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

N/AUnknownNCT04620395

Vivantes Netzwerk für Gesundheit GmbH132 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

132

Conditions

Wear of Articular Bearing Surface of Internal Prosthetic Joint

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * Confirmed periprosthetic infection * Proven allergy to fast-acting local anesthetics

Outcomes

Primary Outcomes

Improved diagnostic accuracy

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

Time frame: up to 3 months

Secondary Outcomes

Rate of chronic periprosthetic low-grade-infections

The incidence of hidden chronic periprosthetic infections

Time frame: up to 3 Months

Correlation of microbiological results from percutaneous Punch biopsy with intraoperative findings at Revision

Correlation of pre-revision microbiological findings and the samples taken during the endoprosthesis replacement operation, in particular the sonicate of the prosthesis and the periprosthetic membrane (gold standard for infection diagnostics)

Time frame: up to 6 Months

Total Cost of Infection Diagnostics for various used methods

Comparison of the respective Overall Costs for diagnostics of acute and chronic periprosthetic infections using a joint-tap, the novel punch biopsy method and arthroscopic biopsy

Time frame: 1 Month

Rate of prosthetic failure due to wear particles

Incidence of presence of wear particles in pathomorphological examinations of the punch biopsies and the samples taken during the replacement operation

Time frame: up to 1 month

Correlation of Synovialitis score and microbiological findings

Correlation of Synovialitis score in pathomorphological examinations and microbiological verification of an acute or chronic periprosthetic infection

Time frame: up to 2 months