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Prosthetic Joint Infection clinical trials

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NCT ID: NCT03848091 Completed - Clinical trials for Antibiotic Resistant Infection

Prosthesis Infection and One-step Exchange: Pretreatment by Targeted Antibiotic Therapy in At-risk Patients

Start date: April 1, 2016
Phase:
Study type: Observational

One-step exchange arthroplasty is more and more used in the treatment of chronic infections, especially in patients at risk anesthetic. This strategy is not recommended in patients infected with multidrug-resistant organisms or difficult to treat because of a risk of bacterial persistence on the new implant. Antibiotic pretreatment by a narrow-spectrum molecule and for which resistance acquisition is difficult might be of interest to try to reduce the inoculum and avoid contamination of the new implant.

NCT ID: NCT03826108 Recruiting - Clinical trials for Arthroplasty Complications

ARTHR-IS (Arthroplasties' Infections Due to Staphylococcus Aureus)

Start date: April 16, 2019
Phase:
Study type: Observational

The number of arthroplasties is expected to grow in the next few years. Staphylococcus aureus (SA) is a primary cause of prosthetic joint infection (PJI) with serious consequences. This microorganism is frequently associated with treatment failure, hospitalizations and need of prosthesis removal, leading to an important morbidity and an increase in healthcare costs. ARTHR-IS is a retrospective multi-center study which aims to estimate the burden of SA-PJI after a hip or knee arthroplasty and their risk factors. Other objectives are to quantify the costs, the number of hospitalizations and the surgical procedures needed to treat and control the infection and finally the factors influencing therapeutic failure. Through a case-control design, ARTHR-IS will group 20 hospitals across 5 European countries in order to include 150 cases and 450 controls. The results of this study will provide critical information to develop strategies to prevent and treat SA-PJI and reduce treatment failures. Also, the results from ARTH-IS study will help in the design of future clinical trials in prosthesis infections by providing reliable estimates on the incidence of SA-PJI and the subsequent burden on health care services.

NCT ID: NCT03806166 Active, not recruiting - Diabetic Foot Clinical Trials

Short or Long Antibiotic Regimes in Orthopaedics

SOLARIO
Start date: February 21, 2019
Phase: N/A
Study type: Interventional

Research question: If adults with bone or joint infection have local antibiotic therapy, can they do without prolonged treatment with antibiotics by mouth (oral) or injection? Adults with bone or joint infections are usually given long courses of oral antibiotics or into a vein (intravenous) following surgery. It is also safe to give antibiotics directly into the bone or joint at the time of surgery: this is called local antibiotic therapy. This study investigates whether using local antibiotic therapy would allow shorter courses of oral or intravenous antibiotics, in order to limit antibiotic resistance, side effects and cost. This study compares short against long courses of oral or intravenous antibiotics for adults who have been given appropriate local antibiotic therapy to treat bone or joint infection. Patients who can take part will be randomly divided into two groups within 7 days of surgery. One group will stop oral or intravenous antibiotics, while the other group will continue for 4 weeks or more (standard treatment). Adults with bone and joint infections who have already had surgery and local antibiotic therapy will be invited. Patients will not take part if they need intravenous antibiotics for another reason, or if their infection is caused by bacteria resistant to the antibiotic(s) used in their local antibiotic therapy. Main measurement: how many patients' infections return within 12 months after surgery. This will be decided by a group of doctors who do not know what treatment the patient received. Other important measurements: serious adverse events; side-effects; quality of life; cost of treatment. Patients will be asked questions at their usual clinic visits, and will be given a questionnaire at the start of treatment and 1 year later.

NCT ID: NCT03784807 Recruiting - Clinical trials for Prosthetic Joint Infection

New Strategies for Biofilm Related Infections

Diafilm
Start date: November 2, 2018
Phase:
Study type: Observational

This study aims to develop new assays for synovial fluid analysis able to improve diagnosis of prosthetic joint infections. In particular, use of synovial calprotectin as marker of infection, confocal laser scanning microscopy (CLSM) analysis and methods to assess antimicrobial susceptibility will be evaluated in synovial fluids collected from patients with septic and aseptic failure of the prosthetic implant.

NCT ID: NCT03721328 Completed - Clinical trials for Prosthetic Joint Infection

Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation

Start date: October 26, 2018
Phase: Phase 2
Study type: Interventional

Study Type Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial. Primary Study Objective The objective of the study is to determine the safety profile of local antibiotic irrigation for the treatment of PJI. Primary Outcome Measure The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions. Follow-up Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 12 months from initial surgery.

NCT ID: NCT03717090 Completed - Clinical trials for Prosthetic Joint Infection

Rapid Diagnosis of Prosthetic Joint Infection by Matrix-assisted Laser Desorption

Start date: December 1, 2016
Phase:
Study type: Observational

This is a prospective cohort study. All patients presenting for periprosthetic joint infection and requiring debridement only or resection arthroplasty will be eligible. The synovial joint fluid will be sampled before the arthrotomy at the operation room. The purpose of this study will be to evaluate that 1) the concordance of organism identification by the direct identification of MALTI-TOF MS versus routine identification of MALTI-TOF MS and conventional cultures and 2) the timing of preliminary strain identification by the direct identification of MALTI-TOF MS, routine identification of MALTI-TOF MS and conventional cultures in patients with periprosthetic joint infection.

NCT ID: NCT03714165 Recruiting - Clinical trials for Prosthetic Joint Infection

Alpha Defensin and 16S rRNA Gene in Diagnosis of PJI

Start date: January 1, 2019
Phase:
Study type: Observational

Total joint replacement is considered one of the most successful surgical procedures in the field of orthopedics. Despite this achievement, prosthetic joint infections is still considered a severe complication often leading to catastrophic results and requiring repeated and extensive treatment. The incidence of PJI (a prosthetic joint infection) varies depending on the joint involved; the rate of arthroplasties becoming infected is as follows: 1.7% of primary and 3.2%of non-primary hip arthroplasties. The accurate diagnosis of prosthetic joint infection often involves the combination of multiple factors including symptoms, signs, synovial fluid cell count, serum inflammatory markers, and culture. The sensitivity of synovial fluid culture is only 85%, so a negative culture does not rule out infection. However, the specificity of synovial fluid culture is approximately 95%, and positive cultures often imply the presence of prosthetic joint infection. The synovial fluid alpha-defensin test is an immunoassay that was specifically developed to aid in the diagnosis of prosthetic joint infection . The sensitivity and the specificity of the alpha-defensin immunoassay test have been reported to be above 96%. Molecular diagnostic tests using polymerase chain reaction (PCR) are emerging as a tool for the diagnosis of infections and noninfectious conditions. The application of PCR techniques with primers derived from the highly conserved regions of the bacterial 16S rRNA gene has been useful in the detection of bacterial organisms. Use of broad-range 16S rRNA gene PCR as a tool for identification of bacteria is possible because the 16S rRNA gene is present in all bacteria . Aim of the work: .Determine sensitivity and specificity of alpha defensing and 16S rRNA gene in diagnosis of prosthetic joint infection. - Detection of antibiotic sensitivity for different organisms isolated from synovial fluid

NCT ID: NCT03694925 Completed - Clinical trials for Prosthetic Joint Infection

Diagnostic Utility of a Novel Point-of-Care Test of Calprotectin for Revision Total Knee Arthroplasty

Start date: October 29, 2018
Phase:
Study type: Observational

The purpose of this study is to investigate whether there are quantifiable differences in the level of calprotectin in the synovial fluid that allow separation of different modes of joint implant failure (e.g. infected, aseptic loosening). A subset of primary TKA patients (with history of OA) will be included as a baseline.

NCT ID: NCT03612076 Completed - Clinical trials for Prosthetic Joint Infection

Cost Of Failure Following Reimplantation After a 2-Stage Exchange Strategy For Hip Or Knee Prosthetic Joint Infection

Start date: December 1, 2016
Phase:
Study type: Observational

This study concerns patients having had an infection on their prosthesis (hip, knee,..) and for whom a 2-step exchange of prosthesis has been done. A 2-step exchange consists in explantation of the prosthesis and implementation of a spacer at the first stage, and reimplantation of a new prosthesis in a second stage. Patients with late prosthetic joint infection are at risk for superinfection at the time of reimplantation. The aim of this study is to determine the global cost of management of prosthetic joint infection.

NCT ID: NCT03473392 Completed - Clinical trials for Prosthetic Joint Infection

One-stage Exchange Arthroplasty for Chronic Prosthetic Joint Infections

Start date: April 2016
Phase:
Study type: Observational

The results found in the literature do not allow to define objectively the indications respective for a one-step or a two-step exchange of prosthetic joint. Some criteria could help to decide for one-step exchange or two-step exchange: bacteria is/are identified, profile of the bacteria, anesthetic difficulties,.. A puncture could allow to identify the bacteria involved in the prosthetic joint infection (PJI) and an antibiotherapy for a few days can be given to the patient in order to decrease the inoculum. Then, a one-step exchange can be performed. The purpose of this study is to describe the management of patients who had a pre-treatment before a one-step exchange of their prosthetic joint.