Clinical trial NCT04707404: Comparison of Cranioplasty With PEEK and Titanium
Official title: COMPREHENSIVE EVALUATION FOR CRANIOPLASTY WITH POLYETHERETHERKETONE AND TITANIUM IMPLANTS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries
Hematoma of Head
Skull Defect
Keywords: Cranioplasty
PEEK
Titanium
Outcomes
Complications
Subcutaneous effusion
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients received cranioplasty with PEEK and titanium from December 2016 to July 2020 in 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complications
timeFrame: December 2016 to December 2020
Secondary outcomes:
measure: Postoperative cranial symmetry
timeFrame: December 2016 to July 2020
Other outcomes:
measure: Postoperative improvement of GOSE score
timeFrame: December 2016 to Decemeber 2020
measure: Postoperative feelings
timeFrame: May 2017 to Decemeber 2020
Locations:
Study officials:
References: