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3D Printed PEEK Implants for Cranioplasty

NCT05291754 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-21

No results posted yet for this 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).

Conditions

  • Skull Defect

Interventions

DEVICE

PEEK Cranioplasty

3D printed PEEK skull implant

Sponsors & Collaborators

  • Region Skane

    collaborator OTHER

  • Lund University

    collaborator OTHER

  • Skane University Hospital

    lead OTHER

Principal Investigators

  • Einar Heiberg, MD, PhD · Skane University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-26
Primary Completion
2025-12-26
Completion
2026-03-26

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05291754 on ClinicalTrials.gov