Controlled Study in Cranioplasty Reconstruction

Cranioplasty surgery is necessary everytime a craniolacuniae has to be reconstructed to ensure protection to the central nervous system. Cranioplasty surgery is classified into first line surgery, due to traumatic events or degenerative pathologies, and second line treatment, when due to first treatment failure, for example because of autologous bone reabsorption/infection or other material reject.

Clinical evaluation scores Specific and validated clinical scores will be employed for End-points evaluation.

CT scan will required in the pre-operation visit and in the post-operation time during the follow up visits to evaluate the bone-implant osteointegration process and osteointegration will be evaluated applying a specific score.

Data have been recorded in a e-CRF with limited access, protected by personal password.

Data will always be collected in an anonymous way, subjects identity will always be undisclosed.

Each patient will be asked to give informed consent to partecipate the study.

Inclusion criteria

• Patients which need cranial reconstruction,
• Cranioplasty reconstruction by autologous bone, hidroxyapatite or polymethylmethacrylate,
• Patients of both sex in age range between 14 and 75 years old,
• Craniolacuniae size > 25 cm2 ,
• Patients affected by complex pathologies or fracture or infection of a previous implant.
• Elegibility to CustomBone Service™ Cranial treatment will respect the product leaflet instructions.
• Each investigator will respect his own medical centre internal inclusion criteria to cranial reconstruction.

Exclusion criteria

• Patients affected by important emocoagulation pathologies,
• Patients affected by mellitus diabetes,
• Patients affected by autoimmune pathology,
• Patients unable to intend,
• Patients affected by immunodepression.