Antimicrobial megaprostheses supported with iodine

Abstract

Deep infection associated with implants remains a serious complication of orthopedic surgery. We developed iodine coating for titanium implants. In this study, we performed a clinical trial of iodine-coated megaprostheses to evaluate its safety and antibacterial effects. Forty-seven patients with malignant bone tumor or pyogenic arthritis were treated using iodine-supported titanium megaprostheses between July 2008 and May 2013. The mean age was 53.6 years (range, 15-85 years). Twenty-six patients were males and 21 were females. The diagnoses included malignant bone tumor in 29 cases, infected total knee arthroplasty in 11 cases, chronic osteomyelitis due to pyogenic arthritis in six cases and loosening of total knee arthroplasty in one case. The iodine-supported implants used were 42 Kyocera Limb Salvage System and five KOBELCO K-MAX K-3. These megaprostheses were used to prevent infection in 21 patients, treat active infections in 26 patients. The mean follow-up period was 30.1 months (range, 8-50). Infection was prevented in 20 out of 21 patients. Only one patient had surgical site infection caused by Pseudomonas aeruginosa and was cured by intravenous administration of antibiotics alone without removal of the implant. In 26 treatment cases involving one- or two-stage revision surgery, infection subsided without any additional surgery. In all cases, there were no signs of infection at the time of the last follow-up. White blood cell and C-reactive protein levels returned to normal within four weeks after surgery. To confirm systemic effects of iodine, thyroid hormone levels in the blood were examined. Abnormalities of thyroid gland function were not detected. Loosening of the implants was not observed. Excellent bone ingrowth and ongrowth were found around iodine-supported megaprostheses. The iodine-supported titanium megaprostheses are highly effective and show promise for the prevention and treatment of infections in large bone defects. No cytotoxicity or adverse effects were detected with this treatment.

Coatings as the useful drug delivery system for the prevention of implant-related infections

“…Other coating materials, such as iodine ions [109, 110], titanium oxide photocatalysis, nitric oxide, and graphene coating [111], have provided new ideas and alternative approaches for the prevention of IRIs.…”

“…Implants coated with iodine can be effective for preventing and treating IRIs. Two case series indicated that the rate of preventing or treating IRIs was over 95% with cytotoxicity and adverse effects [109, 110]. A summary of above mentioned clinical studies was listed in Table 1.…”

Local Antibacterial Implant Protection in Orthopedics and Trauma: What’s New?

“…Two more recent non-comparative studies -one investigating iodine coating and megaprosthesis [45], the other investigating total hip arthroplasty (THA) [46] -confirmed the safety and efficacy of the technology at longer follow-ups. Based on these findings, clinical trials are currently ongoing to meet the regulatory requirements for market approval (Fig.…”

New biomaterials for orthopedic implants

“…Iodine-coated megaprostheses have also been used in a clinical trial to treat patients with malignant bone tumor or pyrogenic arthritis. 182 In all cases, there were no signs of infection at the time of the last follow-up. Osseointegration was found around iodine-supported megaprostheses with no evidence of loosening.…”

“…The efficacy of iodine-supported Ti implants has also been shown in the management of patients with active infection ( Figure 5). 179,[181][182][183] Patients with pyogenic vertebral osteomyelitis were operated on using Ti spinal instrumentation with iodine-containing surfaces. 181 The infection subsided in all 14 patients, with both white blood cell count and C-reactive protein levels returning to normal ranges by the final follow-up.…”