Efficacy and Safety of Fast-track Treatment for Prosthetic Joint Infection (PJI)
试验速览
- 阶段
- 不适用
- 入组人数
- 418
- 主要终点
- Infection outcome
研究概览
简要总结
Patients with hip, knee and shoulder PJI, will be treated with a two-stage exchange Revision.
Patients will be randomized into 2 groups: the experimental Group will get a reimplantation after a short interval (2-3 weeks) while the control Group after a long standard interval.
Primary objective of the study is "Infection outcome". The infection-free status is defined as absence of clinical (e.g. no fistula), laboratory (e.g. normal C-reactive protein) and radiological signs of infection (e.g. no septic loosening).
Secondary objective is "Functional outcome".The functional assessment will be performed using joint-specific scores (HARRIS HIP SCORE, CONSTANT SHOULDER SCORE, KNEE SOCIETY SCORE, OXFORD HIP SCORE, OXFORD KNEE SCORE, QUICK DASH SCORE) involving the range of motion (ROM), patient mobility / independency in daily life, subjective evaluation of pain using a visual analog pain scale (1-10 points) and life-quality evaluation (EQ5D5L score).
详细描述
A two-stage prosthesis exchange after a long interval of ≥6 weeks is considered the "gold standard" for management of prosthetic joint infection (PJI). We will compare the efficacy and safety of a novel surgical approach with short interval of 2-3 weeks ("fast-track") compared to the standard long interval of 6-10 weeks. Included will be patients with hip, knee or shoulder PJI, in whom all prosthetic components are removed; excluded will be patients treated with prosthesis retention or one-stage exchange and PJI caused by difficult-to-treat organisms. Patients will be randomized into short versus long interval surgical procedure, using a standard antibiotic regimen of 12 weeks in both study arms. The recruitment period of this multicenter treatment/outcome trial is 24 months, follow-up period 12 months and the calculated sample size 418 patients (i.e. 209 patient for each study arm). Primary endpoint is the infection outcome, secondary endpoint is the functional outcome, defined by established scores for joint-specific scores, pain and quality of life scores. The expected outcomes in the short interval ("fast-track") arm are (i) improved infection outcome (i.e. longer infection-free period and less treatment-related adverse events); (ii) improved functional outcome, and (iii) reduced healthcare expenses. In addition, pharmacokinetic studies will be performed and a biobank of microbes and biological samples will be established. This study has high clinical relevance for an increasing public health challenge related to device-associated infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged ≥18 years with hip, knee or shoulder PJI, in whom all prosthetic components are removed.
- •The standard treatment for systemic and local antibiotics is followed (predetermined algorithm).
- •Subjects are willing to participate in the study (signed informed consent) and comply with planned follow-up assessments (at 3, 6 and 12 months after study inclusion).
排除标准
- •Treatment with debridement and prosthesis retention (e.g. performed in early postoperative or acute hematogenous infections with symptom duration <3 weeks) or one-stage exchange.
- •PJI caused by difficult-to-treat organisms, including rifampin-resistant staphylococci, quinolone-resistant Gram-negative bacilli and fungi.
- •Subject previously enrolled in this study or is currently enrolled in another competitive investigational study.
结局指标
主要结局
Infection outcome
时间窗: 12 months after surgery
Duration of infection-free interval and frequency of adverse events related to surgical treatment. The infection-free status is defined as absence of clinical (e.g. no fistula), laboratory (e.g. normal C-reactive protein) and radiological signs of infection (e.g. no septic loosening).
次要结局
- Functional outcome(12 months after surgery)
研究者
Andrej Trampuz
PD Dr. Andrej Trampuz
Charite University, Berlin, Germany