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

Vivantes Netzwerk für Gesundheit GmbH

Status: Unknown

Conditions: Prosthetic Joint Infection; Infections Joint Prosthetic; Prosthetic Pain; Wear of Articular Bearing Surface of Internal Prosthetic Joint; Infection Prosthetic

Treatments: Diagnostic Test: Punch biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04620395

U1111-1257-2609 (Registry Identifier)

STUD.20-062

DRKS00022931 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Joint tap

No Intervention group

Description:

Joint tap and aspiration of synovial fluid

Punch biopsy

Experimental group

Description:

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

Treatment:

Diagnostic Test: Punch biopsy