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Clinical Trials in Sweden / NCT05291754
Active, not recruiting Not applicable

3D Printed PEEK Implants for Cranioplasty

NCT05291754 · tracked via the Priya Life Science Sweden tracker
Sponsor
Skane University Hospital
Phase
Not applicable
Started
2021-11-26
Last updated
2026-01-21

Condition(s) studied

Skull Defect

Investigational drug(s) / intervention(s)

PEEK Cranioplasty

PEEK Cranioplasty: 3D printed PEEK skull implant

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Scheduled for cranioplasty * Informed consent Exclusion Criteria: * No informed consent * Implant size greater than 12x12 cm

Primary outcome measure(s)

  • Performed PEEK implants — At end of surgical procedure, up to 2 months after inclusion
    Percentage of performed PEEK implants out of included patients.
  • Safety of PEEK implants — 1 year
    Survival percentage of PEEK implants. Will be compared to historical PMMA and autologous bone implants.

Trial sites (1)

FacilityCityRegionStatus
Department of Neurosurgery Lund Sweden

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05291754 on ClinicalTrials.gov ↗ ← All trials in Sweden