3D Printed PEEK Implants for Cranioplasty

Skull Defect Clinical Trial

— PEEKCP  

Official title:

3D Printed PEEK Implants for Cranioplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05291754
• Other study ID #: Ver1.2
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 26, 2021
• Est. completion date: November 26, 2025

Study information

• Verified date: February 2024
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: November 26, 2025
• Est. primary completion date: October 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled for cranioplasty
• Informed consent

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Skull Defect

Intervention

Device:
• PEEK Cranioplasty
3D printed PEEK skull implant

Locations

Country	Name	City	State
Sweden	Department of Neurosurgery	Lund

Sponsors (3)

Lead Sponsor	Collaborator
Skane University Hospital	Lund University, Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performed PEEK implants	Percentage of performed PEEK implants out of included patients.	At end of surgical procedure, up to 2 months after inclusion
Primary	Safety of PEEK implants	Survival percentage of PEEK implants. Will be compared to historical PMMA and autologous bone implants.	1 year
Secondary	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.	During surgical procedure, up to 2 months after inclusion.
Secondary	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.	12 months