The Role of Helmet Therapy in Craniosynostosis: A Systematic Review.

The aim of this study was to determine the impact of helmet therapy (HT) as a treatment for craniosynostosis, with a focus on the outcomes of skull morphology, reoperation rate, complications of HT, and quality of life of patients who receive it. A systematic literature review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The review utilized the PICO format: Does HT following strip craniectomy (SC) improve outcomes (outcome) compared to SC alone (comparison) in patients undergoing craniosynostosis correction (intervention)? Searches were performed from January 1, 2000 to December 31, 2022, using PubMed, Cochrane Library, and Ovid Medline databases. Study quality was evaluated using the National Heart, Lung, and Blood Institute (NHLBI) quality assessment scale. Fourteen studies meeting the inclusion criteria were identified. Among these, 438 patients underwent SC-HT, while 104 patients underwent SC without HT. The preoperative cephalic indices for sagittal craniosynostosis in the HT and non-HT groups were 66.8 and 67.8, respectively, which improved postoperatively to 75 and 76.2, respectively. Limited long-term follow-up hindered a definitive assessment of reoperation rates. Complication rates related to HT were low at approximately 2.9%, primarily consisting of skin irritation. Parental satisfaction was high, correlating with a strong compliance rate. Existing literature does not demonstrate a clear superiority between SC with or without HT for treating nonsyndromic sagittal craniosynostosis. Outcomes appear comparable, but evidence is constrained by the predominance of single-center retrospective studies with limited methodological rigor. There is a pressing need for international multicenter trials to furnish more robust and generalizable findings.