Polyethylene-Based Knee Spacer for Infection Control: Design Concept and Pre-Clinical In Vitro Validations.

Antibiotic-loaded polymethyl methacrylate (PMMA) has been widely applied in the treatment of knee periprosthetic joint infections. However, problems with antibiotic-loaded PMMA-based spacers, such as structural fracture and implant dislocation, remain unresolved. A novel polyethylene-based spacer, designed with an ultra-congruent articulating surface and multiple fenestrations, was introduced in the current study. Validation tests for biomechanical safety, wear performance, and efficacy of antibiotic cement were reported. During cycle fatigue testing, no tibial spacer failures were observed, and less wear debris generation was reported compared to commercial PMMA-based spacers. The volumetric wear of the novel spacer was within the safety threshold for osteolysis-free volumetric wear. An effective infection control was demonstrated despite the application of lesser antibiotic cement in the 30-day antibiotic elution test. The tube dilution test confirmed adequate inhibitory capabilities against pathogens with the loaded antibiotic option utilized in the current study. The novel polyethylene-based knee spacer may offer sufficient biomechanical safety and serve as an adequate carrier of antibiotic-loaded cement for infection control. Further clinical trials shall be conducted for more comprehensive validation of the novel spacer for practical application.