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

Prosthetic Joint Infection Clinical Trial

— SHARP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04620395
• Other study ID #: STUD.20-062
• Secondary ID: DRKS00022931U111
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2020
• Source: Vivantes Netzwerk für Gesundheit GmbH
• Contact: Rafal J Borucki, MD
• Phone: +4915129211687
• Email: rafal.borucki[@]vivantes.de
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: June 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Diagnostic Test:
• Punch biopsy
A standardized biopsy kit is used for a synovial fluid tap and subsequent acquisition of up to 7 Punch biopsies through an introducer (part of the kit)

Locations

Country	Name	City	State
Germany	Vivantes Humboldt-Krankenhaus	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Vivantes Netzwerk für Gesundheit GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 3 months
Secondary	Rate of chronic periprosthetic low-grade-infections	The incidence of hidden chronic periprosthetic infections	up to 3 Months
Secondary	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)	up to 6 Months
Secondary	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	1 Month
Secondary	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	up to 1 month
Secondary	Correlation of Synovialitis score and microbiological findings	Correlation of Synovialitis score in pathomorphological examinations and microbiological verification of an acute or chronic periprosthetic infection	up to 2 months