3D Printed PEEK Implants for Cranioplasty (PEEKCP)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Skull Defect
• Intervention / Treatment: Device: PEEK Cranioplasty

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 22185
    • Department of Neurosurgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Scheduled for cranioplasty
• Informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cranioplasty PEEK	Device: PEEK Cranioplasty; 3D printed PEEK skull implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performed PEEK implants	Percentage of performed PEEK implants out of included patients.	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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

Collaborators and Investigators

• Sponsor: Skane University Hospital
• Collaborators: Lund University; Region Skane
• Investigators: Study Director: Einar Heiberg, MD, PhD, Skåne University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2021
• Primary Completion (Estimated): October 26, 2025
• Study Completion (Estimated): November 26, 2025

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 23, 2022

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: PEEK; Cranioplasty; 3D printer
• Other Study ID Numbers: Ver1.2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No