Patient-Specific Cranio-Facial Porous Titanium Implants: A Multicentric Cohort Study.

OBJECTIVE

To investigate the clinical tolerance and performance of personalized porous titanium implants (PTIs) used on the craniofacial skeleton.

STUDY

DESIGN

Retrospective study.

SETTING

International multicentric study.

METHODS

Adult patients who received PTIs during a 7-year period were included. The primary outcome was the presence of the PTI at the last visit without surgical revision. Local and systemic infections, implant removal, fixation device failure, exposure, re-intervention, and adverse events were assessed at the last visit. We also analyzed risk factors for implant failure.

RESULTS

Ninety patients (36, 33, and 21 in the skull, midface, and mandible groups, respectively) with 97 craniofacial PTIs were followed up for a mean of 2.46 years after surgery. At the last visit, 73 patients (81.1%) still had their implant. Overall success rates were 97.2%, 78.8%, and 57.1% for the skull, midface, and mandible groups, respectively. Most complications and implant removals occurred in the mandible group and irradiated patients. On the whole cohort, radiotherapy was associated with a > 4-time higher risk of failure.

CONCLUSION

This study demonstrated an acceptable PTIs overall benefit-risk profile. However, we recommend a careful selection of patients, taking into account anatomical site and treatment history.