The largest clinically based data collection on CustomBone Service cranioplasty (687 implants) with a long Follow-up

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The Journal of Clinical Medicine has published an important study with the largest clinically based data collection on our CustomBone Service cranioplasty (687 implants) with a long follow-up.

The paper titled “Long-Term Follow-Up of Custom-Made Porous Hydroxyapatite Cranioplasties: Analysis of Infections in Adult and Pediatric Patients” is aimed to define the scenario in which infections develop after cranioplasty with CustomBone Service.

The study includes 687 patients (with 80 patients of pediatric age, less than 14 y.o.) who underwent PHA cranioplasty (CustomBone Service) whose clinical data were collected in the Post Clinical Market Follow up (PMCF) database from Finceramica. Data were collected across 26 neurosurgical centers in five European countries.

The average follow-up period was 25.6 months, from 6 to 60 months. Infections were reported by 41 patients (6% of the total). Specifically, 3.8% developed infection within 2 months after CP (early infections), while only 2.2% were reported after 2 months from CP (late infections).

Analyses performed using the Kaplan–Meier method has shown that 94% of all patients remained infection-free, with the remaining 6% experiencing an infection. Interestingly, 2/3 of patients who developed infections did so within the initial 6 months following cranioplasty.

In the pediatric group, 40% of infections happened within the first month post CP, while the remainder occurred after the second month (Figure 2).

Another factor affecting infection occurrence was the type of decompression (Figure 3): bifrontal decompression was more prone to infections (12.5%) than unilateral fronto-temporoparietal decompression (5.1%). Bifrontal cranial decompression should be avoided whenever possible since this technique carries a higher risk of infections over time.

Among the 522 patients in the first-line treatment category, 29 (5.6%) developed infections, with an average onset time of 16 months. In the second-line treatment group comprising 165 patients, 12 individuals (7.3%) experienced infections, with an average onset time of 10 months (Figure 4).

References:

[1] Francesca Carolina Mannella, Francesca Faedo, Marta Fumagalli, Giuseppe Danilo Norata, Ismail Zaed and Franco Servadei “Long-Term Follow-Up of Custom-Made Porous Hydroxyapatite Cranioplasties: Analysis of Infections in Adult and Pediatric Patients” (https://pubmed.ncbi.nlm.nih.gov/38398446/) Journal of Clinical Medicine, February 2024