Comparison of Cranioplasty With PEEK and Titanium

COMPREHENSIVE EVALUATION FOR CRANIOPLASTY WITH POLYETHERETHERKETONE AND TITANIUM IMPLANTS

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.

Study Overview

• Status: Completed
• Conditions: Brain Injuries; Hematoma of Head; Skull Defect
• Intervention / Treatment: Procedure: Cranioplasty

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 Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients received cranioplasty with PEEK and titanium from December 2016 to July 2020 in Renji hospital.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PEEK; Cranioplasty patients with PEEK.	Procedure: Cranioplasty; The surgery implanted artificial material to repair the skull defect.
Titanium; Cranioplasty patients with titanium mesh.	Procedure: Cranioplasty; The surgery implanted artificial material to repair the skull defect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative cranial symmetry	The postoperative cranial symmetry derived from the reconstruction of postoperative CT image.	December 2016 to July 2020

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Postoperative feelings	The subjective feelings for cranioplasty effect including 5 degrees of satisfaction and the Glasgow Benefit Inventory Score	May 2017 to Decemeber 2020

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Outcomes; Complications; PEEK; Titanium; Cranioplasty; Subcutaneous effusion
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Hematoma
• Other Study ID Numbers: RJCP2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No