcaruncular approach was used. Herniated or incarcerated tissue was then complete repositioned. Stable borders around the bony defect in the orbital floor were exposed. The aluminium template was pre-bend and controlled in situ. Type and size of mesh were chosen and adjustments performed, as needed. Following the bending of the titanium mesh according to the template, it was inserted and fixed with 1.5mm screws. Alternatively the mesh could be preformed, using a sterilized skull model to shape and contour it to a normal orbit. Finally the eye bulb mobility was controlled using fine forceps (forced duction test) and the wound closed (Vicryl 5/0 rapid; optional).

Sponsors & Collaborators

  • International Bone Research Association

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Olivier Lieger, MD, DMD · Department of Oral and Maxillofacial Surgery, University Hospital Bern, Switzerland

  • Tateyuki Iizuka, MD, DDS, PhD · Department of Oral and Maxillofacial Surgery, University Hospital Bern, Switzerland

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Completion
2010-10-31

Countries

  • Switzerland

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 NCT01432964 on ClinicalTrials.gov