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

NCT ID: NCT04620395

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-20

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Wear of Articular Bearing Surface of Internal Prosthetic Joint Infection Prosthetic Infections Joint Prosthetic Prosthetic Joint Infection Prosthetic Pain

Keywords

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prosthetic joint infection wear particles prosthetic failure antibiotics biopsy joint tap

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Joint tap

Joint tap and aspiration of synovial fluid

Group Type NO_INTERVENTION

No interventions assigned to this group

Punch biopsy

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

Group Type EXPERIMENTAL

Punch biopsy

Intervention Type 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)

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vivantes Netzwerk für Gesundheit GmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karsten Labs, PD Dr

Role: STUDY_CHAIR

Vivantes Humboldt Krankenhaus

Locations

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Vivantes Humboldt-Krankenhaus

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Rafal J Borucki, MD

Role: CONTACT

Phone: +4915129211687

Email: [email protected]

Facility Contacts

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Karsten Labs, PD Dr. med.

Role: primary

Rafal J Borucki, MD

Role: backup

Other Identifiers

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DRKS00022931

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1257-2609

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUD.20-062

Identifier Type: -

Identifier Source: org_study_id