Skip to main content
OpenTrials
Completed

NCT Number: NCT04707404

Comparison of Cranioplasty With PEEK and Titanium

Decompressive craniectomy is suggested as an effective surgical intervention for patients with high intracranial pressure. Recently, various customized artificial materials are increasingly employed, e.g., titanium and polyetheretherketone (PEEK). The application of PEEK in cranioplasty is increasing, while its comprehensive evaluation in clinical practice is still insufficient, especially when comparing with the effects of titanium implant. We thus designed the study to evaluate the comprehensive effects of the cranioplasty with PEEK vs titanium.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brain Injuries Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Hematoma of Head Nervous System Diseases Skull Defect Trauma, Nervous System Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

About this study

Decompressive craniectomy (DC) is suggested as an effective surgical intervention for patients with high intracranial pressure. For the skull defect after DC, cranioplasty could pro-vide protection, aesthetic and even functional improvements. The autologous bone flap (ABF) was once thought to be an optimal autograft for repairing [8]. While accumulated studies reported ABF related disadvantages. Recently, various customized artificial materials are increasingly employed, e.g., titanium and polyetheretherketone (PEEK).

Titanium is a widely applied metal material for cranioplasty, attribute to its high strength, bio-compatibility and comparatively low material cost. Currently, pre-operative three dimensional (3D) reconstruction of titanium brings a customized implant for optimal shaping effect. However, titanium implant is still confronted with complications of infection, implant exposure, etc.

PEEK is a novel polymer used to rebuild the personalized construction. Through the precise computational reconstruction of high-resolution computed tomography (CT) scanning, the customized PEEK could more accurately rebuild the complex cranial and maxillofacial structure. The application of this material in cranioplasty is increasing, while its comprehensive evaluation in clinical practice is still insufficient, especially when comparing with the effects of titanium implant.

We thus designed the study to evaluate the comprehensive effects of the cranioplasty with PEEK vs titanium. The data of the patients implanted PEEK or titanium in four years in our institute were retrospectively collected and evaluated, in respects of the general information of patients, postoperative complications, shaping effects, and psychosocial improvements, to display a comprehensive evaluation for these two implants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients underwent cranioplasty with PEEK or Titanium.
  • Patients underwent cranioplasty and had complete data and 6-month follow-up records.

Exclusion criteria

  • Patients underwent cranioplasty with other material or ABF.
  • Patients had incomplete data or follow-up records.

Treatment and study plan

cranioplasty

Procedure

The surgery implanted artificial material to repair the skull defect.

Primary outcomes

  1. Complications

    Time frame: December 2016 to December 2020

    Postoperative complications including Incision infection, Subcutaneous infection, Postoperative hematoma, Subcutaneous effusion, New seizure, Implants exposure and Implants removal.

Secondary outcomes

  1. Postoperative cranial symmetry

    Time frame: December 2016 to July 2020

    The postoperative cranial symmetry derived from the reconstruction of postoperative CT image.

Other outcomes

  1. Postoperative improvement of GOSE score

    Time frame: December 2016 to Decemeber 2020

    The GOSE score in 6-month follow-up compared with the GOSE score in admission

  2. Postoperative feelings

    Time frame: May 2017 to Decemeber 2020

    The subjective feelings for cranioplasty effect including 5 degrees of satisfaction and the Glasgow Benefit Inventory Score

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

COMPREHENSIVE EVALUATION FOR CRANIOPLASTY WITH POLYETHERETHERKETONE AND TITANIUM IMPLANTS

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jan 13, 2021
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.