Safety and Efficacy of S53P4 Bioactive Glass in Osteomyelitis Management: A Systematic Review and Meta-Analysis.

Osteomyelitis remains a difficult-to-treat bone infection due to its high recurrence risk, complex surgical demands, and rising rates of multidrug-resistant organisms. While conventional treatments rely heavily on antibiotic-loaded materials, bioactive glass S53P4 offers a dual-action alternative, combining bacteriostatic and bactericidal activity with bone regenerative potential. A systematic review and meta-analysis following PRISMA guidelines was conducted to evaluate the clinical efficacy and safety of S53P4 bioactive glass in osteomyelitis treatment. Twenty-eight studies published between 2000 and 2024, encompassing 1122 patients (mean age: 43.6 years), were included. Outcomes analyzed included infection eradication, recurrence, bone healing, functional recovery, and complications. The risk of bias was assessed using ROBINS-I for observational studies and the JBI checklist for case series. A meta-analysis of 10 studies reporting infection eradication at ≥ 12 months was performed using a random-effects model. The pooled infection eradication rate was 88.1% (95% CI: 85.4%-90.4%) with no significant heterogeneity (I = 0%). Studies reported consistent efficacy across chronic, diabetic foot, mastoid, and jaw osteomyelitis. S53P4 was effective against polymicrobial and multidrug-resistant infections, including Staphylococcus aureus and Pseudomonas aeruginosa. Healing outcomes were favorable, with high rates of bone integration and return to function. Complications were uncommon and primarily related to soft tissue coverage. Most patients received systemic antibiotics; no studies required local antibiotic-loaded materials alongside S53P4. Bioactive glass S53P4 is a safe and effective adjunct in osteomyelitis management, demonstrating high long-term infection control, robust bone regeneration, and a low complication profile. Its nonantibiotic antimicrobial mechanism makes it particularly suitable in settings of antimicrobial resistance. Future studies should assess its long-term durability and applications in high-risk infections.