Abstract
BACKGROUND: Bacteriophages, or simply phages, are viruses that specifically infect and lyse bacteria. As antibiotic resistance becomes a growing global concern, phage therapy is gaining renewed attention as a targeted and effective treatment option. In orthopedics and trauma surgery-disciplines characterized by high rates of chronic and implant-associated infections-phages offer promising new therapeutic avenues, particularly in cases involving multidrug-resistant pathogens or when conventional surgery is limited. CURRENT DEVELOPMENTS: Originally developed in the early 20th century, phage therapy lost prominence with the rise of antibiotics. Today, case studies and emerging clinical protocols-especially in the context of periprosthetic joint infections-demonstrate the potential of personalized phage cocktails and advanced delivery systems, such as hydrogels or intra-articular injections. Their specificity enables bacterial eradication while sparing the host microbiome. REGULATORY SITUATION: However, the regulatory landscape in the European Union poses significant challenges. Phages are classified as biological medicinal products, requiring comprehensive preclinical and clinical evaluation. While magistral production and compassionate use permit individual applications, broad clinical integration demands standardized protocols, accessible phage libraries, and robust quality control. Furthermore, safety concerns, including immunogenicity and systemic distribution, must be addressed through structured research. CONCLUSION: To fully realize the potential of phage therapy in orthopaedic infection management, interdisciplinary collaboration, targeted funding, and clinical trials are essential. Responsible implementation within expert centers can ensure efficacy and safety, paving the way for a controlled and evidence-based adoption of phages as a complementary strategy alongside traditional surgical and antibiotic treatments.