Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05159739 |
| Other study ID # |
95940 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 7, 2018 |
| Est. completion date |
March 2028 |
Study information
| Verified date |
April 2024 |
| Source |
University of Utah |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The investigators primary objective is to identify genetic factors that may increase the risk
of patients developing a periprosthetic joint infections (PJI) following total joint
arthroplasty (TJA). The investigators hope that by identifying genetic predispositions we
will be able to provide patient specific care pathways to prevent or minimize the risk for
PJI.
Description:
Surgical site infections (SSI), and more specifically periprosthetic joint infections (PJI),
have plagued the orthopaedic surgeon since the introduction of total joint arthroplasty (TJA)
procedures of the hip or knee in the mid twentieth century. It is estimated that the economic
burden of PJI in the United States will approach 1.62 billion USD by 2020. Though methods of
infection control have improved, the rate of PJI appears to have plateaued in the last
several decades. Early rates of PJI in the first two decades of THA have been reported
between 1 - 9%. Since the 1980's studies have reported rates between 1% - 3%. It has been
suggested that as orthopaedic surgeons, doctors should not be satisfied with deep infection
rates greater than 1%. Therefore, more must be done in order to prevent, or diminish the
frequency, of PJI and its devastating effects on this patient population.
In hopes of allowing for early targeted prevention in potentially high-risk patients, risk
calculators have been developed to identify patients at greater risk for developing infection
following TJA. However, some investigators suggest that these scoring systems may not be
ready for primetime use. Thus, further research is needed to improve the ability to
accurately identify individuals at high risk for infection. Unfortunately, the ability to
perform large scale longitudinal cohort studies needed to create and test these risk
calculators isn't feasible. Thus, other methods of early identification are needed.
Genetic susceptibility testing for identifying patients at risk for disease is becoming more
popular and may be a means by which patients at high-risk for PJI can be identified. A recent
dermatological study on genetic risk factors for infection suggest that host attributes may
play a role in the ability of the individual to be infected. When evaluating the risk of
subsequent different site infection in patients with multiple TJA's, investigators suggest
that some patients may be at greater risk for infection due to possible subclinical immune
deficiencies. In 2013, one investigator reported familial susceptibility to surgical site
infections (SSI), including but not isolated to PJI, through a large population based study.
Further, a recent publication from this investigating institution demonstrated familial
clustering in patients who suffered a PJI, showing an increased risk of PJI following TJA in
relatives of patients who have experienced PJI. These families demonstrated infection rates
of 9 - 17%. After performing a systematic review on the genetic susceptibility to PJI, the
investigators concluded that though evidence exists supporting a genetic role in PJI, no
definitive conclusions can be made given the relatively small amount of data available in the
existing literature. The investigators further emphasize the need for prospective studies to
validate previous findings and the relationship between genetic factors and PJI.
Given the evidence in the literature, the investigators hypothesize that a large familial
study will provide greater evidence of a genetic susceptibility. The results of this study
could validate previous research with smaller sample sizes and allow for early identification
of high-risk patients via genetic susceptibility testing.
