Periprosthetic joint infection (PJI) is a devastating and costly complication following total hip replacement and total knee replacement. With the increase in the number of total joint replacements procedures performed annually, the number of complications involving revision surgery are also on the rise. PJI often results in implant failure and places a significant financial burden on both patients and the health care system as well as significant physical and psychological morbidity on the patients.

Diagnosis and management of PJI is challenging as there is no “gold standard” for diagnosis of PJI. Current diagnostic tests for PJI have low specificities and sensitivities and may show false positives in certain conditions unrelated to infection. Therefore, there has been a number of attempts to develop more specific biomarkers for PJI.

To that end, the inventors have demonstrated that serum D-dimer assessment may be useful in the diagnosis of PJI. D-dimer is a fibrin degradation product and the serum levels indicate fibrinolytic activities resulting from infections. Thus, they concluded that patients with PJI may have a high level of circulating D-dimer and that the presence of a high level of serum D-dimer may be a sign of persistent infection in patients awaiting reimplantation.

Potential Application

This technology details the development of a diagnostic test to reliably diagnosis periprosthetic joint infection (PJI).

The serum D-dimer significantly outperformed current PJI diagnostic tests with a sensitivity of 89% and a specificity of 93%.

Opportunity

PJI remains a major cause of implant failure in total hip replacement (THR) and total knee replacement (TKR) and need for revision surgery. The incidence of infection has declined over the years with infection rates after THR and TKR currently standing at around 0.3–0.6 and 1%. respectively. Despite this decline, PJI is still one of the most challenging complications after joint arthroplasty, and it constitutes an economic burden both on patients and on society. In 2010 there were 310,000 THRs in the US and 719,000 TKRs. Based on the incidence of infection, in 2010 there were approximately 1,000 infections in THR and approximately 7,000 infections in TKR. By 2030 these numbers are expected to climb to 572,000 THRs and 3.48 million TKRs. Thus, the market for a reliable diagnostic for PJI is large and growing.

This market would also include the cost savings in fewer revision surgeries, and it has been estimated that even with a 2% decline in U.S. revision rates, a savings of over $65 million in Medicare costs would be realized.

Rowan University is looking for a partner for further development and commercialization of this technology through a license.