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

Sponsor

Vivantes Netzwerk für Gesundheit GmbH (Other)

Overall Status

Recruiting

CT.gov ID

NCT04620395

Collaborator

(none)

132

Enrollment

Location

Arms

22.3

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wear of Articular Bearing Surface of Internal Prosthetic Joint Infection Prosthetic Infections Joint Prosthetic Prosthetic Joint Infection Prosthetic Pain	Diagnostic Test: Punch biopsy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

132 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Aug 20, 2020

Anticipated Primary Completion Date :

Jan 31, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Improved diagnostic accuracy [up to 3 months]
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

Secondary Outcome Measures

Rate of chronic periprosthetic low-grade-infections [up to 3 Months]
The incidence of hidden chronic periprosthetic infections
Correlation of microbiological results from percutaneous Punch biopsy with intraoperative findings at Revision [up to 6 Months]
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)
Total Cost of Infection Diagnostics for various used methods [1 Month]
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
Rate of prosthetic failure due to wear particles [up to 1 month]
Incidence of presence of wear particles in pathomorphological examinations of the punch biopsies and the samples taken during the replacement operation
Correlation of Synovialitis score and microbiological findings [up to 2 months]
Correlation of Synovialitis score in pathomorphological examinations and microbiological verification of an acute or chronic periprosthetic infection