Clinical Investigation of Septic and Aseptic Prosthetic Joint Failure - Percutaneous Punch Biopsy as a Novel Way of Diagnosis Confirmation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Wear of Articular Bearing Surface of Internal Prosthetic Joint
- Sponsor
- Vivantes Netzwerk für Gesundheit GmbH
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Improved diagnostic accuracy
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Improved diagnostic accuracy
Time Frame: up to 3 months
Comparison of the specificity and sensibility of microbiological results for punch biopsies, the synovial fluid tap, pre-interventional blood Analysis, arthroscopic biopsies for confirmation/exclusion of a bacterial or fungal periprosthetic infection
Secondary Outcomes
- Rate of chronic periprosthetic low-grade-infections(up to 3 Months)
- Correlation of microbiological results from percutaneous Punch biopsy with intraoperative findings at Revision(up to 6 Months)
- Total Cost of Infection Diagnostics for various used methods(1 Month)
- Rate of prosthetic failure due to wear particles(up to 1 month)
- Correlation of Synovialitis score and microbiological findings(up to 2 months)