Serrier Hassan, Huot Laure, Brosset Sophie, Batailler Cécile, Ferry Tristan
Health Economic Evaluation Service, Hospices Civils de Lyon, Lyon, France.
Université Claude Bernard Lyon 1, Research on Healthcare Performance RESHAPE, Lyon, France.
Front Med (Lausanne). 2023 Mar 30;10:1116711. doi: 10.3389/fmed.2023.1116711. eCollection 2023.
Chronic osteomyelitis is a serious osteoarticular infection that most often occurs in the long bones, responsible for significant morbidity with the risk of fracture and amputation. Despite advances in both antibiotics and surgical treatment, the probability of recurrence of infection remains at around 20%. Cerament-G (BONESUPPORT AB, Sweden) is a synthetic bone substitute that fills the bone void left by surgery, prevents infection and promotes bone regeneration within this space. Cerament-G also provides the local delivery of high doses of gentamicin over several weeks. Two prospective observational studies described a number of infectious recurrences of 4 and 5% after the use of Cerament-G. Although available in France, Cerament-G is currently not reimbursed and its high cost constitutes a barrier to its use. We hypothesize that the use of Cerament-G will lead to fewer costs to the collectivity while improving patient utility and, as an innovative strategy, will be superior to standard of care on recurrence of infection.
The Conviction Study is a prospective, multicenter, randomized, single blind study conducted in 14 French Reference Centers for Complex Osteoarticular infections. The main objective is to evaluate the cost-effectiveness of using Cerament-G in the treatment of chronic long bone osteomyelitis by comparing this innovative strategy to standard of care. A cost-utility analysis from the collective perspective will be conducted over a 24-month time horizon after the initial surgery. The outcome for the main medico-economic evaluation will be Quality Adjusted Life Years (QALYs).
The study is being conducted throughout the CRIOAc network in France, in referral centers for the management of complex infections which will facilitate patient recruitment. This study has several limitations: the investigators have to be trained to handle the device, and it was impossible to blind the surgeon.
If the use of Cerament-G is demonstrated to be superior to leaving the dead space empty during surgery for patients with stage III chronic long bone osteomyelitis, its use will be recommended to improve the prognosis of such patients, and this device may eventually qualify for reimbursement through the French Health Insurance scheme.
This protocol received authorization from the Ethics Committee CPP Sud Méditerranée V on April 27, 2021 (21.03.10.77652) and the French National Agency for Medicines and Health Products on May 6, 2021 (2020-A02299-30). Results will be disseminated to the scientific community through congresses and publication in peer-reviewed journals.
慢性骨髓炎是一种严重的骨与关节感染，最常发生于长骨，可导致严重的发病情况，并伴有骨折和截肢风险。尽管抗生素和外科治疗都有了进展，但感染复发的概率仍维持在20%左右。Cerament-G（瑞典BONESUPPORT AB公司）是一种合成骨替代物，可填充手术遗留的骨缺损，预防感染并促进该区域的骨再生。Cerament-G还能在数周内实现高剂量庆大霉素的局部递送。两项前瞻性观察性研究描述了使用Cerament-G后感染复发率分别为4%和5%。尽管Cerament-G在法国有售，但目前尚未纳入医保报销范围，其高昂的成本成为了使用障碍。我们推测，使用Cerament-G将降低集体成本，同时提高患者效用，作为一种创新策略，在感染复发方面将优于标准治疗。
Conviction研究是一项在14个法国复杂骨与关节感染参考中心进行的前瞻性、多中心、随机、单盲研究。主要目的是通过将这种创新策略与标准治疗进行比较，评估使用Cerament-G治疗慢性长骨骨髓炎的成本效益。在初次手术后的24个月时间范围内，将从集体角度进行成本效用分析。主要医学经济学评估的结果将是质量调整生命年（QALYs）。
该研究在法国整个CRIOAc网络的复杂感染管理转诊中心开展，这将便于患者招募。本研究有几个局限性：研究人员必须接受培训以操作该装置，而且不可能对外科医生设盲。
如果证明对于III期慢性长骨骨髓炎患者，使用Cerament-G优于手术时留空死腔，那么将建议使用它来改善此类患者的预后，并且该装置最终可能有资格通过法国医疗保险计划获得报销。
本方案于2021年4月27日获得地中海沿岸法国南部CPP伦理委员会（21.03.10.77652）以及2021年5月6日获得法国国家药品和保健品管理局（2020 - A02299 - 30）的批准。研究结果将通过学术会议和在同行评审期刊上发表传播给科学界。
