Comparison of Cranioplasty With PEEK and Titanium

Study Overview
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Brief Summary
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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
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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.

Official Title
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COMPREHENSIVE EVALUATION FOR CRANIOPLASTY WITH POLYETHERETHERKETONE AND TITANIUM IMPLANTS

Conditions
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Brain Injuries, Hematoma of Head, Skull Defect

Intervention / Treatment
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* Procedure: Cranioplasty


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PEEK<br>Cranioplasty patients with PEEK. | Procedure: Cranioplasty<br>* The surgery implanted artificial material to repair the skull defect.<br>|
| Titanium<br>Cranioplasty patients with titanium mesh. | Procedure: Cranioplasty<br>* The surgery implanted artificial material to repair the skull defect.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cranioplasty, PEEK, Titanium, Outcomes, Complications, Subcutaneous effusion