An observational study in Prosthetic Joint Infection, Prosthetic Infection and Arthroplasty Complications, sponsored by Technical University of Munich. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2021-09-29.
Sponsored by Technical University of Munich · Observational
A bacterial infection of an artificial joint is a serious complication that often requires additional surgery to exchange the arthroplasty. It is also difficult to recognize an infected joint, as the symptoms caused by the infection are very similar to those of other problems with arthroplasties, such as loosening of the implant. To improve the ability to diagnose prosthetic joint infections, this study compares the levels of calprotectin, a specific inflammatory protein, in the joint fluid of infected joints and joints with other complications. The underlying hypothesis is that the level of calprotectin in infected joints is significantly higher, thus facilitating the diagnosis of prosthetic joint infection.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 500 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with painful or failed arthroplasty of the hip or knee joint scheduled for partial or complete arthroplasty exchange.
Exclusion Criteria:
Patients with septic arthroplasty failure
Diagnostic Test: Calprotectin Lateral Flow Test
Patients with aseptic causes of arthroplasty failure
Diagnostic Test: Calprotectin Lateral Flow Test
Semiquantitative point of care photometric assay for the calprotectin level in joint fluid aspirate
Diagnostic accuracy of synovial fluid calprotectin
The level of synovial fluid calprotectin measured in joint fluid aspirate as a diagnostic test for prosthetic joint infection. The accuracy is calculated by comparing its results with the International Consensus Meeting (ICM) on prosthetic joint infection criteria of 2018.
Time frame: Intraoperatively
Plan to share: No
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Technical University of Munich