Skull Defect Clinical Trial
Official title:
3D Printed PEEK Implants for Cranioplasty
This study is a non-randomised and single center study with patients needing an artificial skull bone eg cranioplasty. 40 patients will be implanted with in house manufactured polyether ether ketone (PEEK) implants using a fused filament fabrication 3D printer. The primary aim is to ascertain safety and feasibility of the procedure. The secondary aim is to compare complication rates with conventional methods such as autologous bone and polymethylmetacrylate (PMMA).
Cranioplasty is the surgical repair of a congenital or cranial defects after head trauma, infection or decompressive craniectomy. Although some patients can tolerate cranial defects for varied periods of time, cranioplasty is mostly indicated due to the increased risk of additional brain trauma, local pain or impaired CSF circulation but also aesthetic and psychological issues. The gold standard for repair since many years is cranioplasty with autologous bones . However, sometimes it not feasible to use the patient's autologous bone due to infections, trauma, bone graft resorption and donor-site morbidity. To replace the autologous bone grafts several different materials have been used, or are in use, as titanium meshes, hydroxyapatite cement and plastic resins as polymethyl methacrylate (PMMA) and porous polyethylene. Some of these have gathered increased interest due to advancements in technology for manufacture of these materials, and also the possibility to create custom made implants or moulds. The present study aims to assay safety and feasibility of in house 3D printed medical grade PEEK implants in research persons with acquired skull defects. The implants will be manufactured after 3D rendering from CT images of the skull defects, sterilised and aseptically inserted in the defects by means of a surgical intervention. A safety interim analysis will be performed after inclusion of 10 patients. ;
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