Trials / Unknown
UnknownNCT04620395
Percutaneous Punch Biopsy for Diagnosis of Septic and Aseptic Prosthetic Joint Failure
Clinical Investigation of Septic and Aseptic Prosthetic Joint Failure - Percutaneous Punch Biopsy as a Novel Way of Diagnosis Confirmation
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- Sponsor
- Vivantes Netzwerk für Gesundheit GmbH · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Wear of Articular Bearing Surface of Internal Prosthetic Joint
- Infection Prosthetic
- Infections Joint Prosthetic
- Prosthetic Joint Infection
- Prosthetic Pain
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2020-08-20
- Primary completion
- 2022-01-31
- Completion
- 2022-06-30
- First posted
- 2020-11-09
- Last updated
- 2020-11-09
Locations
1 site across 1 country: Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04620395. Inclusion in this directory is not an endorsement.