Schmidmaier Gerhard, Lucke Martin, Wildemann Britt, Haas Norbert P, Raschke Michael
Centrum für Muskuloskeletale Chirurgie, Charité-Universitätsmedizin Berlin, Germany.
Injury. 2006 May;37 Suppl 2:S105-12. doi: 10.1016/j.injury.2006.04.016.
Implant-related infection is a feared complication in orthopedic and trauma surgery with tremendous consequences for the patient. To reduce this risk, administration of perioperative antibiotic prophylaxis is a routine procedure in orthopedic surgery. A local delivery system for antibiotics based on a polymer implant coating has been developed to optimize the prophylaxis. In an animal experiment, the efficacy of local prophylaxis of gentamicin was compared to a systemic single shot of gentamicin and to a combination of both administrations. The medullary cavities of rat tibiae were contaminated with Staphylococcus aureus and titanium K-wires were implanted into the medullary canals. For local antibiotic therapy, the implants were coated with poly(D,L-Lactide) (PDLLA) loaded with gentamicin. All the animals not treated with local and systemic application of the antibiotic developed osteomyelitis and all cultures of the implants tested positive for S. aureus. Onset of infection was prevented in 80-90% of animals treated with gentamicin-coated K-wires, with and without systemic prophylaxis. Gentamicin-coated intramedullary tibial nails are CE-certified for Europe and Canada and several patients have already been treated for implant-related infection. Up to now, eight patients with open tibia fractures have been treated with an unreamed tibial nail (UTN) coated with PDLLA and gentamicin. In the 1-year follow up, none of the patients developed an infection. A prospective randomized clinical documentation is currently in progress. So far, the results suggest that a local application of gentamicin from PDLLA-coated implants might support systemic antibiotic prophylaxis in preventing implant-associated osteomyelitis.
植入物相关感染是骨科和创伤外科令人担忧的并发症，会给患者带来严重后果。为降低这种风险，围手术期预防性使用抗生素是骨科手术的常规操作。一种基于聚合物植入物涂层的抗生素局部递送系统已被开发出来以优化预防措施。在一项动物实验中，将庆大霉素局部预防的效果与全身单次注射庆大霉素以及两种给药方式联合使用的效果进行了比较。将大鼠胫骨的髓腔用金黄色葡萄球菌污染，并将钛克氏针植入髓管。对于局部抗生素治疗，将载有庆大霉素的聚（D，L - 丙交酯）（PDLLA）涂覆在植入物上。所有未接受抗生素局部和全身应用治疗的动物均发生骨髓炎，并且所有植入物培养物检测金黄色葡萄球菌均呈阳性。在接受庆大霉素涂层克氏针治疗的动物中，无论有无全身预防措施，80 - 90%的动物感染发作得到预防。庆大霉素涂层胫骨髓内钉在欧洲和加拿大已获得CE认证，并且已有数名患者接受了植入物相关感染的治疗。到目前为止，8例开放性胫骨骨折患者接受了涂有PDLLA和庆大霉素的非扩髓胫骨髓内钉（UTN）治疗。在1年的随访中，没有患者发生感染。一项前瞻性随机临床记录目前正在进行中。到目前为止，结果表明从PDLLA涂层植入物局部应用庆大霉素可能有助于全身抗生素预防以防止植入物相关骨髓炎。
