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Comparison of Cranioplasty With PEEK and Titanium

COMPREHENSIVE EVALUATION FOR CRANIOPLASTY WITH POLYETHERETHERKETONE AND TITANIUM IMPLANTS

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04707404
Enrollment
100
Registered
2021-01-13
Start date
2016-12-01
Completion date
2020-12-31
Last updated
2021-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries, Hematoma of Head, Skull Defect

Keywords

Cranioplasty, PEEK, Titanium, Outcomes, Complications, Subcutaneous effusion

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.

Interventions

PROCEDURECranioplasty

The surgery implanted artificial material to repair the skull defect.

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
ComplicationsDecember 2016 to December 2020Postoperative complications including Incision infection, Subcutaneous infection, Postoperative hematoma, Subcutaneous effusion, New seizure, Implants exposure and Implants removal.

Secondary

MeasureTime frameDescription
Postoperative cranial symmetryDecember 2016 to July 2020The postoperative cranial symmetry derived from the reconstruction of postoperative CT image.

Other

MeasureTime frameDescription
Postoperative improvement of GOSE scoreDecember 2016 to Decemeber 2020The GOSE score in 6-month follow-up compared with the GOSE score in admission
Postoperative feelingsMay 2017 to Decemeber 2020The subjective feelings for cranioplasty effect including 5 degrees of satisfaction and the Glasgow Benefit Inventory Score

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026