Comparison of Cranioplasty With PEEK and Titanium

Completed

• Conditions: Brain Injuries; Hematoma of Head; Skull Defect
• Interventions: Procedure: Cranioplasty

• Registration Number: NCT04707404
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-12-01
• Primary Completion: 2020-07-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Last Update Submitted: 2021-01-12
• Study First Posted: 2021-01-13
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Titanium	Cranioplasty	Cranioplasty patients with titanium mesh.
PEEK	Cranioplasty	Cranioplasty patients with PEEK.

Primary Outcome Measures

Name	Time	Method
Complications	December 2016 to December 2020	Postoperative complications including Incision infection, Subcutaneous infection, Postoperative hematoma, Subcutaneous effusion, New seizure, Implants exposure and Implants removal.

Secondary Outcome Measures

Name	Time	Method
Postoperative cranial symmetry	December 2016 to July 2020	The postoperative cranial symmetry derived from the reconstruction of postoperative CT image.