Septic Arthritis

This research aims to compare how well two diagnostic methodspercutaneous aspiration and open biopsydetect infections in shoulder and elbow joint replacements that need revision surgery. Periprosthetic joint infection PJI is a serious problem leading to many revision surgeries, and early, accurate diagnosis is crucial but challenging. The study focuses on improving diagnosis methods specifically for shoulder and elbow PJI, as current evidence mainly comes from hip and knee replacements. The study observes patients undergoing revision surgery after shoulder or elbow arthroplasty. It compares the accuracy of pre-operative joint aspiration, which collects fluid samples, against open biopsy, which obtains tissue samples during surgery. Both microbiological and histological tests will be used to assess infection presence. The study follows participants for up to 36 months to evaluate the diagnostic accuracy of these methods. Participants will undergo standard clinical assessments, including laboratory tests of blood and joint fluid, microbiological cultures, tissue analysis, and imaging. Researchers will track infection detection and compare results from aspiration and biopsy samples. The main outcome is the diagnostic accuracy over 36 months, with additional culture analysis completed within 14 days. The study does not involve experimental treatments but focuses on improving infection detection before surgery.

Researchers are studying participants with early or acute hematogenous periprosthetic joint infection PJI following total knee arthroplasty TKA or other joint replacement surgeries. The study aims to evaluate the safety, tolerability, and pharmacokinetics PK of TNP-2092 given by intra-articular IA injection alongside vancomycin intravenous IV and oral antibiotics. This Phase 12, randomized, controlled, open-label study explores treatment options for PJI patients requiring or not requiring debridement, antibiotics, and implant retention DAIR therapy or long-term antibiotic suppression. Participants are assigned to one of four groups a sentinel group receiving TNP-2092 IA plus vancomycin IV and oral antibiotics, an experimental group receiving the same, a control group receiving vancomycin IA plus vancomycin IV and oral antibiotics, or an expansion group receiving TNP-2092 IA based on background treatment. TNP-2092 is administered at 50 mg via IA injection once daily for 14 days, with dose adjustments allowed based on drug concentrations and safety. Oral antibiotic treatment lasts 8 weeks, and vancomycin IV and IA are given daily for 14 days. Participants undergo screening assessments within 7 days before starting the study and must agree to hospitalization for 2 weeks of IA injections. Researchers will monitor safety by tracking adverse events through Day 187 and measure TNP-2092 concentrations in synovial fluid and plasma at multiple time points. They will also assess treatment responses at Day 14 and study end, along with treatment failure within 6 months. The study involves regular blood tests and clinical evaluations to evaluate the treatments pharmacokinetics and local and systemic effects.

Researchers are studying the experiences of people who develop rheumatic immune-related adverse events irAEs after receiving immune checkpoint inhibitor immunotherapy. This study aims to understand how severe these events are, how they affect daily function, and the attitudes of patients towards different aspects of these side effects. The research focuses on conditions like arthritis and polymyalgia rheumatica that arise following this cancer treatment. This observational study does not involve any drug or treatment interventions. Instead, it gathers information through qualitative assessments from patients diagnosed by rheumatologists with inflammatory arthritis or polymyalgia rheumatica as irAEs after immune checkpoint inhibitor therapy. The study is sponsored by M.D. Anderson Cancer Center and will collect data over about one year. Participants will engage in interviews to share their experiences, which will help researchers evaluate the safety and adverse events associated with these immune-related conditions. The study includes monitoring adverse events throughout the study period. The total involvement duration averages one year, allowing for comprehensive understanding of the impact and progression of these rheumatic irAEs.

Researchers are evaluating the long-term outcomes of the ACE Acetabular Cup System, a device used in total hip replacement surgery. This procedure replaces both the hip ball and socket to relieve pain and help patients return to normal activities. The study aims to monitor the safety and performance of this CE-marked device over 10 years by assessing clinical, functional, and radiological results in patients with hip disease. The ACE Acetabular Cup System offers three options for socket liners ceramic, polymer, or dual mobility, allowing surgeons to choose the best fit for each patient. Participants in the study have received a primary elective total hip replacement using this system combined with a JRI femoral stem and head. The study is observational and follows patients over a decade to gather data on device function and patient health. Participants will be followed through questionnaires, reviews of X-rays, and monitoring of any complications. Key measurements include the Oxford Hip Score at 3 years post-operation, along with implant survivorship and other hip function assessments at multiple time points up to 10 years. Radiological assessments will also be conducted at 1, 5, and 10 years. This comprehensive follow-up helps researchers understand how well the device performs long-term and supports patient safety.

Researchers are conducting a study called Acutelines, a large data and biobank project at the University Medical Center Groningen in the Netherlands. It focuses on patients with a wide range of acute medical conditions who present to the Emergency Department. The goal is to improve how acute diseases are recognized and treated, understand their outcomes, and support personalized medicine by collecting detailed clinical data, imaging, and biomaterials over time. Participants have their medical information, including demographics, health status, medical history, vital signs, diagnostic tests, and treatments, systematically collected. Biomaterials such as blood, urine, feces, and hair are gathered from patients who meet certain severity criteria. Data collection occurs during hospital admission, including continuous monitoring, and continues with follow-ups at 3 months, 1 year, 2 years, and 5 years after the initial emergency visit. Throughout the study, various assessments are performed, such as quality of life, physical functioning, mental health, symptoms, and hospital length of stay. Researchers collect data on mortality and other health outcomes for up to 50 years. The study uses digital tools to automate data capture and integrates information from multiple healthcare sources. Participants will be monitored closely during hospitalization and at scheduled intervals afterward to help improve understanding and treatment of acute diseases.

Sepsis is a serious condition caused by the bodys uncontrolled response to infection, which can lead to septic shock, a life-threatening state. This research evaluates whether adding fludrocortisone to the standard treatment with hydrocortisone might improve outcomes for critically ill patients in shock. The study is a Phase II pilot trial designed to test the feasibility of a larger international study that would confirm if this combination therapy can reduce mortality in septic shock. The trial is a randomized, double-blind, placebo-controlled study conducted in six intensive care units across Hong Kong, Australia, and Singapore. Participants will receive either 100 mcg of enteral fludrocortisone daily or a placebo for up to seven days, alongside standard intravenous hydrocortisone given every six hours. The treatment period lasts until discharge from the ICU or death, whichever occurs first. Participants will be critically ill adults who have septic shock and require mechanical ventilation. Researchers will monitor protocol adherence, recruitment rates, time to shock resolution, mortality at 28 days, days free of organ support, and severe electrolyte imbalances. The study includes detailed tracking of feasibility outcomes, data completeness, and safety over approximately 20 months, with the aim of informing a larger future trial.

Differentiating septic arthritis from other causes of joint inflammation in children is critical because septic arthritis requires prompt surgical treatment to prevent lasting joint damage. This study aims to evaluate the accuracy of several synovial fluid biomarkers, including alpha-defensin and others, in diagnosing pediatric septic arthritis. The research focuses on improving rapid diagnosis since current culture methods take several days, causing delays in treatment decisions. Participants include children under 18 years old undergoing joint fluid sampling due to suspected infection or inflammation, as well as normative controls undergoing unrelated procedures without infection. Various synovial fluid tests will be performed, such as alpha-defensin assay, leukocyte esterase test, neutrophil elastase, synovial C-reactive protein, and culture tests. Blood tests and PCR for Kingella kingae in children under 8 will also be conducted. These tests will be compared to joint fluid culture, the current gold standard. Participants take part in one study visit during which joint aspiration or arthroscopy is performed as part of their usual care. Researchers will analyze the synovial fluid and blood samples for these biomarkers and compare results to culture outcomes. The primary outcome is the sensitivity and specificity of these experimental tests for diagnosing infection. Data from this single visit will help determine if these tests can improve early detection of pediatric septic arthritis.

Researchers are evaluating the functional outcomes of two types of shoulder replacement surgeriesanatomic total shoulder arthroplasty TSA and reverse total shoulder arthroplasty RTSAfor patients with primary glenohumeral osteoarthritis who have intact rotator cuffs and no significant glenoid retroversion. The study aims to determine if RTSA provides at least as good results as anatomic TSA and also to explore whether RTSA might lead to better clinical and radiographic outcomes with fewer complications. Participants will be randomly assigned to receive either an anatomic TSA or an RTSA through a deltopectoral surgical approach. Both procedures involve implanting a prosthesis designed to treat primary glenohumeral arthritis. The study compares these two surgical options over a follow-up period of two years. During the study, patients will be assessed using several measures including the American Shoulder and Elbow Surgeons ASES score, Subjective Shoulder Value SSV, range of motion, pain on a visual analog scale, Constant score, and Short Form-12 SF-12. Radiographic evaluations and complication rates will also be recorded over the two-year postoperative period. The total participation duration includes baseline assessment and follow-up evaluations spanning up to two years after surgery.

Shock is a serious condition that can cause multiple organs to fail and can be life-threatening. This research focuses on patients with distributive shock who have low blood pressure despite receiving common vasopressor drugs like noradrenaline and vasopressin. The study evaluates the relationship between renin levels, an enzyme involved in blood pressure regulation, and the use of synthetic angiotensin II, a drug given when standard vasopressors are not enough. Researchers aim to understand which patients might benefit most from angiotensin II treatment based on renin concentration changes. Participants who are adults with distributive shock not responding adequately to noradrenaline and vasopressin will receive an infusion of angiotensin II starting at 20 ngkgmin, adjustable up to 40 ngkgmin as needed. Blood samples will be taken before the infusion and six hours afterwards to measure renin levels. This observational study will track how renin changes during treatment and how it relates to clinical outcomes. During the study, researchers will monitor the number of days patients remain free from organ failure and days spent outside the intensive care unit over 30 days. They will also assess the duration of vasopressor need, the requirement for mechanical ventilation or dialysis, and trends in renin levels within the first six hours. The study participation will last up to 30 days, with close observation of patient responses to angiotensin II and their overall clinical progress.

Researchers are evaluating whether antibiotic impregnated bone graft AIBG can reduce the risk of infection after total hip replacement THR, a common surgery to restore quality of life. Periprosthetic joint infection PJI is a serious complication affecting a small percentage of patients after primary or revision THR. Because the number of these surgeries is expected to rise, new methods to prevent infections, especially in complex cases where antibiotic-loaded bone cement is insufficient, are urgently needed. The study compares two groups of patients undergoing elective THR with bone grafts one group receives a combination of vancomycin and tobramycin antibiotics mixed with allograft bone, while the other group receives a placebo bone graft treated with saline. The treatment is applied locally during revision surgery. This randomized, double-blind trial aims to determine if the antibiotic-treated graft reduces infections requiring reoperation within two years after surgery. Participants will be monitored for at least two years after their hip replacement. Researchers will track the time to reoperation due to infection with bacteria sensitive to the antibiotics used, as well as other infection-related measures. The study involves clinical follow-up to assess infections and implant revisions, with safety and effectiveness monitored throughout the trial period, which continues until 2031.