Page 110 - Clinical relevance of current materials for cranial implants

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Chapter 5
Preoperative planning
Computed tomography (CT) scans of the cranium were acquired using a high-resolution protocol as required for preoperative 3D planning and design of the PEEK implant (Xilloc Medical BV, Maastricht, the Netherlands, 29 cranioplasties; DePuy Synthes, Zuchwil, Switzerland, 7 cranioplasties; 3di GmbH, Jena, Germany, 4 cranioplasties).
Surgical procedure
Prophylactic antibiotics (intravenous Cefazolin 2000 mg) were administered 30 minutes before incision. A skin flap was raised and if present, an autologous bone flap or PMMA PSI was removed. After dural exposure the bony edges of the skull defect were exposed to fit the PEEK PSI (Figure 1). Pre-formed holes in the PSI were used for dural tack-up sutures. In recent PEEK cranioplasties, the need for additional miniplate fixation could be eliminated with the tangential InterFix technology (Xilloc), in which case the screws were tangentially directed into the bone edges. If indicated, the temporal muscle was suspended to the PSI through the pre-formed holes. In selected cases a subgaleal drain was placed. There was no consensus about the placement of a drain, so the decision was left to the preference of the surgeon and the present conditions. The skin was closed in two layers and a circumferential pressure bandage was applied. All patients underwent standard postoperative care.
Statistical analysis
Categorical data are presented as absolute values and percentages, continuous, normally distributed data as means and standard deviations (SD), while time intervals are presented as medians and interquartile ranges (IQR). Potential risk factors associated with complications after the use of PSI were extracted with Chi-square tests. A p-value ≤ 0.05 was considered statistically significant. Data analysis was performed using SPSS 23.0.