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Prosthetic Joint Infection clinical trials

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NCT ID: NCT04946500 Active, not recruiting - Clinical trials for Prosthetic Joint Infection

Clindamycin in Prosthetic Joint Infections Caused by Staphylococcus (CISTA)

CISTA
Start date: May 15, 2021
Phase:
Study type: Observational

The alternatives to the combination of Fluoroquinolone and Rifampicin in prosthetic joint infections (PJI) caused by staphylococcus are currently unclear. Clindamycin is prescribed as dual therapy in this indication, and provides many advantages. We conducted a multicenter retrospective observational study evaluating the efficacy and safety of Clindamycin in prosthetic joint infections due to staphylococcus between January 2013 and December 2019.

NCT ID: NCT04938193 Recruiting - Clinical trials for Prosthetic Joint Infection

68Ga-citrate PET/CT for the Diagnosis of Chronic Prosthetic Hip or Knee Infection

Gal-I-TEP
Start date: February 2, 2022
Phase: Phase 2
Study type: Interventional

Diagnosis of chronic prosthetic joint infection (PJI) can be difficult. 68Ga-citrate Positron Emission Tomography/Computed Tomography (PET/CT) has been recently developed and has many advantages such as high resolution and low radiation exposure. To date, 68Ga-citrate PET/CT has not been specifically assessed in prosthetic joint infection. In this prospective study, patients referred for a suspected PJI will benefit from both a 68Ga-citrate PET/CT and a 99mTc-HMPAO-labelled leukocyte SPECT/CT. The primary outcome is the assessment of the 68Ga-citrate PET/CT accuracy for the diagnosis of chronic prosthetic hip or knee infection.

NCT ID: NCT04858217 Recruiting - Clinical trials for Prosthetic Joint Infection

Periprosthetic Joint Infections: Diagnostic Accuracy and Cost-effectiveness Analysis of Serum and Synovial Markers

DECISION
Start date: February 1, 2022
Phase:
Study type: Observational

Total joint replacement (TJR) is an increasing effective procedure in orthopedics. However, TJR failure due to aseptic or septic loosening remains an important problem, often due to predisposing factors of the patient, which determine the need to perform a revision surgery. In light of the recent conclusions emerged on the still open problems concerning the diagnostic accuracy of serum and synovial fluid markers in the diagnosis of peri-prosthetic joint infection (PJI), the project aims at evaluating the diagnostic accuracy and cost-effectiveness of the combination of serum and/or synovial markers in the diagnosis of PJI. Through a diagnostic clinical study on patients hospitalized for revision surgery the project would provide evidences on the potentiality of the combination of some markers in accelerating the PJI diagnosis for the best selection of surgical strategy, choosing the suitable cutoff thresholds to mitigate the effect of some factors on markers' discriminatory capability.

NCT ID: NCT04787250 Withdrawn - Clinical trials for Prosthetic Joint Infection

Bacteriophage Therapy in Patients With Prosthetic Joint Infections

Start date: October 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.

NCT ID: NCT04763759 Completed - Clinical trials for Prosthetic Joint Infection

Study to Evaluate Safety and Activity of TRL1068 in Prosthetic Joint Infections

Start date: February 8, 2021
Phase: Phase 1
Study type: Interventional

TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making these pathogens substantially more susceptible to established antibiotic treatment regimens. This initial study is designed to assess overall safety and pharmacokinetics (PK) of TRL1068. The overall goal of the development program is to demonstrate that TRL1068 can facilitate effectiveness of a single stage joint replacement or preservation of the original infected prosthetic joint in a substantial proportion of patients with PJI.

NCT ID: NCT04762706 Recruiting - Clinical trials for Prosthetic Joint Infection

Measuring Distress in Prosthetic Joint Infection Using a Standardized Metric: CRUTCH Pathway Pilot.

Start date: March 4, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether patients being treated for prosthetic joint infections (PJI) experience distress during the course of their treatment and how distress influences various aspects of their lives. WVU expects to enroll approximately 12 subjects. Patients identified as scoring ≥4 on the Distress Thermometer at the two-week follow-up visit will be offered the opportunity to participate in the novel CRUTCH Pathway. Once enrolled, you will meet virtually with a mental health provider. The mental health provider will complete a 30-minute intake visit where he will review your distress thermometer scoring, discuss contributing factors to current distress level, and assess for psychiatric comorbidities.

NCT ID: NCT04746001 Enrolling by invitation - Clinical trials for Prosthetic Joint Infection

Artificial Intelligence in the Diagnosis of Orthopaedic Conditions, Particularly Bone Tumours and Infection

AIortho
Start date: June 28, 2021
Phase:
Study type: Observational

Translational research aimed at improving diagnostic accuracy of musculoskeletal infection and musculoskeletal tumours using machine learning applied to clinical data, histopathological sections and genomic sequencing.

NCT ID: NCT04724603 Recruiting - Clinical trials for Prosthetic Joint Infection

Phage Safety Retrospective Cohort Study

PHASACO-retro
Start date: February 1, 2021
Phase:
Study type: Observational

The aim of this study is to determine the imputability of adverse events in patients who have had phage therapy for the treatment of their bone or joint or implant infection, in order to find out whether these adverse effects are related to surgery, antibiotic treatment or bacteriophages.

NCT ID: NCT04662632 Completed - Clinical trials for Prosthetic Joint Infection

Abbreviated Protocol for Two-Stage Exchange

APEX
Start date: November 1, 2021
Phase: Phase 2
Study type: Interventional

Study Type: A multi-site, parallel group, randomized trial. Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days). Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 90 days, consisting of a revision prosthesis implanted at Stage 2, patient survival, absence of reoperation and absence of periprosthetic joint infection (PJI). Secondary objectives are to evaluate superiority at 365 days in a composite endpoint of Overall Success, and in separate secondary endpoints for quality of life and patient survival. The exploratory objective is to compare Experimental and Control Arms in exploratory endpoints. Follow-up: Patients will be evaluated at 90-, 180-, and 365-day follow-up visits.

NCT ID: NCT04661345 Recruiting - Clinical trials for Prosthetic Joint Infection

Identification of Molecular Marker of Coagulase-negative Staphylococci for the Diagnosis of Prosthetic Joint Infections

Start date: October 14, 2020
Phase:
Study type: Observational

One of the major causes of prosthetic joint failure is infection. Recently, coagulase-negative Staphylococci (CoNS) have been identified as emergent, nosocomial pathogens involved in subclinical prosthetic joint infections (PJIs). The diagnosis of PJIs mediated by CoNS is complex and demanding due to the absence of clear clinical signs derived from the host immune system response. In this scenario, the key to successful surgical treatment is the capability to differentiate between aseptic implant loosening and septic failure. Hence, the central hypothesis of this study is that proteomic analysis of the secretome of CoNS clinical isolates associated with the characterization of patient synovial fluids will reveal a panel of putative biomarkers tightly linked to PJIs. The confirmation of the presence of bacterial PJI biomarkers in synovial fluids of infected patients will pave the way for the development of a new reliable test capable of aiding in the diagnosis of subclinical PJIs.