Use of PEEK Devices to Fix Custom-Made Porous Hydroxyapatite Prostheses: Reliability and Efficacy of Cranioplasty Fixation Method with a Long-Term Follow-Up

Cranioplasty with porous hydroxyapatite (PHA) implants is a well-established technique for cranial reconstruction. However, literature data indicate a higher incidence of implant displacement compared to other bone substitutes. This may be attributed to the intrinsic fragility of PHA in its early phase, which limits the use of conventional fixation systems such as plates and screws. Currently, only non-absorbable silk sutures are validated by the manufacturer for fixation, raising concerns about the long-term stability of the implant. In this context, the use of clamp-like PEEK fixators, such as the Cranial LOOP®, may represent a more secure and reliable alternative. This case series describes seven patients who underwent cranioplasty using customized PHA implants fixed with Cranial LOOP® devices. Clinical, aesthetic, and radiological outcomes were assessed over a mean fol-low-up period of 42 months. All patients showed excellent integration of the prosthesis and sustained long-term stability. No cases of implant displacement, infection, or hard-ware-related complications were recorded. The results suggest that the Cranial LOOP® system provides a safe and effective fixation method for PHA implants, with excellent patient satisfaction and no observed adverse events over extended follow-up. This ap-proach may be considered a valuable alternative in cases where the mechanical limitations of PHA require a fixation strategy that minimizes stress on the implant while ensuring stability over time.