NCT05291754

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 (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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 26, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2026

Completed
Last Updated

January 21, 2026

Status Verified

October 1, 2025

Enrollment Period

4.1 years

First QC Date

November 26, 2021

Last Update Submit

January 16, 2026

Conditions

Skull Defect

Keywords

PEEKCranioplasty3D printer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Exposure time of PEEK implants compared to PMMA implants.

    During surgical procedure, up to 2 months after inclusion.

  • Complications of PEEK implants

    12 months

Study Arms (1)

Cranioplasty PEEK

OTHER
Device: PEEK Cranioplasty

Interventions

PEEK CranioplastyDEVICE

3D printed PEEK skull implant

Cranioplasty PEEK

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for cranioplasty
  • Informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery

Lund, 22185, Sweden

Location

Study Officials

  • Einar Heiberg, MD, PhD

    Skane University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, non randomised and single arm
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 26, 2021

First Posted

March 23, 2022

Study Start

November 26, 2021

Primary Completion

December 26, 2025

Study Completion

March 26, 2026

Last Updated

January 21, 2026

Record last verified: 2025-10

Locations

SE(1)