Clinical trial NCT04620395: Percutaneous Punch Biopsy for Diagnosis of Septic and Aseptic Prosthetic Joint Failure
Official title: Clinical Investigation of Septic and Aseptic Prosthetic Joint Failure - Percutaneous Punch Biopsy as a Novel Way of Diagnosis Confirmation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wear of Articular Bearing Surface of Internal Prosthetic Joint
Infection Prosthetic
Infections Joint Prosthetic
Prosthetic Joint Infection
Prosthetic Pain
Keywords: prosthetic joint
infection
wear particles
prosthetic failure
antibiotics
biopsy
joint tap
Lead sponsor: Vivantes Netzwerk für Gesundheit GmbH
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improved diagnostic accuracy
timeFrame: up to 3 months
Secondary outcomes:
measure: Rate of chronic periprosthetic low-grade-infections
timeFrame: up to 3 Months
measure: Correlation of microbiological results from percutaneous Punch biopsy with intraoperative findings at Revision
timeFrame: up to 6 Months
measure: Total Cost of Infection Diagnostics for various used methods
timeFrame: 1 Month
measure: Rate of prosthetic failure due to wear particles
timeFrame: up to 1 month
measure: Correlation of Synovialitis score and microbiological findings
timeFrame: up to 2 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Vivantes Humboldt-Krankenhaus
Study officials:
affiliation: Vivantes Humboldt Krankenhaus
name: Karsten Labs, PD Dr
role: STUDY_CHAIR
References: