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

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

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.

Study Overview

• Status: Unknown
• Conditions: Prosthetic Joint Infection; Infections Joint Prosthetic; Wear of Articular Bearing Surface of Internal Prosthetic Joint; Infection Prosthetic; Prosthetic Pain
• Intervention / Treatment: Diagnostic test: Punch biopsy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13509
    • Recruiting
    • Vivantes Humboldt-Krankenhaus
    • Contact: Rafal J Borucki, MD; Phone Number: +4915129211687; Email: rafal.borucki@vivantes.de
    • Contact: Karsten Labs, PD Dr. med.; Phone Number: +4930130121655; Email: karsten.labs@vivantes.de
    • Principal Investigator: Rafal J Borucki, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Joint tap; Joint tap and aspiration of synovial fluid
Experimental: Punch biopsy; Punch biopsy of a prosthetic joint and extraction of 5-7 biopsies from the synovial membrane	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of chronic periprosthetic low-grade-infections	The incidence of hidden chronic periprosthetic infections	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)	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	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	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	up to 2 months

Collaborators and Investigators

• Sponsor: Vivantes Netzwerk für Gesundheit GmbH
• Investigators: Study Chair: Karsten Labs, PD Dr, Vivantes Humboldt Krankenhaus

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2020
• Primary Completion (Anticipated): January 31, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: infection; antibiotics; biopsy; wear particles; prosthetic joint; prosthetic failure; joint tap
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: STUD.20-062; DRKS00022931 (Registry Identifier: DRKS); U1111-1257-2609 (Registry Identifier: Universal Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes