Clinical trial NCT05291754: 3D Printed PEEK Implants for Cranioplasty
Official title: 3D Printed PEEK Implants for Cranioplasty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Skull Defect
Keywords: PEEK
Cranioplasty
3D printer
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
Collaborators: name: Region Skane
name: Lund University
First posted: 2022-03-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non randomised and single arm
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Scheduled for cranioplasty
* Informed consent

Exclusion Criteria:

* No informed consent
* Implant size greater than 12x12 cm

Primary outcomes:
measure: Performed PEEK implants
timeFrame: At end of surgical procedure, up to 2 months after inclusion
measure: Safety of PEEK implants
timeFrame: 1 year
Secondary outcomes:
measure: Exposure time of PEEK implants compared to PMMA implants.
timeFrame: During surgical procedure, up to 2 months after inclusion.
measure: Complications of PEEK implants
timeFrame: 12 months
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Neurosurgery
Study officials:
affiliation: Skane University Hospital
name: Einar Heiberg, MD, PhD
role: STUDY_DIRECTOR
References: