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

NCT04620395 | Unknown DMC FDA Device

• 3 other identifiers: STUD.20-062DRKS00022931U1111-1257-2609
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Rate of chronic periprosthetic low-grade-infections

  up to 3 Months

• Correlation of microbiological results from percutaneous Punch biopsy with intraoperative findings at Revision

  up to 6 Months

• Total Cost of Infection Diagnostics for various used methods

  1 Month

• Rate of prosthetic failure due to wear particles

  up to 1 month

• Correlation of Synovialitis score and microbiological findings

  up to 2 months

Study Arms (2)

Joint tap

NO INTERVENTION

Joint tap and aspiration of synovial fluid

Punch biopsy

EXPERIMENTAL

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

Diagnostic Test: Punch biopsy

Interventions

Punch biopsy DIAGNOSTIC_TEST

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)

Punch biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Confirmed periprosthetic infection
• Proven allergy to fast-acting local anesthetics

Sponsors & Collaborators

• Vivantes Netzwerk für Gesundheit GmbH: lead

Study Sites (1)

Vivantes Humboldt-Krankenhaus

Berlin, 13509, Germany

RECRUITING

MeSH Terms

Conditions

Infections

Study Officials

• Karsten Labs, PD Dr

  Vivantes Humboldt Krankenhaus

  STUDY CHAIR

Central Study Contacts

Rafal J Borucki, MD

CONTACT

+4915129211687; rafal.borucki@vivantes.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: November 9, 2020
• Study Start: August 20, 2020
• Primary Completion: January 31, 2022
• Study Completion: June 30, 2022
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)