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

Area of Science:

• Biomaterials Science
• Craniofacial Surgery
• Medical Device Technology

Background:

• Personalized porous titanium implants (PTIs) are increasingly utilized for craniofacial reconstruction.
• Assessing the clinical performance and tolerance of PTIs is crucial for optimizing patient outcomes.

Purpose of the Study:

• To evaluate the clinical tolerance and performance of personalized porous titanium implants (PTIs) in craniofacial skeletal reconstruction.
• To identify risk factors associated with PTI failure in a diverse patient cohort.

Main Methods:

• A retrospective, international multicentric study involving adult patients who received PTIs over a 7-year period.
• Primary outcome: implant presence without revision. Secondary outcomes: infections, removal, fixation failure, exposure, re-intervention, and adverse events.
• Risk factor analysis for implant failure, including anatomical site and radiotherapy history.

Main Results:

• Ninety patients received 97 craniofacial PTIs, with a mean follow-up of 2.46 years. 81.1% of patients retained their implants.
• Overall success rates varied by site: 97.2% (skull), 78.8% (midface), and 57.1% (mandible).
• Complications were higher in the mandible group and irradiated patients, with radiotherapy increasing failure risk over 4-fold.

Conclusions:

• Personalized porous titanium implants (PTIs) demonstrate an acceptable overall benefit-risk profile for craniofacial applications.
• Patient selection is critical, necessitating consideration of the specific anatomical site and the patient's treatment history, particularly radiotherapy.
• Further research may refine patient selection criteria to enhance long-term success rates for PTIs.