Comparison of Cranioplasty With PEEK and Titanium

Brain Injuries Clinical Trial

Official title:

COMPREHENSIVE EVALUATION FOR CRANIOPLASTY WITH POLYETHERETHERKETONE AND TITANIUM IMPLANTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04707404
• Other study ID #: RJCP2020
• Status: Completed
• Start date: December 1, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Hematoma
• Hematoma of Head
• Skull Defect

Intervention

Procedure:
• Cranioplasty
The surgery implanted artificial material to repair the skull defect.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative improvement of GOSE score	The GOSE score in 6-month follow-up compared with the GOSE score in admission	December 2016 to Decemeber 2020
Other	Postoperative feelings	The subjective feelings for cranioplasty effect including 5 degrees of satisfaction and the Glasgow Benefit Inventory Score	May 2017 to Decemeber 2020
Primary	Complications	Postoperative complications including Incision infection, Subcutaneous infection, Postoperative hematoma, Subcutaneous effusion, New seizure, Implants exposure and Implants removal.	December 2016 to December 2020
Secondary	Postoperative cranial symmetry	The postoperative cranial symmetry derived from the reconstruction of postoperative CT image.	December 2016 to July 2020