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3D Printed PEEK Implants for Cranioplasty

Study acronym: PEEKCP
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date changed from estimate of Oct 26, 2025 to Dec 26, 2025
    • Study completion date: Nov 26, 2025 to Mar 26, 2026
    v5
  2. Primary completion date: Oct 26, 2023 to Oct 26, 2025
    • Study completion date: Nov 26, 2023 to Nov 26, 2025
    v4
  3. Primary completion date: Oct 26, 2022 to Oct 26, 2023
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v3
  4. Phase: Phase 1 to Not applicable
    • Primary endpoints revised (2)
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05291754
Lead Sponsor Skane University Hospital
Collaborators: Region Skane, Lund University
Conditions
(from sponsor)		 Skull Defect
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov