Percutaneous Punch Biopsy for Diagnosis of Septic and Aseptic Prosthetic Joint Failure — SHARP  

Prosthetic Joint Infection Clinical Trial

Official title: Clinical Investigation of Septic and Aseptic Prosthetic Joint Failure - Percutaneous Punch Biopsy as a Novel Way of Diagnosis Confirmation

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infection Prosthetic
• Infections Joint Prosthetic
• Prosthetic Joint Infection
• Prosthetic Pain
• Wear of Articular Bearing Surface of Internal Prosthetic Joint

• NCT number: NCT04620395
• Study type: Interventional
• Source: Vivantes Netzwerk für Gesundheit GmbH
• Contact: Rafal J Borucki, MD
• Phone: +4915129211687
• Email: rafal.borucki@vivantes.de
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2020
• Completion date: June 30, 2022