Clinical Investigation of Septic and Aseptic Prosthetic Joint Failure - Percutaneous Punch Biopsy as a Novel Way of Diagnosis Confirmation
试验速览
- 阶段
- 不适用
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Improved diagnostic accuracy
研究概览
简要总结
The aim of the superiority study is to establish a reproducible, minimally invasive, cost-effective way of sample collection for microbiological and pathomorphological processing in a clinical setting with avoidance of anesthesia, multiple punctures, as well as potential deep contamination during irrigation.
详细描述
The main aim of the study is to demonstrate the superiority of a punch biopsy over a joint tap to rule out or prove septic prosthesis failure and thus establish a new diagnostic method. The subsequently calculated sensitivities of the previous and the procedure are used as the main indicator. In addition, we would like to prove that the total cost of diagnosing a septic / aseptic prosthesis failure using the proposed method has socio-economic advantages over the previous algorithm.
One of the secondary objectives is the evaluation of the use of a punch biopsy for simultaneous a priori pathomorphological examination of periprosthetic soft tissue samples for the determination of wear particles. Furthermore, the study is intended to demonstrate a shortening of the time span between the first suspected diagnosis of septic prosthesis failure and its reliable exclusion / detection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- •Preceding implantation of a shoulder, hip or knee endoprosthesis
- •Acute or chronic pain in the joint
- •Periprosthetic fracture
- •Instability of the endoprosthesis
- •Indications of wear / insufficiency of the enclosed plastic spacers
- •Indications of metal abrasion
- •Primary misalignment of the implant
排除标准
- •Confirmed periprosthetic infection
- •Proven allergy to fast-acting local anesthetics
结局指标
主要结局
Improved diagnostic accuracy
时间窗: up to 3 months
Comparison of the specificity and sensibility of microbiological results for punch biopsies, the synovial fluid tap, pre-interventional blood Analysis, arthroscopic biopsies for confirmation/exclusion of a bacterial or fungal periprosthetic infection
次要结局
- Rate of chronic periprosthetic low-grade-infections(up to 3 Months)
- Correlation of microbiological results from percutaneous Punch biopsy with intraoperative findings at Revision(up to 6 Months)
- Total Cost of Infection Diagnostics for various used methods(1 Month)
- Rate of prosthetic failure due to wear particles(up to 1 month)
- Correlation of Synovialitis score and microbiological findings(up to 2 months)