Presentation and short-term evaluation of an all-in-one patient-specific implant for cranial reconstruction: A randomized controlled trial

Abstract

Cranial reconstruction after bone graft harvesting remains a challenge. A patient-specific implant (PSI) to guide harvesting and reconstruction was evaluated and compared with the use of a free-hand procedure with calcium phosphate cement (C). Patients were randomized to either the PSI or C group. The outcome was measured clinically and radiographically as the primary endpoint. Secondary endpoints were ease of application, patient and surgeon satisfaction, and the complication rate. Twenty patients were randomized to the PSI (n=10) and C (n=10) groups. Two PSI patients were switched to the cement group due to a poor fit of the PSI. There was a non-significant trend towards more successful outcomes in the PSI group. Two PSI patients presented palpable screws, and one cement patient had a palpable dimple. Cone beam computed tomography showed a significantly lower median volume discrepancy in the PSI group (P<0.0001). The total surgical manipulation time was significantly higher in the PSI group. At 10 days postoperative, three PSI and two C patients presented with minor postoperative complications. There was no significant difference in patient or surgeon satisfaction. PSIs are a reliable alternative to cement. This PSI is novel as it also serves as a guide for harvesting the bone blocks required for reconstructive purposes.