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

NCT04620395 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2020-11-09

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Vivantes Netzwerk für Gesundheit GmbH

    lead OTHER

Principal Investigators

  • Karsten Labs, PD Dr · Vivantes Humboldt Krankenhaus

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-20
Primary Completion
2022-01-31
Completion
2022-06-30
FDA Device
Yes

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04620395 on ClinicalTrials.gov