Status:

ACTIVE_NOT_RECRUITING

3D Printed PEEK Implants for Cranioplasty

Lead Sponsor:

Skane University Hospital

Collaborating Sponsors:

Region Skane

Lund University

Conditions:

Skull Defect

Eligibility:

All Genders

18+ years

Phase:

NA

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 (...

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...

Eligibility Criteria

Inclusion

  • Scheduled for cranioplasty
  • Informed consent

Exclusion

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

Key Trial Info

Start Date :

November 26 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 26 2025

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT05291754

Start Date

November 26 2021

End Date

November 26 2025

Last Update

February 5 2024

Active Locations (1)

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1

Department of Neurosurgery

Lund, Sweden, 22185