Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
Orthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark.
BMC Musculoskelet Disord. 2021 Feb 12;22(1):175. doi: 10.1186/s12891-021-04044-8.
A two-stage prosthesis exchange procedure has been the gold standard in surgical treatment of the chronically infected knee arthroplasty so far. This includes 2 surgeries/hospitalizations and an interim period of 2-3 months between surgeries with impaired health, functional status and quality of life of the patients. A one-stage exchange procedure holds many obvious advantages compared to the two-stage approach, but outcomes of a one-stage versus two-stage procedures have never been investigated in a randomized clinical trial. The purpose of this study is primarily to investigate time-adjusted differences in functional status of patients after one-stage versus two-stage revision. Secondary, to report time-adjusted differences in quality of life, complications (including re-revisions due to infection) and mortality.
This study is a pragmatic, multi-center, randomized, non-inferiority trial comparing one-stage versus two-stage revision of the infected knee arthroplasty. Seven Danish hospitals are currently participating in the study, but additional hospitals can enter the study if adhering to protocol. Ninety-six patients will be included prospectively. Follow-up will be with PROM-questionnaires and clinical controls up to 10 years. The patients who are not able to participate in the randomized trial are followed in a parallel cohort study.
PROM'S: Oxford Knee Score and EQ5D + EQ5D VAS questionnaires are completed preoperatively and sent out to the study participants at 6 weeks, 3, 6, 9, 12, 18 and 24 months as well as 5 and 10 years postoperatively. In addition a tailor made cost questionnaire on the non-treating hospital resource use, community health and social service use, travel costs, time off work and informal care are sent out.
If one of the two treatment alternatives is found superior in both domains of quality of life (both knee-specific and generic) and health economics, that treatment should be promoted. Other outcomes will open informed discussions about treatment strategies for periprosthetic knee infections.
The randomized trial is registered on ClinicalTrials.gov with ID NCT03435679 , initial release date January 31, 2018 and the cohort study is registered with ID NCT04427943 , submitted January 8, 2020 and posted June 11, 2020.
迄今为止，慢性感染性膝关节置换术的金标准一直是两阶段假体置换手术。该手术包括 2 次手术/住院，两次手术之间有 2-3 个月的间隔期，在此期间患者的健康状况、功能状态和生活质量都会受损。与两阶段方法相比，单阶段置换手术具有许多明显的优势，但单阶段与两阶段手术的结果从未在随机临床试验中进行过调查。本研究的主要目的是主要调查单阶段与两阶段翻修后患者功能状态的时间调整差异。其次，报告时间调整后生活质量、并发症（包括因感染而再次翻修）和死亡率的差异。
这是一项实用的、多中心、随机、非劣效性试验，比较了单阶段与两阶段感染性膝关节置换术的翻修。目前有 7 家丹麦医院参与了这项研究，但如果遵守方案，其他医院也可以参与研究。96 名患者将前瞻性纳入。通过 PROM 问卷和临床对照，随访时间长达 10 年。未参与随机试验的患者将在平行队列研究中进行随访。
PROM'S：术前完成牛津膝关节评分和 EQ5D+EQ5D VAS 问卷，并在术后 6 周、3 个月、6 个月、9 个月、12 个月、18 个月和 24 个月以及术后 5 年和 10 年发送给研究参与者。此外，还会发送一份定制的非治疗医院资源使用、社区健康和社会服务使用、旅行费用、休假和非正式护理的成本问卷。
如果两种治疗方案中的一种在生活质量（特定于膝关节和通用）和健康经济学的两个方面都被发现具有优越性，那么就应该推广该治疗方案。其他结果将为探讨治疗假体周围膝关节感染的策略打开知情讨论。
随机试验在 ClinicalTrials.gov 上注册，ID 为 NCT03435679，初始发布日期为 2018 年 1 月 31 日，队列研究在 ClinicalTrials.gov 上注册，ID 为 NCT04427943，提交日期为 2020 年 1 月 8 日，发布日期为 2020 年 6 月 11 日。
