Therapeutic efficacy of vancomycin-loaded carbon fiber-reinforced polyetheretherketone hip stem for periprosthetic joint infection: A pilot study.

A carbon fiber-reinforced polyetheretherketone (CFR/PEEK) hip stem with a special antibiotic elution mechanism is under development to treat periprosthetic joint infection (PJI). The antibiotic elution characteristics of intramedullary implants were experimentally investigated, and the efficacy of revision surgery using a therapeutic stem in treating ovine PJI was examined. To evaluate elution characteristics, the intramedullary vancomycin-loaded CFR/PEEK cylindrical implants were inserted in the distal femur of nine sheep, and the vancomycin elution rate was measured at 2, 7, and 21 days. To evaluate therapeutic efficacy, the PJI model with staphylococcus aureus was attempted to create for five sheep. Moreover, the therapeutic vancomycin-loaded CFR/PEEK stem was implanted during one-stage revision surgery. Three weeks after revision surgery, the treatment efficacy was evaluated based on bacterial cultures and wound findings. In addition, the vancomycin elution rate from the stem was measured. On average, the cylindrical implants eluted approximately 70% vancomycin in 21 days. Of the five sheep attempting to create a PJI model, three were successfully infected with S. aureus as intended for verification of treatment efficacy. In all three joints, negative bacterial cultures and no purulence were observed 3 weeks after revision surgery. The vancomycin elution rates from the stems were >70%. Efficient elution of vancomycin was confirmed by the experimental implant inserted into the bone marrow and the stem in actual PJI treatment. Using a novel therapeutic stem with an antibiotic elution mechanism in one-stage revision surgery, successful treatment was demonstrated in all S. aureus-induced PJIs.

Optimizing vancomycin release from novel carbon fiber-reinforced polymer implants with small holes: periprosthetic joint infection treatment.

Periprosthetic joint infection (PJI) is a catastrophic complication after total hip arthroplasty. A new drug-loaded carbon fiber-reinforced polymer (CFRP) prosthesis with a sustained drug-release mechanism is being developed for one-stage surgery. We aimed to examine the diffusion dynamics of vancomycin from vancomycin paste-loaded CFRP implants. The differences in the in vitro diffusion dynamics of vancomycin paste were investigated using the elution test by varying parameters. These included the mixing ratio of vancomycin and distilled water (1:0.8, 1:1.2, and 1:1.4) for vancomycin paste, and hole diameter (1 mm and 2 mm) on the container. The in vivo diffusion dynamics were investigated using a rabbit model with vancomycin-loaded CFRP implants placed subcutaneously. The in vitro experiments showed that the diffusion effect of vancomycin was highest in the parameters of vancomycin paste with distilled water mixed in a ratio of 1:1.4, and with a 2 mm hole diameter. The in vivo experiments revealed diffusion dynamics similar to those observed in the in vitro study. The drug diffusion effect tended to be high for vancomycin paste with a large water ratio, and a large diameter of holes. These results indicate that the drug diffusion dynamics from a CFRP implant with holes can be adjusted by varying the water ratio of the vancomycin paste, and the hole size on the CFRP implant.

Osteocompatibility of Si3N4-coated carbon fiber-reinforced polyetheretherketone (CFRP) and hydroxyapatite-coated CFRP with antibiotics and antithrombotic drugs.

This study used a rabbit model to investigate the osteocompatibility of Si3N4-coated carbon fiber-reinforced polyetheretherketone (CFRP) and hydroxyapatite (HA)-coated CFRP with antibiotics (vancomycin [VCM]) and antithrombotic drugs (polyvinylpyrrolidone [PVP]). HA-coated cylindrical CFRP implants were used as the controls (HA), and HA-coated implants treated with VCM and PVP were prepared (HA-VP) as the test groups; a cylindrical CFRP coated with Si3N4 was also prepared (SiN). Ten implants from each group were randomly inserted into the femoral diaphysis of rabbits. The pull-out test, radiological analysis using micro-computed tomography (µ-CT), and histological analysis were performed. The pull-out strength of the SiN group was lower than that of the HA group. µ-CT analysis revealed that the amount of bone formation around the implant in the SiN group was inferior to that in the HA group. Conversely, the HA-VP group had equivalent pull-out strength and bone formation as analyzed by µ-CT compared to the HA group. In conclusion, the additional surface treatment of the HA-coated CFRP with VCM and PVP provided sufficient bone fixation and formation.