BACKGROUND: Currently, various materials are routinely used for cranioplasty after decompressive craniectomy, each with their own features, potential benefits, and harms.
OBJECTIVES: To systematically review available literature about safety (infection, resorption, and removal) of different materials used for cranioplasty for any indication.
METHODS: A comprehensive search in MEDLINE, EMBASE and the Cochrane library was performed for relevant studies published up to January 2017. Study quality was assessed according to the Cochrane Collaboration risk of bias assessment tool and a set of 27 predetermined parameters was extracted by two investigators independently for further analysis.
RESULTS: The search yielded two randomized, 14 prospective and 212 retrospective studies, totaling 10,346 cranioplasties in which 1,952 (18.9%) complications were reported in patients between 0 and 90 years old. Overall, study quality was low and heterogeneity was large. Graft infections and resorption were most prevalent: overall infection rate was 5.6%. Autologous cranioplasties showed an infection rate of 6.9% vs. 5.0% in combined alloplastic materials, including PMMA with 7.8%. Resorption occurred almost exclusively in autologous cranioplasties (11.3%). The highest removal rate was reported for autologous cranioplasties (overall: 10.4%), which was significantly higher than that of combined alloplastic materials (overall: 5.1%);RD=0.052 (95%CI:0.039-0.066);NNT=19 (95%CI:15-25).
CONCLUSION: Available evidence on the safety of cranioplasty materials is limited due to a large diversity in study conduct, patients included and outcomes reported. Autologous bone grafts appear to carry a higher failure risk than allografts. Future publications concerning cranioplasties will benefit by a standardized reporting of surgical procedures, outcomes and graft materials used.