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Periprosthetic Joint Infection clinical trials

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NCT ID: NCT05084378 Active, not recruiting - Clinical trials for Periprosthetic Joint Infection

Evaluation of Emerging New Treatments for Infection Prevention in Total Joint Replacement

PREVENT-IT
Start date: March 11, 2022
Phase: Phase 3
Study type: Interventional

At the end of total joint replacement (TJR) surgery, surgeons wash and clean the surgical wound. This is done to lower the risk of infections. Currently, most surgeons use saline to wash the surgical wound and do not place antibiotics in the wound . However, some recent studies have shown that using povidone-iodine and chlorhexidine-based solutions (both are types of antiseptics) to wash the surgical site and placing antibiotics directly into the wound may be effective in reducing infections in TJR surgery compared to saline and no antibiotics. However, no study has determined which solution is better at reducing the number of infections in patients undergoing TJR. The investigators also do not know if the addition of antibiotics applied to the wound will decrease infections. Currently, there are no surgical guidelines around infection prevention in total joint replacement. A large scale, multi-site, pragmatic 3 x 2 factorial randomized controlled trial is need that compares these six treatment groups. However, before this, a smaller pilot study must be conducted to determine the feasibility of a larger study. PREVENT-iT will address these important gaps in knowledge and clinical practice.

NCT ID: NCT04274517 Terminated - Clinical trials for Periprosthetic Joint Infection

Microbial Growth in Operative Splash Basins During Total Joint Arthroplasty

Start date: January 16, 2021
Phase: N/A
Study type: Interventional

The usage of splash basins in the setting of total knee arthroplasty and total hip arthroplasty presents a risk of contamination and subsequent periprosthetic joint infection. Previous studies have investigated the efficacy of multiple antimicrobial irrigants for preventing periprosthetic joint infection, but the results are varied. Despite several noteworthy studies on the appropriate usage of different antiseptic solutions in surgical splash basins, the current literature has several limitations. First, there are no head-to-head clinical trials comparing betadine and chlorhexidine gluconate (CHG) usage with relation to periprosthetic joint infection and splash basin contamination rates. Second, the in vitro studies directly cultured splash basin antiseptic solutions rather than culturing surgical instruments. The objective of this study is to compare the microbial contamination rate of total joint arthroplasty instruments that have been placed in surgical splash basins filled with either sterile water, 3.5% betadine, or 0.05% CHG. The overall purpose of the study is to investigate the efficacy of 0.05% CHG and determine if it is an appropriate solution to use in surgical splash basins for joint replacement surgeries. A prospective clinical trial will be conducted. Patients treated at the Keck Hospital of USC or USC Verdugo Hills Hospital for primary total hip or total knee arthroplasty will be screened for inclusion in our study. All primary surgeries will be performed according to the preferences of the operating surgeon. No deviations from standard surgical care will be made based on inclusion in this study. However, prior to surgery, patients who elect to participate will be randomized to one of three groups: (1) sterile water, (2) 3.5% betadine, or (3) 0.05% CHG.

NCT ID: NCT03139539 Completed - Clinical trials for Periprosthetic Joint Infection

Intraoperative Microbial Contamination

ICON
Start date: March 2016
Phase: N/A
Study type: Interventional

This is a randomized, controlled study which aims to show whether iodine impregnated incisional foil (IobanTM) has a place in the prevention of prosthetic joint infection (PJI). 1200 patients will be included in this study and will be followed through out a ten year period. Follow up will center on the function of the prosthetic knee, early and late infection rates and revision surgery due to aseptic loosening. Our purpose is to gain insight in to the causes of post-operative infection in joint alloplasty surgery. Our hypothesis' are: 1. The patient's skin flora is the main source of intraoperative contamination, 2. Intraoperative contamination can be reduced by using IobanTM 3. Intraoperative contamination strongly predicts postoperative infection 4. Unsuccessful clinical outcomes of knee arthroplasty are caused by low-grade infections. To our knowledge this is the first study with this large a sample size and as long a follow up. Background PJI is a devastating complication with substantial morbidity and high socio economic costs. Revision surgery due to infection costs as much as six times more than the primary surgery and has a poorer outcome for the patient i.e. disability, pain or loss of function. Methods and materials The study has two main arms: 1. Intraoperative contamination 2. Postoperative infection The first stage aims to document that patients with intraoperative contamination have a larger risk of developing postoperative infection and include a study of the effect of Ioban™. The second stage are to include methods of PCR (polymerase chain reaction) and fluorescence microscopy, to demonstrate bacterial contamination and/or infection of any implants removed during the study period. Perspectives This study will give us new insight in the causes of PJI and the correlation with contamination during surgery. If IobanTM is proved to prevent infection it is a simple way to prevent post-operative infection and can be implemented in any orthopedic department.

NCT ID: NCT02868736 Recruiting - Clinical trials for Periprosthetic Joint Infection

Clinical Validation of CD Diagnostics Synovasure PJI ELISA Test and Synovasure PJI Lateral Flow Test for Detection of Periprosthetic Joint Infection in Synovial Fluid

Start date: July 2016
Phase: N/A
Study type: Observational

- To demonstrate the tests' performance when compared to the detection of PJI using the Musculoskeletal Infection Society (MSIS) criteria-based definition of PJI for diagnosing PJI.1 This criteria-based definition of PJI places emphasis on culture techniques that identify pathogens, but also provides for minor criteria that can be used to diagnose PJI; - To calculate the tests' clinical sensitivity, clinical specificity, positive predictive value (PPV), and negative predictive value (NPV).

NCT ID: NCT02530229 Recruiting - Septic Arthritis Clinical Trials

Arthrocentesis Study

Start date: November 2014
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to analyze pre- and intra-operative joint aspirates of native joints and joints with suspicion of periprosthetic joint infection (PJI) of the hip, knee and shoulder acquired in clinical routine. Joint aspirates are then analyzed with new diagnostic methods (microcalorimetry, PCR, alpha-defensin, etc.). Diagnostic speed and accuracy of these methods is compared to standard diagnostic methods in clinical routine, such as blood cultures of joint aspirates, cell count/differential, intra-operative tissue culture and histology and sonication.