Shirai Toshiharu, Tsuchiya Hiroyuki, Nishida Hideji, Yamamoto Norio, Watanabe Koji, Nakase Junsuke, Terauchi Ryu, Arai Yuji, Fujiwara Hiroyoshi, Kubo Toshikazu
Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, Kanazawa, Japan Department of Orthopaedics, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan.
Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, Kanazawa, Japan
J Biomater Appl. 2014 Oct;29(4):617-23. doi: 10.1177/0885328214539365. Epub 2014 Jun 9.
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.
与植入物相关的深部感染仍然是骨科手术的严重并发症。我们开发了用于钛植入物的碘涂层。在本研究中，我们对碘涂层大假体进行了临床试验，以评估其安全性和抗菌效果。2008年7月至2013年5月期间，47例患有恶性骨肿瘤或化脓性关节炎的患者接受了碘负载钛大假体治疗。平均年龄为53.6岁（范围15 - 85岁）。男性26例，女性21例。诊断包括恶性骨肿瘤29例、感染性全膝关节置换术11例、化脓性关节炎所致慢性骨髓炎6例、全膝关节置换术松动1例。使用的碘负载植入物有42个京瓷肢体挽救系统和5个神户制钢K-MAX K-3。这些大假体用于21例患者预防感染，26例患者治疗活动性感染。平均随访期为30.1个月（范围8 - 50个月）。21例患者中有20例预防了感染。仅1例患者发生铜绿假单胞菌引起的手术部位感染，仅通过静脉注射抗生素治愈，未取出植入物。在26例涉及一期或二期翻修手术的治疗病例中，感染消退，无需额外手术。所有病例在最后一次随访时均无感染迹象。术后四周内白细胞和C反应蛋白水平恢复正常。为确认碘的全身作用，检测了血液中的甲状腺激素水平。未检测到甲状腺功能异常。未观察到植入物松动。在碘负载大假体周围发现了良好的骨长入和骨附着。碘负载钛大假体在预防和治疗大骨缺损感染方面非常有效且前景良好。该治疗未检测到细胞毒性或不良反应。
