NCT04620395: SHARP

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

Status unknown NA Last updated 9 November 2020

What this trial tests

NA trial testing Punch biopsy in Wear of Articular Bearing Surface of Internal Prosthetic Joint in 132 participants. Status unknown.

Timeline

20 August 2020

Primary endpoint
31 January 2022

30 June 2022

Quick facts

Lead sponsor	Vivantes Netzwerk für Gesundheit GmbH
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	diagnostic
Enrollment	132
Start date	20 August 2020
Primary completion	31 January 2022
Estimated completion	30 June 2022
Sites	1 location across Germany

Drugs / interventions tested

• Punch biopsy

Conditions studied

• Wear of Articular Bearing Surface of Internal Prosthetic Joint — all drugs for Wear of Articular Bearing Surface of Internal Prosthetic Joint →
• Infection Prosthetic — all drugs for Infection Prosthetic →
• Infections Joint Prosthetic — all drugs for Infections Joint Prosthetic →
• Prosthetic Joint Infection — all drugs for Prosthetic Joint Infection →

Sponsor

Vivantes Netzwerk für Gesundheit GmbH

Who can join

18 and older, any sex, with Wear of Articular Bearing Surface of Internal Prosthetic Joint or Infection Prosthetic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.