Objective and importance: We have developed novel biodegradable polymer implants by using the rapid prototyping technology fused deposition modeling. Early results of a clinical pilot study for cranioplasty are presented.
Clinical presentation: Five patients with the diagnosis of chronic subdural hematoma were included in the study. After trephination and evacuation of the subdural hematoma, burr holes (diameter, 14 mm) were closed using a biodegradable implant made of polycaprolactone. Implants were computer designed with an upper rim diameter of 16 mm and a 14 mm body diameter with a fully interconnected, honeycomb-like architecture of 400 to 600 microm in pore size.
Intervention: Postoperative computed tomographic scans indicated that the plugs were stably anchored in the osseous host environment with no fluid collection detectable. The postoperative course was uneventful, and patients were discharged after 5 days. Follow-up scans after 3, 6, and 12 months showed that the implants were well integrated in the surrounding calvarial bone with new bone filling the porous space.
Conclusion: These novel polymer scaffolds made of the slow-degrading material polycaprolactone represent a suitable implant for closure of post-trephination defects.