Safety of boneless reconstruction of the mandible with a CAD/CAM designed titanium device: The replica cohort study

Objective: We evaluated the safety of REPLICA, a CAD/CAM-designed patient-specific titanium mandible, in patients with mandibular defects not suitable for reconstruction with traditional techniques. Patients and methods: We performed a cohort study with a composite primary outcome assigned at the end of a 1- year follow-up. The outcome was assigned in the presence of all the following: 1) absence of intraoral or skin extrusion of REPLICA; 2) decrease or cessation of oral pain; 3) stability or increase in mouth opening; 4) resumption of oral feeding without the need of nasogastric tube; 5) absence of fracture at multidetector computer tomography (MDCT); 6) absence of displacement (MDCT); 7) absence of screw loosening (MDCT). The secondary outcome was the patient-reported QOL at 6 months of follow-up as detected by the EORTC QLQ-C30 and QLQ- H&N35 questionnaires. Results: Between March 2012 and June 2017, 18 consecutive patients, with a median (IQR) age of 67 (65;74) underwent reconstruction of mandibular defects with REPLICA at our Unit. The primary outcome was reached by 14 of the 18 patients. QOL data were available for 15 patients at the 6-month follow-up, showing a good profile of general and disease-specific QOL. Conclusion: REPLICA offered a safe solution at 1-year for the treatment of mandibular defects not suitable for reconstruction with traditional techniques, and was associated with subjective well-being and satisfaction. Further studies are needed to assess the full range of indications of REPLICA.