3D Printed PEEK Implants for Cranioplasty

NCT ID: NCT05291754

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-26
• Study Completion Date: 2026-03-26

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.

Conditions

Skull Defect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cranioplasty PEEK

Group Type: OTHER

PEEK Cranioplasty

Intervention Type: DEVICE

3D printed PEEK skull implant

Interventions

PEEK Cranioplasty

3D printed PEEK skull implant

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Scheduled for cranioplasty
• Informed consent

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: collaborator

Skane University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peter Siesjö

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Einar Heiberg, MD, PhD

Role: STUDY_DIRECTOR

Skane University Hospital

Locations

Department of Neurosurgery

Lund, , Sweden

Countries

Sweden

Other Identifiers

Ver1.2

Identifier Type: -

Identifier Source: org_study_id