The number of joint prosthesis surgeries is increasing every year, among which the number of hip and knee replacement surgeries stands out. Total knee arthroplasty (TKA) rates have risen dramatically in recent decades, with Germany ranking among the top countries in terms of TKA prevalence. According to recent health studies on TKAs in Germany, the number of surgeries is expected to rise by 43% to 299 per 100,000 inhabitants by 2050, for a total of 225,957 primary TKAs.

Besides, the annual total number of revision procedures is expected to increase by nearly 90% by 2050, accounting for 47,313 procedures. These figures are primarily related to an increase in TKAs as a result of periprosthetic joint infection.

Developing medical technology helps the work of orthopedic specialists, but they still have difficulties that are complicated to overcome with traditional methods. Diagnosing prosthetic joint infections is one of them.

This was the main problem we wanted to help orthopedic specialists to solve when we started developing our product. After many years of dedicated professional work we proudly announce that we have found a proven effective solution: the Lyfestone^Ⓡ Calprotectin test is an innovative high-precision tool that significantly speeds up the identification of prosthetic joint infection.

This article will introduce the Lyfstone^Ⓡ orthopedic test and provide insight into the followings:

• What are the most important milestones in the development of Lyfstone^Ⓡ?
• What is Lyfstone’s^Ⓡ innovative method for diagnosing periprosthetic joint infections?
• What are its advantages compared to conventional tests?
• Recent studies prove its efficacy and reliability.

The Lyfstone^Ⓡ story

The possibility of replacing injured or worn-out joints with prosthetic joints and thereby eliminating the patients’ pain as well as restoring their quality of life is the pinnacle of today’s medicine. The increasing number of prosthetic joints highlighted one of the biggest challenges of the process: how orthopedic surgeons can diagnose quickly and with great certainty whether their patient’s prosthetic joint is infected or not. In other words, to make the right decision on whether revision surgery is necessary.

Finding a well-functioning and innovative solution to this difficulty was our main goal when we started developing the Lyfstone^Ⓡ Calprotectin test. We are based in Tromsø, Northern Norway in an environment supplied with modern equipment, and excellent clinical networks. This is where our highly competent experts spent 5 years developing and validating Lyfstone^Ⓡ, the unique and easy-to-use diagnostic test that is able to rule out infections in prosthetic joints in just 15 minutes. 

Throughout the development process, we had dialogues with orthopedic surgeons across the world to ensure that we were designing the right product for them. In addition, we conducted pivotal trials to demonstrate the medical need and value of employing the test to rule out prosthetic joint infections.

Lyfstone^Ⓡ is now available all over Europe through our distributors for orthopedic surgeons, microbiologists, traumatologists, and infectologists who want accurate and fast results.

What makes Lyfstone^Ⓡ aid unique in diagnosing prosthetic joint infection?

The ability to diagnose prosthetic joint infection quickly and precisely is critical in making the right decision about the need for surgical intervention. This not only helps the patient to have a better prognosis but offers significant medical and economic benefits for the orthopedic surgeon. 

How does it work?

An infected prosthetic joint should be operated on urgently, so ruling out infection is a top priority. The presence of neutrophils is a characteristic of prosthetic joint infection, and infections cause a large release of calprotectin. The Lyfstone^Ⓡ orthopedic test is a CE-IVD labeled bedside test that measures the amount of calprotectin in the patient’s synovial fluid. Calprotectin levels have been shown to be elevated in both acute and chronic prosthetic joint infections.

Lyfstone^Ⓡ Reader app

The first step in using the Lyfstone^Ⓡ orthopedic test is to take a sample from the patient’s synovial fluid. Because of the generally high viscosity of the joint fluid, the biopsy must be diluted before being placed on the test. This can be easily performed by the buffer tube that is part of the testing kit. The buffer tube also helps in the accurate measurement of the joint fluid sample.

The result of the test can be evaluated after 15 minutes, which is assisted by the Lyfstone^Ⓡ Reader app. The Lyfstone^Ⓡ app works on both iOS and Android devices and can be downloaded from Google Play or App Store. 

To get the result, the user must place the smartphone on top of the test and line the screen layout with the support frame. Calprotectin concentration of the synovial fluid and risk stratification group will be presented on the screen. There are 3 possible results:

• Green: low risk of infection 
• Yellow: moderate risk of infection 
• Red: high risk of infection 

How can Lyfstone^Ⓡ help orthopedic surgeons?

The Lyfstone^Ⓡ test is recommended to orthopedic surgeons, infectologist, traumatologists, and clinics who want immediate results. With the help of the Lyfstone orthopedic test, they can make a fast and accurate diagnosis instead of waiting hours to get the results from external laboratories. The simple sample set-up enables its usage at any point of care, from consultation to pre-op and per-op.

Lyfstone^Ⓡ vs. other orthopedic tests 

Our product is a revolutionary innovation in the field of prosthetic joint infection diagnostics. The usage of Lyfstone^Ⓡ has many advantages compared to conventional orthopedic tests that include:

Time-saving

Getting results from laboratories can take hours or even days. The Lyfstone^Ⓡ rapid test is an innovative diagnostic aid that identifies the risk of infection from the synovial fluid after 15 minutes. With the help of this method, the infection can be ruled out quickly, on the spot, in the presence of the patient. This saves lots of valuable time, which is extremely important in the case of prosthetic joint surgeries.

Precise results

Conventional blood cell test results can only show that there is an infection in the body, but not exactly where. For the Lyfstone^Ⓡ Calprotectin orthopedic test, the sample is taken directly from the joint fluid, so the location of the possible infection can be accurately determined from the result. 

Studies and facts about Lyfstone’s^Ⓡ effectiveness

Lyfstone^Ⓡ has been subjected to numerous clinical tests and professional studies and has already proven its effectiveness and reliability: 

• Study on synovial calprotectin’s reliability in diagnosing prosthetic joint infection: Another clinical study was conducted between July 2019 and October 2021 involving thirty-three patients. The study investigated whether calprotectin is reliable for prosthetic joint infection diagnosis in cases with accompanying inflammation due to dislocation, recent surgery, or implant breakage. The result suggests that calprotectin is a reliable diagnostic parameter for the detection of prosthetic joint infection in primary and revision THA and TKA.
• Calprotectin Lateral Flow Test: Between October 2018 and January 2020, 123 patient synovial fluid samples were collected and evaluated utilizing a calprotectin lateral flow POC (point-of-care) assay from revision total knee arthroplasty patients. The results of the study prove that the Calprotectin biomarker has a particularly high sensitivity (98,1%) and specificity (95,7%). Calprotectin surpassed blood-based prosthetic joint infection diagnostic tests including CRP and ESR, proving its diagnostic significance.
• Diagnostic Utility of a Novel POC Test of Calprotectin for prosthetic joint infection After Total Knee Arthroplasty: During this clinical study synovial fluid samples were prospectively collected from 123 patients who underwent revision TKA at 2 different hospitals within the same healthcare system between October 2018 and January 2020. The result of the study confirms that the assessed calprotectin POC test has excellent joint infection diagnostic characteristics, including high sensitivity and specificity. Therefore the test can be effectively implemented as a rule-out test. 

Summary 

With the rising number of joint replacement surgeries, the difficulties for orthopedic specialists in diagnosing prosthetic joint infections also increased. Patients suffering from prosthetic joint infection may suffer from emotional, financial, and physical problems therefore a fast precise diagnosis is critical for determining appropriate treatment options. Most conventional methods, however, are ineffective and/or take a lot of time to rule out whether a prosthetic joint is infected or not. 

Lyfstone^Ⓡ Calprotectin is a highly sensitive bedside test that provides a precise diagnosis of prosthetic joint infections in a very short amount of time. It significantly improves the surgeon’s ability to rule out infections and helps to save considerable amounts of money on healthcare expenses. With the help of Lyfstone^Ⓡ orthopedic test surgeons are able to identify accurately the risk of infection after 15 minutes from the patient’s synovial fluid. According to the research listed in this article, Lyfstone^Ⓡ test’s unique technology can enable physicians to make decisions at the “point-of-care,” which can have a significant influence on healthcare delivery and the potential to quickly address serious health issues like prosthetic joint infection.

Lyfstone^Ⓡ Calprotectin rapid test is available throughout Europe through our professional distributors. Contact your national sales representative and unfold Lystone’s accurate and fast solution for diagnosing prosthetic joint infection.