Faculty of Health Science, VID Specialized University, Bergen, Norway
The Norwegian Arthroplasty Register, Department of Orthopedic Surgery, Haukeland University Hospital, Bergen, Norway.
BMJ Open. 2021 Jan 28;11(1):e041096. doi: 10.1136/bmjopen-2020-041096.
The current evidence on the efficacy of antibiotic-loaded bone cement (ALBC) in reducing the risk of periprosthetic joint infections (PJI) after primary joint reconstruction is insufficient. In several European countries, the use of ALBC is routine practice unlike in the USA where ALBC use is not approved in low-risk patients. Therefore, we designed a double-blinded pragmatic multicentre register-based randomised controlled non-inferiority trial to investigate the effects of ALBC compared with plain bone cement in primary total knee arthroplasty (TKA).
A minimum of 9,172 patients undergoing full-cemented primary TKA will be recruited and equally randomised into the ALBC group and the plain bone cement group. This trial will be conducted in Norwegian hospitals that routinely perform cemented primary TKA. The primary outcome will be risk of revision surgery due to PJI at 1-year of follow-up. Secondary outcomes will be: risk of revision due to any reason including aseptic loosening at 1, 6, 10 and 20 years of follow-up; patient-related outcome measures like function, pain, satisfaction and health-related quality of life at 1, 6 and 10 years of follow-up; risk of changes in the microbial pattern and resistance profiles of organisms cultured in subsequent revisions at 1, 6, 10 and 20 years of follow-up; cost-effectiveness of routine ALBC versus plain bone cement use in primary TKA. We will use 1:1 randomisation with random permuted blocks and stratify by participating hospitals to randomise patients to receive ALBC or plain bone cement. Inclusion, randomisation and follow-up will be through the Norwegian Arthroplasty Register.
The trial was approved by the Western Norway Regional Committees on Medical and Health Research Ethics (reference number: 2019/751/REK vest) on 21 June 2019. The findings of this trial will be disseminated through peer-reviewed publications and conference presentations.
NCT04135170.
目前关于抗生素骨水泥（ALBC）在降低初次关节重建后假体周围关节感染（PJI）风险方面的疗效的证据不足。在一些欧洲国家，使用 ALBC 是常规做法，而在美国，低危患者不批准使用 ALBC。因此，我们设计了一项双盲实用多中心基于登记的随机对照非劣效性试验，以调查 ALBC 与普通骨水泥在初次全膝关节置换术（TKA）中的效果。
将招募至少 9172 例接受全水泥初次 TKA 的患者，并将其平均随机分为 ALBC 组和普通骨水泥组。该试验将在挪威常规行水泥固定初次 TKA 的医院进行。主要结局为 1 年随访时因 PJI 而进行翻修手术的风险。次要结局为：1、6、10 和 20 年随访时因任何原因（包括无菌性松动）而进行翻修的风险；患者相关结局指标，如功能、疼痛、满意度和健康相关生活质量，在 1、6 和 10 年随访时；1、6、10 和 20 年随访时培养的微生物模式和耐药谱变化的风险；初次 TKA 中常规使用 ALBC 与普通骨水泥的成本效益。我们将采用 1:1 随机分组、随机排列块和按参与医院分层，将患者随机分为接受 ALBC 或普通骨水泥治疗。纳入、随机分组和随访将通过挪威关节置换登记处进行。
该试验于 2019 年 6 月 21 日获得了西部挪威地区医学和健康研究伦理委员会（参考号：2019/751/REK 西部）的批准。该试验的结果将通过同行评议的出版物和会议报告进行传播。
NCT04135170。
