Evaluation of implant properties, safety profile and clinical efficacy of patient-specific acrylic prosthesis in cranioplasty using 3D binderjet printed cranium model: A pilot study

There exists a significant demand to develop patient-specific prosthesis in reconstruction of cranial vaults after decompressive craniectomy. we report here, the outcomes of an unicentric pilot study on acrylic cranial prosthesis fabricated using a 3D printed cranium model with its clinically relevant mechanical properties. Methods The semi-crystalline polymethyl methacrylate (PMMA) implants, shaped to the cranial defects of 3D printed cranium model, were implanted in 10 patients (mean age, 40.8 ± 14.8 years). A binderjet 3D printer was used to create patient-specific mould and PMMA was casted to fabricate prosthesis which was analyzed for microstructure and properties. Patients were followed up for allergy, infection and cosmesis for a period of 6 months. Results As-cast PMMA flap exhibited hardness of 15.8 ± 0.24Hv, tensile strength of 30.7 ± 3.9 MPa and elastic modulus of 1.5 ± 0.1 GPa. 3D microstructure of the semi-crystalline acrylic implant revealed 2.5–15 µm spherical isolated pores. The mean area of the calvarial defect in craniectomy patients was 94.7 ± 17.4 cm2. We achieved a cranial index of symmetry (CIS -%) of 94.5 ± 3.9, while the average post-operative Glasgow outcome scale (GOS) score recorded was 4.2 ± 0.9. Conclusions 3D printing based patient-specific design and fabrication of acrylic cranioplasty implant is safe and achieves acceptable cosmetic and clinical outcomes in patients with decompressive craniectomy. Our study ensured clinically acceptable structural and mechanical properties of implanted PMMA, suggesting that a low cost 3D printer based PMMA flap is an affordable option for cranioplasty in resource constrained settings.