Safe and easy application of BioComp implants for episthetic reconstruction of craniofacial defects - A pilot study

At the department Cranio-Maxillofacial Surgery of Maastricht University Medical
Center (MUMC) the routine procedure after ablation of the nose, ear or eye is
reconstruction with an episthesis. Retention can be achieved using adhesives,
undercuts or bone implants. Implant based epithesis are now commonly used
because of the good retention and epithesis stability. This results in a better
patient quality of life.
Today we use 4mm machined surface implants (Cochlear Vistafix system) for the
region of the orbit and the ear and 8 mm implants (Nobel Replace system) for
the nose region. Each system has its own instruments and application method. To
enhance the clinical usability, we are searching for one system for all
extra-oral implant regions.
Implant patients may be compromised by aging, diseases, smoking, medication and
radiation therapy, which can affect the bone healing process. In these cases,
implants are known to have higher failure rates compared to the application in
healthy cases. Therefore implants with biomechanical surface modifications may
have a positive effect on osseointegration, resulting in higher success rates.
Hypothesis: 4mm surface treated implants (HAVD, BioComp) in the orbit and ear
region and 8mm surface treated implants (HAVD, BioComp) in the nose region are
the ideal system for later episthetic reconstruction.

In this study we want to investigate the efficacy and safety of an implant
system with a surface coating (Biocomp) for episthetic reconstruction after
ablative surgery in the nasal, orbital and auricular region

this is a pilot prospective clinical trial

Depending on the craniofacial region, 2-4 implants will be placed directly
after ablation surgery of the ear, nose or eye/orbital cavity. The exact
location of the implants will be planned pre-operatively (CAD) using the
information of a CT-scan.

The patient must visit the clinic as often as in the known standard treatment .
No extra visits are needed. No invasive interventions are needed for endpoint
measurements.
Based on literature findings, we expect that the benefit of participating in
this study may be a better implant integration with a long lasting success for
the patient. Second benefit could be a reduced procedure time due to the
improved and simplified handling properties of the new implant system. The
risks associated with participation are not different from the risks known
today. A mild skin reaction or implant failure can occur. In the latter
scenario a second intervention may be needed to remove and replace the implant.