ClinicalTrials.Veeva

Menu

Comparison of Cranioplasty With PEEK and Titanium

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Completed

Conditions

Brain Injuries
Skull Defect
Hematoma of Head

Treatments

Procedure: Cranioplasty

Study type

Observational

Funder types

Other

Identifiers

NCT04707404
RJCP2020

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

PEEK
Description:
Cranioplasty patients with PEEK.
Treatment:
Procedure: Cranioplasty
Titanium
Description:
Cranioplasty patients with titanium mesh.
Treatment:
Procedure: Cranioplasty

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems