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生物活性玻璃S53P4作为骨移植替代物治疗慢性骨髓炎和感染性骨不连——50例患者的回顾性研究

The Use of Bioactive Glass S53P4 as Bone Graft Substitute in the Treatment of Chronic Osteomyelitis and Infected Non-Unions - a Retrospective Study of 50 Patients.

作者信息

Malat Tarek Al, Glombitza Martin, Dahmen Janosch, Hax Peter-Michael, Steinhausen Eva

机构信息

Klinik für Orthopädie und Unfallchirurgie, BG Klinikum Duisburg.

Department für Humanmedizin, Fakultät für Gesundheit, Universität Witten/Herdecke, Witten.

出版信息

Z Orthop Unfall. 2018 Apr;156(2):152-159. doi: 10.1055/s-0043-124377. Epub 2018 Apr 17.

DOI:10.1055/s-0043-124377
PMID:29665602
Abstract

BACKGROUND

Treatment of chronic osteomyelitis (COM) remains challenging and often results in large bone defects. Dead space management and proper defect filling are essential for successful treatment. Bioactive glass S53P4 (BAG-S53P4) is an anorganic bone graft substitute with antibacterial, osteoconductive, osteostimulative and angiogenic properties. The aim of our study was to analyse the outcome of patients with COM and infected non-unions, whose bone defects were filled with BAG-S53P4.

MATERIAL AND METHODS

In this retrospective study (07/13 - 02/16), we analysed all patients with COM and infected non-unions, who obtained BAG-S53P4 after surgical debridement to fill their bone defects. Epidemiological data, pre-, peri- and postoperative characteristics were evaluated. The primary endpoint was the successful control of infection during the follow-up period. Secondary endpoints were the absence of BAG-S53P4-related complications, the time period to full weight bearing as well as to radiologically detectable incorporation of BAG. X-ray examinations were routinely performed 1 month, 3 - 4 months, 6 months and 12 months postoperatively.

RESULTS

50 patients were analysed. Staphylococcus aureus was the most common pathogen involved. On average, 11.1 ± 6.7 cm BAG-S53P4 were implanted. Mean follow-up was at 12.3 months. After 6 months, 26/37 (70.3%) and after 12 months, 35/42 (83.3%) of the filled bone defects were healed. X-ray examinations showed a thickened neo-cortex. 40 patients (80%) have achieved full weight bearing after a mean of 4 months. There were no complications at all in 76% of patients. Seven patients suffered reinfection. BAG-associated complications were not seen.

CONCLUSIONS

The use of BAG-S53P4 in patients with COM and infected non-unions is promising. Adequate debridement and proper defect filling are necessary. BAG is well tolerated. X-ray examinations showed a thickened neo-cortex. The antibacterial effect is not mediated by antibiotics and is advantageous in times of evolving antibiotic resistance. High quality studies with a longer follow-up are required.

TRIAL REGISTRATION

TRN DRKS00011679.

摘要

背景

慢性骨髓炎(COM)的治疗仍然具有挑战性,且常常导致大的骨缺损。死腔管理和适当的缺损填充对于成功治疗至关重要。生物活性玻璃S53P4(BAG-S53P4)是一种具有抗菌、骨传导、骨刺激和血管生成特性的无机骨移植替代物。我们研究的目的是分析骨缺损用BAG-S53P4填充的COM和感染性骨不连患者的治疗结果。

材料与方法

在这项回顾性研究(2013年7月 - 2016年2月)中,我们分析了所有接受手术清创后使用BAG-S53P4填充骨缺损的COM和感染性骨不连患者。评估了流行病学数据、术前、术中和术后特征。主要终点是随访期间感染的成功控制。次要终点是无BAG-S53P4相关并发症、完全负重的时间以及影像学上可检测到的BAG植入时间。术后1个月、3 - 4个月、6个月和12个月常规进行X线检查。

结果

分析了50例患者。金黄色葡萄球菌是最常见的病原体。平均植入11.1±6.7 cm的BAG-S53P4。平均随访12.3个月。6个月后,37例中有26例(70.3%)填充的骨缺损愈合,12个月后,42例中有35例(83.3%)愈合。X线检查显示新生骨皮质增厚。40例患者(80%)平均在4个月后实现完全负重。76%的患者无任何并发症。7例患者再次感染。未观察到与BAG相关的并发症。

结论

在COM和感染性骨不连患者中使用BAG-S53P4前景良好。充分清创和适当的缺损填充是必要的。BAG耐受性良好。X线检查显示新生骨皮质增厚。抗菌作用不是由抗生素介导的,在抗生素耐药性不断演变的时代具有优势。需要进行随访时间更长的高质量研究。

试验注册

TRN DRKS00011679

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