An interventional study of PEEK Cranioplasty in Skull Defect, sponsored by Skane University Hospital. Active, not recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Skane University Hospital · Not applicable, Interventional, and Treatment
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.
Skane University Hospital is the lead sponsor of 71 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: PEEK Cranioplasty
3D printed PEEK skull implant
Performed PEEK implants
Percentage of performed PEEK implants out of included patients.
Time frame: At end of surgical procedure, up to 2 months after inclusion
Safety of PEEK implants
Survival percentage of PEEK implants. Will be compared to historical PMMA and autologous bone implants.
Time frame: 1 year
Exposure time of PEEK implants compared to PMMA implants.
Compare exposure time for PEEK implant during surgery with historical PMMA implants made in 3D printed mold.
Time frame: During surgical procedure, up to 2 months after inclusion.
Complications of PEEK implants
Complications after PEEK implants other than those leading to extraction of implant will be compared to historical PMMA and autologous bone implants.
Time frame: 12 months
This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Skane University Hospital