The use of gentamicin-coated nails in the tibia: preliminary results of a prospective study.
The use of gentamicin-coated nails in the tibia: preliminary results of a prospective study.
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DOI：
10.1007/s00402-011-1321-6
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发表时间：
2011-10
影响因子：
2.3
通讯作者：
Raschke MJ
中科院分区：
文献类型：
--
作者：
Fuchs T;Stange R;Schmidmaier G;Raschke MJ
在手术治疗胫骨干骨折后，使用骨涂层植入物可降低感染率并促进骨折愈合。2005年8月，一种新的植入物生物可降解庆大霉素涂层（UTN PROtect®）获得CE认证。在该前瞻性、非随机病例系列中，我们研究了21例接受闭合性或开放性胫骨骨折手术治疗以及使用不扩髓胫骨髓内钉PROtect®庆大霉素涂层髓内钉翻修的患者的临床、实验室和影像学结局。21例患者（13例男性，8例女性）中，19例完成了6个月随访。研究人群包括复杂胫骨骨折患者和晚期翻修病例。临床结局包括不良事件，包括感染和SF-36身体评分。实验室结果，包括C-反应蛋白和白细胞计数作为炎症标志物，血红蛋白和血清庆大霉素，测量基线和术后6个月。在术后5周、3个月和6个月测定骨折愈合和负重能力的放射学评估。未发生植入物相关感染; 1例患者出现浅表伤口愈合问题。在整个研究期间，平均C反应蛋白水平保持在5 mg/L以下，在术后4-7天达到峰值（4.4 mg/L;范围0.5-16.1 mg/L）。研究期间，白细胞计数和血红蛋白水平未随时间变化。6个月时的平均SF-36身体评分为42.6（范围19.4-56.7）。6个月后，11例患者（58%）实现了影像学愈合，定义为3个或4个桥接皮质。其余8例患者显示部分骨折愈合，有1个或2个桥接皮质。此外，13名患者（68%）在6个月后表现出完全负重能力。6个月后，使用不扩髓的胫骨髓内钉PROtect®髓内钉与良好的临床、实验室和影像学结局相关。这些初步结果支持使用庆大霉素涂层植入物作为预防创伤患者和翻修病例感染的一种新的潜在治疗选择。二级。
The use of antibiotic-coated implants may reduce the rate of infection and facilitate fracture healing after surgical treatment of tibial shaft fractures. A new biodegradable gentamicin-loaded coating of an implant (UTN PROtect®) was CE-certified in August 2005. In this prospective, non-randomized case series, we investigated the clinical, laboratory and radiological outcomes of 21 patients who underwent surgical treatment in closed or open tibial fractures, as well as revisions with the UTN PROtect® gentamicin-coated intramedullary nail. Of 21 patients (13 men, 8 women), 19 completed the 6-month follow-up. The study population included patients with complex tibial fractures and late revision cases. Clinical outcomes comprised adverse events, including infections and the SF-36 physical score. Laboratory outcomes, including C-reactive protein and leukocyte count as inflammatory markers, haemoglobin and serum gentamicin, were measured at baseline and up to 6 months post operatively. Radiographic assessments of fracture healing and weight-bearing capacity were determined at 5 weeks, 3 and 6 months after surgery. No implant-related infections occurred; one patient had superficial wound healing problems. Mean C-reactive protein levels remained below 5 mg/L throughout the study, with a peak at 4–7 days after surgery (4.4 mg/L; range 0.5–16.1 mg/L). Leukocyte counts and haemoglobin levels did not vary over time during the study. The mean SF-36 physical score at 6 months was 42.6 (range 19.4–56.7). Radiographic union defined as three or four bridged cortices was achieved in 11 patients (58%) after 6 months. The remaining eight patients showed partial fracture healing with one or two bridged cortices. Additionally, 13 patients (68%) demonstrated full weight-bearing capacity after 6 months. The use of the UTN PROtect® intramedullary nail was associated with good clinical, laboratory and radiological outcomes after 6 months. These preliminary results support the use of gentamicin-coated implants as a new potential treatment option for the prevention of infection in trauma patients and in revision cases. Level II.
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影响因子：
3
作者：
Ware, JE
通讯作者：
Ware, JE
影响因子：
7.2
作者：
Busse, Jason W.;Bhandari, Mohit;Walter, Stephen D.
通讯作者：
Walter, Stephen D.
影响因子：
4.1
作者：
Lucke, M;Schmidmaier, G;Raschke, M
通讯作者：
Raschke, M
影响因子：
2.3
作者：
Gaebler, C;Berger, U;Vécsei, V
通讯作者：
Vécsei, V
DOI：
10.1016/j.injury.2006.04.016
发表时间：
2006-05-01
影响因子：
2.5
作者：
Schmidmaier, Gerhard;Lucke, Martin;Raschke, Michael
通讯作者：
Raschke, Michael