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

Not Applicable

• Conditions: Wear of Articular Bearing Surface of Internal Prosthetic Joint; Infection Prosthetic; Infections Joint Prosthetic; Prosthetic Joint Infection; Prosthetic Pain
• Interventions: Diagnostic Test: Punch biopsy

• Registration Number: NCT04620395
• Lead Sponsor: Vivantes Netzwerk für Gesundheit GmbH

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.

Study Timeline

• Study Start: 2020-08-20
• Study First Submitted: 2020-08-25
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-02
• Last Update Submitted: 2020-11-02
• Study First Posted: 2020-11-09
• Last Update Posted: 2020-11-09
• Primary Completion: 2022-01-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Punch biopsy	Punch biopsy	Punch biopsy of a prosthetic joint and extraction of 5-7 biopsies from the synovial membrane

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Vivantes Humboldt-Krankenhaus; 🇩🇪 Berlin, Germany