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Periprosthetic Joint Infection clinical trials

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NCT ID: NCT06268795 Not yet recruiting - Clinical trials for Periprosthetic Joint Infection

A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study)

Start date: February 28, 2024
Phase:
Study type: Observational

The aim of this study is to compare the diagnostic accuracy of percutaneous aspiration against open biopsy, using microbiological and histological methods, for the detection of shoulder and elbow periprosthetic joint infection (PJI). This is to establish the utility of pre-operative joint aspiration in the treatment pathway for shoulder and elbow PJI.

NCT ID: NCT06189885 Not yet recruiting - Clinical trials for Periprosthetic Joint Infection

Preoperative Daptomycin Prophylaxis in Two-Stage Exchange Arthroplasty: A Prospective, Randomized, Double-Blinded Trial

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

The gold standard for treating prosthetic joint infection (PJI) is two-stage exchange arthroplasty. This includes the first stage of debridement and removal of the artificial joint, and the second stage of reimplantation of the artificial joint. Methicillin-resistant staphylococcus aureus (MRSA) infection is one of the factors leading to the failure of artificial joint infection treatment. Before the second stage of the joint surgery, the surgeon will prescribe prophylactic antibiotics based on previous bacterial cultures. The usual preoperative antibiotic is a first-generation cephalosporin antibiotic. If it is MRSA, vancomycin will be given. Increasingly, literature reports link prosthetic joint infections to MRSA, but no changes have been made to the routine recommendation for MRSA prophylactic antibiotic use. Daptomycin is a cyclic lipopeptide antibiotic that can rapidly penetrate biofilms and bones, and its safety and tolerability have been confirmed. Therefore, it can effectively combat Gram-positive organisms, including MRSA. Daptomycin has many characteristics of an ideal prophylactic: short infusion time, low adverse events during administration, and a range limited to Gram-positive organisms. We aim to assess whether adding antibiotics that cover MRSA would reduce prosthetic joint infections and increase surgical success rates, in addition to the standard recommended prophylactic antibiotics. Thus, this prospective randomized trial is designed to assess, besides using the first-generation cephalosporin antibiotic, the effects of adding an antibiotic with MRSA coverage (Daptomycin vs. Vancomycin).

NCT ID: NCT06126614 Not yet recruiting - Clinical trials for Periprosthetic Joint Infection

Infection Prophylaxis in Total Joint Replacement

PREVENT-iT
Start date: November 2023
Phase: Phase 3
Study type: Interventional

Osteoarthritis (OA) is the most common cause of disability in older adults worldwide affecting 7% of the global population, or more than 500 million people globally. Total joint replacements (TJR) can help bring relief to those with osteoarthritis when other treatment options are no longer helpful. Infection is the main reason hip and knee replacements "fail". Failure leads to repeat surgeries that are often more complicated and less likely to be successful than the first surgery. Reducing the risk of infection is extremely important, antiseptic washes and antibiotics may help us do that. After joint replacement surgery, orthopaedic surgeons wash and clean the surgical wound to lower the risk of infection. The goal of this clinical trial is to determine if the use of antiseptic solutions to wash the surgical site and placing an antibiotic directly into the wound will reduce the number of infections requiring reoperation. Patients having total joint replacements will be randomized (like flipping a coin) to receive 6 possible combinations of washes and / or antibiotics. Participants will be followed for one year after TJR to compare the rate of infection in each group.

NCT ID: NCT05640336 Enrolling by invitation - Clinical trials for Periprosthetic Joint Infection

Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression

Start date: March 3, 2023
Phase: N/A
Study type: Interventional

The purpose of this research is to evaluate two different standard of care surgeries in treating periprosthetic joint infection (PJI) after total hip and knee arthroplasty. Researchers are looking at differences in outcomes following single versus planned double debridement, antibiotics, and implant retention (DAIR) for acutely infected total hip arthroplasty (THA), and total knee arthroplasties (TKAs).

NCT ID: NCT05495815 Recruiting - Clinical trials for Periprosthetic Joint Infection

Proper Duration of Suppressive Antibiotic Therapy After Debridement, Antibiotics, and Implant Retention

ProperSAT
Start date: April 2024
Phase: N/A
Study type: Interventional

Multiple studies have demonstrated oral suppressive antibiotic therapy (SAT), after intravenous antibiotics, maximizes reoperation-free survival of total joint arthroplasty (TJA) debridement, antibiotics, and implant retention (DAIR) for acute periprosthetic joint infection (PJI). However, little is known regarding sequelae of SAT after DAIR for PJI. Prior studies have small or heterogeneous patient cohorts, variable antibiotic regimens, arrive at disparate conclusions, and do not establish antibiotic resistance risk. The investigators propose a prospective randomized controlled multicenter study to expand on findings in a retrospective, multi-center pilot study. Study aims are to evaluate SAT after DAIR of acutely infected primary TJA regarding: 1) adverse drug reactions/intolerance; 2) reoperation for infection; and 3) antibiotic resistance.

NCT ID: NCT05357287 Recruiting - Wound Heal Clinical Trials

Closed Incisional Negative Pressure Wound Therapy in Post-surgical Wound Care of Patients With Periprosthetic Joint Infection

Start date: March 15, 2022
Phase: N/A
Study type: Interventional

In the proposed study, we will apply Prevena on the surgical wound right after closure of the wound in the operating theater. Prevena will be used for 7 days, unless there is ongoing infection or much wound drainage that requires debridement. Most periprosthetic joint infections are from hematogenous origin. Hence, it is considered clean wound unless there is a discharging sinus.

NCT ID: NCT05320354 Enrolling by invitation - Clinical trials for Periprosthetic Joint Infection

Diagnosis and Bacterial Identification of Periprosthetic Joint Infection With Microbial-ID

MID
Start date: April 25, 2022
Phase:
Study type: Observational

The primary objective of this study is to demonstrate the validity of the Microbial- ID test to aid in diagnosis of periprosthetic joint infection (PJI) in terms of sensitivity and specificity.

NCT ID: NCT05284318 Recruiting - Clinical trials for Anti-Bacterial Agents

Prospective Cohort Study on Antibiotic Course and Efficacy After Two-stage Revision in PJI.

PACER-PJI
Start date: December 1, 2021
Phase:
Study type: Observational [Patient Registry]

This is a multicenter prospective cohort study in which patients were evaluated by inclusion and exclusion criteria before phase II revision surgery. Eligible patients will be included in this study after signing the informed consent form. After the second stage revision, according to the patient's symptoms and examination results, the attending physician used a reasonable antibiotic treatment scheme (including intravenous and oral medication). All patients voluntarily participated in the study and signed informed consent. During the treatment period, all prospective patients underwent clinical evaluation at the time points of 1, 3, 6, 12, 18 and 24 months after the start of antibiotic treatment after phase II revision. The infection control rate of patients was evaluated by follow-up at least 2 years after operation, so as to analyze the effect of antibiotic treatment course after two-stage revision of periprosthetic joint infection.

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.