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Abstract：
Background Cerament V (CV) is a bioactive bone graft substitute with vancomycin as an antimicrobial agent designed for the management of bone defects and infections. In this retrospective case series, we aim to evaluate the clinical outcomes of patients treated with CV for fracture-related infections (FRI). Methods All patients who received treatment for FRI and whose dead space and bone reconstruction management was solely done utilizing CV were included. The patients were recruited between September 2015 and September 2022. Data including patient demographics, primary diagnosis, surgical procedure, antibiotic therapy, microbiological results, complications, and follow-ups were recorded. Outcomes were assessed, including the percentage of bone void filling on radiographs, infection resolution, adverse effects, and patient-reported outcome measures by EQ-5D-5L. Results We present in this retrospective case series seven patients (three female) with a mean age of 56.86 ± 16.27 years. All patients underwent surgical debridement and bone grafting using CV. Antibiotic therapy was tailored to the specific pathogens isolated in each case. Infection eradication was achieved in five patients. On average, new bone formation was 81% at six months and 99% at 12 months. Patient-reported outcome parameters (PROMs) utilizing the EQ-5D-5L questionnaire were recorded at a mean follow-up of 42.00 ± 27.97 months with a median EQ-5D-5L index of 0.541 (range: 0.459 - 0.97) and a mean EQ-5D-Visual Analogue Scale (VAS) score of 62.20 ± 24.68. No major adverse events related to CV were reported. Conclusion This retrospective case series demonstrates the potential efficacy of CV in managing FRIs. The bioactive and antibiotic properties of CV appear to facilitate infection resolution and bone healing, with an advantageous safety profile. Larger prospective studies are needed to further investigate the utility of CV in orthopedic practice.
摘要：
背景CeramentV（CV）是一种生物活性骨移植替代品，万古霉素作为抗微生物剂，旨在治疗骨缺损和感染。在这个回顾性案例系列中，我们旨在评估接受CV治疗的骨折相关感染(FRI)患者的临床结局.方法纳入所有接受FRI治疗且仅使用CV进行死腔和骨重建处理的患者。这些患者在2015年9月至2022年9月之间招募。包括患者人口统计在内的数据，初步诊断,外科手术,抗生素治疗,微生物结果，并发症,并记录随访情况。对结果进行了评估，包括射线照片上骨空隙填充的百分比，感染分辨率，不利影响，和EQ-5D-5L患者报告的结果指标。结果我们在此回顾性病例系列中介绍了7例患者（3例女性），平均年龄为56.86±16.27岁。所有患者均采用CV进行手术清创和植骨。针对每种情况下分离的特定病原体定制抗生素治疗。5例患者实现了感染根除。平均而言,新骨形成在6个月时为81%,在12个月时为99%.在平均随访42.00±27.97个月时，使用EQ-5D-5L问卷记录患者报告的结果参数（PROMs），中位EQ-5D-5L指数为0.541（范围：0.459-0.97），平均EQ-5D-视觉模拟量表（VAS）评分为62.20±24.68。未报告与CV相关的重大不良事件。结论本回顾性病例系列证明了CV在治疗FRIs方面的潜在功效。CV的生物活性和抗生素特性似乎有助于感染消退和骨愈合，具有有利的安全性。需要更大的前瞻性研究来进一步研究CV在骨科实践中的实用性。
