[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prosthetic-joint-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prosthetic-joint-infection":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,52,86,110,138,167,189,217,238,261,286,311,332,357,382,412,433,457,478],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100609417","phase-2-evaluation-of-plg0206-in-prevention-of-recurrent-infection-in-patients-undergoing-debridement-antibiotics-and-implant-retention-dair-for-treatment-of-a-periprosthetic-joint-infection-pji-following-knee-arthroplasty-100609417",false,"NCT07214311","Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty","RETAIN: A Phase 2\u002F3 Randomized, Placebo-Controlled Study to Evaluate the Efficacy of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Total Knee Arthroplasty (TKA)","RETAIN","Inclusion Criteria:\n\n* Male or female participants age between 18 and \\\u003C80 years\n* Able to provide informed consent, geographically stable, and able to comply with the required follow-up visits\n* Suspected or confirmed PJI of the knee\n* Well-fixed and positioned prosthesis and good condition of surrounding soft tissue (no sinus tract)\n* A single DAIR procedure is indicated as treatment of PJI\n* Agree to use contraceptives if of childbearing potential\n\nExclusion Criteria:\n\n* Loose prosthesis or surgical treatment planned for removal of well-fixed, nonmodular implants\n* Anticipated to require antibiotic therapy for \\>6 months after DAIR procedure\n* Infection spread beyond the affected knee joint (e.g., osteomyelitis)\n* History of a prior PJI of the affected knee\n* Two or more prior revisions in the affected joint\n* Epithelialized sinus tract with evidence of communication to the joint or visualization of prosthesis\n* Diabetes mellitus and with an A1c ≥9%\n* History of malignant disease and having received immunosuppressive therapy, radiation therapy, or chemotherapy within the past year\n* Known immunodeficiency (e.g., splenectomy; sickle cell anemia; human immunodeficiency virus \\[HIV\\] with recent CD4 count \\\u003C200 cells\u002Fmm3; or primary humoral, bone marrow, or other transplantation)","ALL","18 Years","80 Years",{"count":21,"type":22},240,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","The goal of this clinical trial is to evaluate whether the investigational drug PLG0206 can help reduce recurrence of infection in adults who have undergone total knee replacement and are receiving a DAIR (Debridement, Antibiotics, and Implant Retention) surgical procedure to treat a Prosthetic Joint Infection (PJI). The study will also assess the safety of PLG0206 when used as an irrigation solution during the DAIR procedure.\n\nParticipants will receive either PLG0206 or a placebo (an inactive substance that looks like the investigational drug), in addition to standard of care treatments. All participants will be monitored for approximately one year following their DAIR procedure.",[29],"Prosthetic-joint Infection",[31,32,33,34,35,36,37,38],"PJI","TKA","DAIR","Joint Infection","Knee Replacement","Prosthetic Joint","Arthroplasty","PLG0206","RECRUITING","2026-07-01",{"date":42,"type":43},"2026-07-02","ACTUAL",{"date":45,"type":43},"2026-02-03",{"date":47,"type":22},"2028-09",{"name":49,"class":50},"Peptilogics","INDUSTRY",13,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100601222","prosthetic-joint-infection--lessons-from-deceased-patients-in-critical-care-100601222","NCT07107685","Prosthetic Joint Infection : Lessons From Deceased Patients in Critical Care.","Osteoarticular Sepsis In Intensive Care Units : a Retrospective Study About Deceased Patients.","OASIS²","Inclusion Criteria:\n\n* Patient aged 18 years or older.\n* Hospitalization in critical care (intensive care unit or continuing care unit) between 2018 and 2022, lasting at least 48 hours, with a prosthetic joint infection (hip, knee, or shoulder prosthesis infection) as the primary or associated diagnosis.\n* Deceased patient who had not refused data processing.\n\nExclusion Criteria:\n\n* Infection involving osteosynthesis material\n* Infection involving spinal instrumentation\n* Patient with multiple infected prostheses\n* Recurrence of prosthetic infection with the same microorganism as a previous episode\n* Patient under legal protection\n* Pregnant or breastfeeding patient\n* Patient deprived of liberty",{"count":61,"type":22},150,"OBSERVATIONAL","This is an observational, retrospective, multicenter study based on the use of demographic, clinical and biological data from deceased patients admitted between 2018 and 2022 to critical care with a principal or associated diagnosis of joint prosthesis infection.\n\nData from this study will be combined with that from the OASIS study (APHP241174\u002F ID-RCB: 2024-A01769-38) concerning osteoarticular sepsis on prosthetic material in critical care of living patients.\n\nThe aim of this study is to improve our knowledge of the profile, care trajectories and outcomes of patients hospitalized in critical care in the context of osteoarticular material sepsis.\n\nThe results of the study could help identify at-risk populations and improve management strategies for patients with osteoarticular sepsis.",[65,66,67],"Osteoarticular Infections","Intensive Care Patients","Prosthetic Joint Infection",[69,70,71,72,73,74],"Osteoarticular sepsis","sepsis","osteoarticular prothetis","intensive care","critical care","prosthetic joint infection","2026-05-29",{"date":77,"type":43},"2026-06-01",{"date":79,"type":43},"2025-09-24",{"date":81,"type":22},"2026-09-24",{"name":83,"class":84},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":85},"100617925","phase-1-methylene-blue-in-total-knee-arthroplasty-tka-100617925","NCT07324954","Methylene Blue in Total Knee Arthroplasty (TKA)","Impact of Irrigation Volumes in Revision Total Knee Arthroplasty (TKA) Surgical Washout: A Pilot Study","Inclusion Criteria:\n\n* Primary Total Knee Arthroplasty (TKA) or Primary Total Knee Arthroplasty (TKA) with Prosthetic Joint Infection (PJI)\n* 18 years\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Incomplete irrigation documentation\n* Patients with severe immunosuppression (example: chemotherapy, neutropenia, Human Immunodeficiency Virus \\[HIV\\], steroid use)\n* Positive fungal, parasitic, or mycobacterial cultures\n* Methylene Blue allergy\n* Patients on Monoamine Oxidase (MAO) inhibitors, Selective Serotonin Reuptake Inhibitors (SSRI), Selective Norepinephrine Reuptake Inhibitors (SNRI), and\u002For Tricyclic Antidepressants (TCA)\n* History of methemoglobinemia\n* Glucose-6-Phosphate (G6P) Enzyme Deficiency\n* Chronic Kidney disease or Glomerular Filtration Rate (GFR) less than 30mL\u002Fmin\n* Prisoners\n* Pregnant Woman",{"count":94,"type":22},20,[96],"PHASE1","The purpose of this pilot study is to determine the volume of irrigation required to achieve macroscopic clearance of contaminants during a debridement, antibiotics, and implant retention (DAIR) procedure for periprosthetic joint infection (PJI) of the knee. Given the lack of robust data guiding irrigation volume in this setting, the investigator proposes to use the application of methylene blue dye intraoperatively to simulate contaminant presence. Serial irrigation will be performed, with photographic documentation taken every 2,000mL until visible dye clearance is achieved. This study aims to identify the irrigation volumes that result in gross clearance of simulated contamination, thereby informing the design and stratification of a future randomized controlled trial (RCT) evaluating irrigation strategies in DAIR procedures.",[99,29,100],"Total Knee Arthroplasty","Irrigation","2026-04-10",{"date":103,"type":43},"2026-04-14",{"date":105,"type":43},"2026-02-04",{"date":107,"type":22},"2027-02-01",{"name":109,"class":84},"University of Miami",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":121,"conditions":122,"keywords":126,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":85},"100538631","real-component-vs-all-cement-articulating-spacers-for-periprosthetic-knee-infection-100538631","NCT06293352","Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection","Durable, Real-component Antibiotic Spacers vs All-cement Articulating Spacers for the Treatment of Periprosthetic Knee Infection","Inclusion Criteria:\n\n* Patients diagnosed with a chronic periprosthetic joint infection after a primary total knee arthroplasty with plan for explant and placement of an antibiotic spacer\n* PJI defined according to Musculoskeletal Infection Society (MSIS) 2018 Consensus Criteria\n\nExclusion Criteria:\n\n* Patients who are unable to consent\n* Infection at site of revision TKA\n* Soft tissue envelope compromise\n* Allergies to study materials (cement, vancomycin, tobramycin)\n* Incompetent extensor mechanism\n* Extensive bone loss\n\nRandomization-specific exclusion criteria\n\n* Extensive soft tissue defect\n* Extensor mechanism compromise",{"count":118,"type":22},153,[120],"NA","In the US, if an infection in an artificial knee joint doesn't heal with antibiotics alone, the standard treatment is a two-stage revision of the artificial knee. In the first stage, the surgeon will remove the artificial knee and clean out the area around the knee. They will then place an antibiotic spacer. An antibiotic spacer is a type of artificial joint that will release antibiotics into the knee space continuously over time. The spacer allows only very basic function of the knee. The patient may need to use crutches or a walker while the antibiotic spacer is in place. After surgery to place the antibiotic spacer, the surgeon may prescribe a course of antibiotics as well. Because the antibiotic spacer is not as durable as a regular artificial joint, after the infection is gone, another surgery is required to take the spacer out and put a new artificial knee joint in.\n\nThere is another way for artificial joint infections to be treated. This is a one-stage revision. In this treatment, the surgeon will remove the artificial knee and clean out the area around the knee. Then the surgeon will place a new artificial knee in using a special kind of cement that contains antibiotics. The cement will release antibiotics into the knee space continuously over time (the surgeon may prescribe a course of antibiotics as well). The new artificial joint with antibiotic cement will function almost the same as the original artificial knee. This means that while the infection is healing the patient will be able to do most of the regular daily activities. However, the antibiotic cement is not as durable as what is normally used to implant an artificial knee. The artificial knee with the antibiotic cement may need to be replaced with a regular artificial knee. When replacement will need to be done is dependent on patient weight, bone strength and activity level, among other things. When it is time to replace the antibiotic cement artificial knee, the patient will have another surgery where the surgeon will take the antibiotic cement artificial knee and put a new artificial knee joint in.\n\nInvestigators know that both the one- and two-stage revision work equally well to heal the infection, but investigators don't know which patients prefer or which provides better function after many years. This study will randomly assign patients to receive either a one-stage or two-stage revision and then follow them for 5 years to ask them about pain, function, and satisfaction.",[29,123,124,34,125],"Knee Infection","Arthroplasty Complications","Arthroplasty, Replacement, Knee",[127,128],"randomized trial","patient-reported outcomes","2026-03-20",{"date":131,"type":43},"2026-03-24",{"date":133,"type":43},"2024-08-08",{"date":135,"type":22},"2026-12",{"name":137,"class":84},"Northwestern University",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":149,"conditions":150,"keywords":155,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":164,"leadSponsor":166,"locationsCount":85},"100617720","antibiotic-coated-braided-suture-study-100617720","NCT07322289","Antibiotic-coated Braided Suture Study","Evaluating the Use of Antibiotic-Coated Braided Sutures in Debridement, Antibiotic, and Implant Retention (DAIR) Procedures","Inclusion Criteria:\n\n* Age ≥18 years\n* Willing and able to provide informed consent\n* Primary Total Hip Arthroplasty or Total Knee Arthroplasty with Prosthetic Joint Infection Musculoskeletal Infection Society (MSIS) criteria\n* Prosthetic Joint Infection Treated with Debridement, Antibiotics, Implant Retention\n\nAcute Prosthetic Joint Infection: \\\u003C4 weeks since it was suspected\u002Fdiagnosed\n\nExclusion Criteria:\n\n* Staphylococcus aureus bacteremia\n* Mycobacterial, fungal, or parasitic infection\n* Concurrent infection needing prolonged Intravenous therapy\n* Septic shock\u002Fsystemic illness needing IV therapy\n* Patients with severe immunosuppression (ex: chemotherapy,\n\nneutropenia, HIV, steroid use\n\n* Allergy to Triclosan\n* Pregnancy\n* Prisoners","89 Years",{"count":147,"type":22},142,[120],"The purpose of this study is to evaluate whether the use of antibiotic-coated (triclosan) braided sutures is non-inferior or potentially superior to standard monofilament sutures in patients with prosthetic joint infections (PJIs) managed with the DAIR protocol. Several studies in various surgical specialties have demonstrated the effectiveness and non-inferiority of triclosan-coated braided sutures in infected surgical cases, and the study intends to transpose this idea to the management of prosthetic joint infections. Monofilament sutures are the present standard of care in any infected joint case due their lower surface area for bacterial harborization, though surgeons sacrifice mechanical integrity and comfortability with the closure in the process. By demonstrating the safety of antibiotic -coated braided sutures, surgeons will no longer have to make this compromise.",[67,151,152,153,154],"Debridement With Prosthesis Retention","Prosthetic Joint Infections of Hip","Prosthetic Joint Infections of Knee","Suture",[74,156,157,158],"debridement, antibiotics, implant retention","antibiotic coated braided sutures","monofilament suture","NOT_YET_RECRUITING","2026-03-18",{"date":162,"type":43},"2026-03-23",{"date":40,"type":22},{"date":165,"type":22},"2027-12-31",{"name":109,"class":84},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":174,"targetDuration":176,"studyType":62,"phases":4,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":85},"100439317","long-term-follow-up-of-patients-with-prosthetic-joint-infection-of-the-hip-treated-at-university-hospitals-leuven-100439317","NCT05000723","Long Term Follow-up of Patients With Prosthetic Joint Infection of the Hip Treated at University Hospitals Leuven","PROFITH","Inclusion Criteria:\n\n* 18 years or older\n* patients diagnosed with PJI of the hip based on EBJIS 2021 criteria\n\nExclusion Criteria:\n\n* Patients unable to provide written informed consent\n* Patients who prefer treatment outside of University Hospitals Leuven\n* Patients with infections of the native hip joint\n* Patients with fracture-related infections (FRI)\n* Patients with uncertain diagnosis of PJI according to the 2021 EBJIS criteria\n* Patient younger than 18 years",{"count":175,"type":22},50,"5 Years","Prosthetic Joint Infection (PJI) of a Total Hip Replacement (THR) is a disastrous complication of an otherwise extremely successful surgical procedure. It is associated with a burdensome treatment for the patient, significant challenges for the medical team and high costs for society. As more joint replacements are being performed each year, due to an ageing population and lower thresholds for surgery, the number of PJIs is on the rise. Many of these patients will be referred to University Hospitals Leuven as the physicians have extensive experience with this particular pathology and can offer a multidisciplinary and patient-tailored treatment. Many controversies exist in the field of PJI treatment, both with regard to the surgical aspects as well as the antibiotic treatment. Setting up randomized controlled trials to answer these questions has been proven to be very difficult due to large variations in patients, implants, germs, soft and hard tissues, antibiotic resistance patterns, and so on. Also, surgery for PJIs is usually non-elective \u002F semi-urgent and therefore time to include patients into different trials is limited. Therefore the investigators will prospectively collect data on patients with PJI treated at University Hospitals Leuven, starting 01\u002F01\u002F2022, in order to have knowledge of own results and inform patients about chances of success prior to treatment; perform internal audits and quality checks; answer questions in the field of PJI treatment not suitable for RCTs.",[67,179],"Hip Prosthesis Infection","2026-03-12",{"date":182,"type":43},"2026-03-16",{"date":184,"type":43},"2022-07-14",{"date":186,"type":22},"2099-12",{"name":188,"class":84},"Universitaire Ziekenhuizen KU Leuven",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":196,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":200,"conditions":201,"keywords":205,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":215,"locationsCount":85},"100624227","reduction-of-bacterial-seeding-in-total-shoulder-arthroplasty-100624227","NCT07406893","Reduction of Bacterial Seeding in Total Shoulder Arthroplasty","Reduction of Bacterial Seeding in Total Shoulder Arthroplasty: Prontosan Antimicrobial Gel Incision Preparation Versus No Preparation in Male Patients","Inclusion Criteria:\n\n* Adult male 18 years of age or older undergoing elective primary total shoulder arthroplasty, including both anatomic and reverse total shoulder arthroplasty, for indications including massive rotator cuffs, rotator cuff arthropathy, glenohumeral osteoarthritis, and acute fractures.\n\nExclusion Criteria:\n\n* Any revision shoulder arthroplasty procedure or other shoulder surgery that is not a primary shoulder arthroplasty.\n* Patients with allergy to active ingredients in Prontosan gel\n* Patient is unable to consent for themselves\n* Patient is non-English speaking\n* Females","MALE",{"count":198,"type":22},60,[120],"The purpose of this study is to compare the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary shoulder replacement when using a no-prep control group versus Prontosan wound gel applied to the skin layer after the skin incision has been made.",[202,203,204,67],"Joint Arthroplasty","Shoulder","Cutibacterium Acnes",[206,207,208],"Antimicrobial wound gel","Dermal layer","Skin preparation","2026-03-06",{"date":211,"type":43},"2026-03-10",{"date":213,"type":43},"2026-02-23",{"date":135,"type":22},{"name":216,"class":84},"St. Louis University",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":85},"100586786","the-effect-of-peri-operative-adjunctive-probiotics-on-immunological-markers-in-cases-of-prosthetic-joint-infection-of-the-hip-and-knee-100586786","NCT06919913","The Effect of Peri-Operative Adjunctive Probiotics on Immunological Markers in Cases of Prosthetic Joint Infection of the Hip and Knee","Inclusion Criteria:\n\n* Patients ages 18-90 years of age.\n* Diagnosis of PJI based upon Musculoskeletal Infection Society (MSIS) criteria\n* Planned treatment with surgical debridement, antibiotics, implant retention (DAIR), single- and two-stage revision total joint arthroplasty (TJA) for PJI with an anticipated plan for eventual discontinuation of oral\u002FIV antibiotics.\n* Patients with prior PJI in the same joint that has recurred.\n* Patients who understand the benefits and risks associated with taking a probiotic and are willing and able to provide informed consent.\n\nExclusion Criteria:\n\n* Fungal PJI.\n* Inflammatory bowel disease, diverticulitis, history of intestinal surgery, or gastrointestinal issue where there is concern for gut integrity.\n* Severe acute gastrointestinal diseases (active bowel leak, acute colitis, acute pancreatitis).\n* Active endocarditis.\n* History of pancreatitis\n* History of intolerance to probiotics.\n* Patients that are pregnant or lactating.\n* Immunocompromised patients and patients with immunosuppressive conditions (uncontrolled HIV, chemotherapy for cancer treatment, stem cell transplantation, immunosuppressive medications for solid organ transplant, systematic corticosteroid use, immunosuppressive medications for autoimmune dysfunction, and neonates).\n* Patients who are critically ill.\n* Revision TJA for aseptic reasons.","90 Years",{"count":225,"type":22},152,[120],"The purpose of this study is to determine whether probiotics in addition to standard of care (SOC) can improve immunological markers following treatment for prosthetic joint infection (PJI). The study aims to determine whether probiotics in addition to SOC decrease immunological markers following treatment for PJI, improve medical and surgical complications and mortality in patients with PJI, and lead to improved gastrointestinal (GI)-specific patient reported outcomes measures (PROMs) in patients with PJI.",[29],"2026-03-02",{"date":231,"type":43},"2026-03-04",{"date":233,"type":43},"2025-07-12",{"date":235,"type":22},"2027-01-01",{"name":237,"class":84},"NYU Langone Health",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":247,"studyType":62,"phases":4,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":4},"100625733","delafloxacin-plasma-and-tissue-concentration-in-patients-with-skin-soft-tissue-and-bone-and-joint-infections-100625733","NCT07426471","Delafloxacin Plasma and Tissue Concentration in Patients With Skin, Soft Tissue, and Bone and Joint Infections.","Delafloxacin Plasma and Tissue Concentration in Patients With Skin, Soft Tissue, and Bone and Joint Infections: a Prospective Mono-center Observational Pharmacological Study.","DELA-PLAT","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study, and to be concurrently enrolled in the Institutional Infectious Disease Biobank (INDI-REBIO, NCT06418048)\n* \\>18 years-old\n* eGFR of \\> 80 mL\u002Fmin\u002F1,73m2\n* Receiving delafloxacin 300mg q12h IV according to treating physician's choice and good clinical practice or available guidelines with bacterial skin and skin structure infection and with\n\n  1. post-sternotomy wound infection and\u002For mediastinitis undergoing surgical debridement\n  2. prosthetic joint infections undergoing surgical debridement or prosthetic joint removal (either one-stage, e.g. when the Infected prosthesis is removed and a new one is implanted in the same surgery, or two-stage, when the Infected prosthesis is removed, followed by a period of antibiotics, then a new prosthesis is implanted in a second surgery).\n\nExclusion criteria:\n\n* Patients who received other quinolones (oral or IV) in the week preceding the sample collection\n* Patients who decline or are unwilling to participate in serial blood draws at all five designated time points.\n* Pregnant or lactating women",{"count":94,"type":22},"1 Day","The goal of this observational study is to measure how well the antibiotic delafloxacin penetrates into the blood and various body tissues in adult patients over 18 years old. Specifically, this study focuses on patients who are receiving the drug to treat bacterial infections and are undergoing surgery for post-sternotomy wound infections, mediastinitis, or infected prosthetic joints .\n\nThe main questions it aims to answer are:\n\n* What is the concentration of delafloxacin in the blood plasma?\n* What is the concentration of delafloxacin in different body tissues, including soft tissue, tissue around a prosthetic implant, joint fluid (synovial fluid), and bone ?\n* How does the concentration of the drug in the blood compare to its concentration in the tissues?\n* Do patient factors such as age, body weight, and kidney function affect the drug's levels in the body?\n\nParticipants will:\n\n* Continue to receive delafloxacin (300mg intravenously every 12 hours) as prescribed by their treating physician for their infection.\n* Allow researchers to draw 5 peripheral blood samples (about 10 mL total) at specific times (15 minutes, 1 hour, 3 hours, 5-7 hours, and 11 hours) after the end of a single delafloxacin infusion.\n* Allow researchers to collect small amounts of tissue and joint fluid for testing during their already planned surgical procedure.",[250,251,252,67],"Soft Tissue Infections","Mediastinitis","Osteomyelitis\u002FSeptic Arthritis","2026-02-20",{"date":213,"type":43},{"date":256,"type":22},"2026-04-01",{"date":258,"type":22},"2027-01-31",{"name":260,"class":84},"IRCCS San Raffaele",{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":271,"conditions":272,"keywords":273,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":283,"leadSponsor":285,"locationsCount":85},"100624420","study-of-the-lived-experience-of-patients-with-prosthetic-joint-infection-their-families-and-healthcare-professionals-development-of-a-therapeutic-education-program-for-patient-care-tep-100624420","NCT07409402","Study of the Lived Experience of Patients With Prosthetic Joint Infection, Their Families, and Healthcare Professionals. Development of a Therapeutic Education Program for Patient Care (TEP).","Study of the Lived Experience of Patients With Prosthetic Joint Infection, Their Families, and Healthcare Professionals. Development of a Therapeutic Education Program for Patient Care - PROTHEE-QUALI : QUALITATIVE STUDY","PROTHEE-QUALI","Inclusion Criteria:\n\nPatients :\n\n* Age ≥ 18 years\n* Have undergone surgery \\> 1 month and \\\u003C 1 year ago for a hip, knee, or shoulder prosthetic implant, and are currently receiving or have received prolonged antibiotic therapy (≥ 6 weeks)\n* Patients had to agree to sign a consent form to participate in the study.\n\nPatient companions :\n\n* Age ≥ 18 years\n* Close relative or friend designated by the patient, who has accompanied them throughout their care journey, from diagnosis, during and after hospitalization, at least until the end of antibiotic treatment\n* Not opposed to participating in the study\n\nHealthcare professionals :\n\n* Practicing for ≥ 1 year in a CRIOAC (Reference Center for Osteoarticular Infections)\n* Role: nurse, physiotherapist, psychologist, pharmacist\n* Not opposed to participating in the study\n\nExclusion Criteria:\n\nPatients :\n\n* Do not have proficiency in the French language\n* Patients with advanced cognitive disorders\n* Patients with severe depression\n\nPatient companions :\n\n* Do not have proficiency in the French language\n* Patients with advanced cognitive disorders\n* Patients with severe depression\n\nHealthcare professionals :\n\n-None",{"count":270,"type":22},63,"The PROTHEE-QUALI study (Qualitative study of the lived experience of patients with prosthetic joint infection, their accompanying persons and health professionals and construction of a therapeutic education program for management: qualitative study) is categorized as non-interventional qualitative research.\n\nIn France, a prosthetic joint infection (PJI) is diagnosed in approximately 3000 patients per year. This complication is severe and results in major consequences for the patient, such as prolonged or repeated hospitalization, pain, anxiety, and a transient or permanent loss of autonomy, sometimes resulting in disability, or even amputation or joint resection. PJI management is complex, necessitating a multidisciplinary approach combining surgical treatment and prolonged antibiotic therapy (lasting from 6 to 12 weeks to several months).\n\nThe PROTHEE-QUALI project was designed to create this essential tool by collecting and crossing the perspectives of the affected patients, their accompanying persons, and the healthcare professionals involved.\n\nThe general objective of the project is the structuring of a TPE program destined for patients with PJI, aiming to improve their management and support. This includes assistance with adherence to and better tolerance of antibiotic treatments, pain management, physical rehabilitation, psycho-social care, providing information on the infection and its evolution, and adapting hygiene measures.\n\nThe primary objective is the exploration of the lived experience of patients with PJI, their accompanying persons, and the health professionals (nurses, physiotherapists, psychologists, and pharmacists) taking care of them in real-life settings.\n\nThe secondary objective is the structuring of a TPE program based on the crossed perspectives of patients, their accompanying persons, and health professionals concerning the issue of PJI.\n\nPROTHEE-QUALI is an 18-month prospective multicenter qualitative study. It uses the IPSE qualitative research method (\"Inductive process to analyze the structure of lived experience\"). The design involves two main phases: Phase 1 focuses on exploring the experience through individual interviews (patients and accompanying persons) and focus groups (health professionals) to extract a structure of experience; Phase 2 involves the validation and elaboration of the TPE program proposal through feedback from new focus groups. The sampling technique used is non-probabilistic and intentional, known as \"purposive sampling\" with maximum variation, seeking exemplary situations and rich, diversified accounts rather than statistical representativeness.\n\nInvolved Structures The research is promoted by the Assistance Publique - Hôpitaux de Paris (AP-HP), with the Délégation à la Recherche Clinique et à l'Innovation (DRCI) ensuring the promoter's missions by delegation. The study is funded by a grant from GIRCI APRESO Convergence 2024.\n\nThe research is multicentric, involving three investigating centers which are Complex Osteoarticular Infection Reference Centers (CRIOACs) in the Île de France region:\n\n* The CRIOAC of the Groupe Hospitalier Diaconesses Croix Saint-Simon.\n* The CRIOAC Lariboisière Saint Louis.\n* The CRIOAC Cochin. The qualitative and methodological team includes members of the INSERM U1153, Statistic and epidemiologic research center Sorbonne Paris Cité. The monitoring of the research is overseen by a Clinical Research Unit (URC).",[67],[274,275,276,277,278],"Prosthetic joint infection","Lived experience","Qualitative research","Therapeutic patient education","IPSE method","2026-02-06",{"date":281,"type":43},"2026-02-13",{"date":229,"type":22},{"date":284,"type":22},"2027-09-02",{"name":83,"class":84},{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":296,"conditions":297,"keywords":298,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":85},"100428375","periprosthetic-joint-infections-diagnostic-accuracy-and-cost-effectiveness-analysis-of-serum-and-synovial-markers-100428375","NCT04858217","Periprosthetic Joint Infections: Diagnostic Accuracy and Cost-effectiveness Analysis of Serum and Synovial Markers","Diagnostic Accuracy and Cost-effectiveness Analysis of Serum and Synovial Fluid Markers for the Diagnosis of Periprosthetic Hip and Knee Joint Infections","DECISION","Inclusion Criteria:\n\n* Patients requiring hip or knee replacement surgery: i) for 'late' joint prosthesis infection, present for at least 90 days from the date of the arthroplasty (first surgical phase); II) for non-infectious causes (mobilization, wear, instability, misalignment, adverse reactions to local tissues or other aseptic causes), also present for at least 90 days, and which have not had other re-operations on the same joint, and which will be a one-step review;\n* Previous clinical data and laboratory and radiological examinations available.\n\nExclusion Criteria:\n\n* Patients affected by 'early' joint prosthesis infection, with clinical symptom latency of less than 90 days (in this specific subset of patients there is in fact still considerable heterogeneity and little consensus about the diagnostic levels of white blood cell count and percentage of neutrophils).\n* Patients suffering from joint prosthesis infection involving joints other than the hip or knee.\n* Severe cognitive impairment or psychiatric disorders;\n* Pregnant women.",{"count":295,"type":22},270,"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\u002For 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.",[67],[74,299,300,301],"biomarker","synovial fluid","serum","2025-09-19",{"date":304,"type":43},"2025-09-22",{"date":306,"type":43},"2022-02-01",{"date":308,"type":22},"2026-03-31",{"name":310,"class":84},"Istituto Ortopedico Rizzoli",{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":318,"targetDuration":4,"studyType":23,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":4},"100561559","pca-administration-in-prosthetic-joint-infection-100561559","NCT06591741","PCA Administration in Prosthetic Joint Infection","Effects of Dietary Protocatechuic Acid (PCA) on the Function and Structure of Participants With Knee Prosthetic Joint Infection (PJI) as Measured by Standard Biomarkers","Inclusion Criteria:\n\n* 3 weeks or more after total knee arthroplasty\n* One or more symptoms of infection, including redness, swelling, pain, increasing range of motion loss, fever, nausea, and loss of appetite.\n* WBC count of aspirate \\>50,000 cells per μL\n\nExclusion Criteria:\n\n* Not willing to undergo blood draw at 3 months.",{"count":319,"type":22},100,[120],"Determine if dietary protocatechuic acid (PCA) will affect health biomarkers in patient undergoing revision surgery for a knee prosthetic joint infection",[67],"2025-08-18",{"date":325,"type":43},"2025-08-20",{"date":327,"type":22},"2026-01",{"date":329,"type":22},"2028-12",{"name":331,"class":84},"Dr. Dean Reeves Clinic",{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":23,"phases":342,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":85},"100452263","phase-2-antibiotic-impregnated-bone-graft-to-reduce-infection-in-hip-replacement-100452263","NCT05169229","Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.","Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement. The ABOGRAFT Trial","ABOGRAFT","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Hip arthroplasty requiring bone graft\n3. Willing to provide informed consent.\n4. For women of childbearing potential; a negative pregnancy test prior to reoperation.\n\nExclusion Criteria:\n\n1. Ongoing prosthetic joint infection\n2. Known allergies and contraindications for the use of vancomycin or tobramycin\n3. Mental inability, reluctance, or language difficulties that according to investigator judgement, result in difficulty understanding the meaning of study participation\n4. Expected difficulties to complete 2-year follow-up\n5. Females of child bearing potential not using contraception\n6. Pregnant females\n7. Nursing females",{"count":341,"type":22},1100,[25,26],"Total hip replacement is the most successful treatment modern healthcare can offer patients to regain quality of life. Periprosthetic joint infection (PJI) is the most common and devastating complication after total hip replacement (THR). Between 0.5 to 2% of primary THR (first time hip replacement), and 8-10% of revision THR (replacement of a hip prosthesis) will become infected.1 The introduction of local antibiotics blended into bone cement has led to a reduction in postoperative infection in primary THR by half.2 Unfortunately, cement can't always be used in relevant quantities.\n\nThe number of primary and revision surgeries of the hip is projected to increase dramatically. Therefore, the need for a feasible infection prophylaxis that is applicable for complex primary and revision THR in addition to antibiotics loaded cement is urgent.\n\nImpacted morselized bone allograft is often used in (revision) THR to fill bone defects. Morselized allograft has been used as a carrier for local antibiotic treatment in multiple pilot studies and appears to be an attractive and effective treatment option, both for already infected joints and as a prophylactic measure in high-risk patients (e.g. THR revision surgeries). Nonetheless, a pivotal trial to support its use in THR is lacking. The aim of this pragmatic randomized controlled double blinded drug trial is to investigate whether antibiotic impregnated bone graft (AIBG) decreases the risk of infection after hip arthroplasty compared to controls treated with placebo impregnated bone graft. Patients scheduled for elective THR will be randomized to receive AIBG or a placebo impregnated bone graft. The primary outcome variable will be the number of re-operations due to infections and PJI diagnoses 2 years postoperative.",[345,346,347,67],"Arthroplasty, Replacement, Hip","Osteoarthritis, Hip","Antibiotic Resistant Infection","2025-07-17",{"date":350,"type":43},"2025-07-22",{"date":352,"type":43},"2022-04-01",{"date":354,"type":22},"2031-12",{"name":356,"class":84},"University Hospital, Linkoeping",{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":23,"phases":365,"briefSummary":366,"conditions":367,"keywords":368,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":381},"100488584","short-interval-full-two-stage-implant-exchange-100488584","NCT05642013","SHort Interval Full Two-stage Implant Exchange","SHIFT","Inclusion Criteria:\n\nProspective group:\n\n* Patient over 18 years old\n* Patient managed for a definite osteoarticular infection in a hip or knee prosthesis according to EBJIS definitions (2021) Clinical definition : fistula communicating with the prosthesis, prosthesis exposed \u002F Or biological ≥ 2 samples positive for the same microorganism \u002F And\u002F or 3000 leukocytes or \\> 80% of PNN on the synovial fluid \u002F Or histological: visible microorganism, \\> or = 5 PNN on 5 HPN\n* Patient with an indication for 2-stage surgery:\n\nA Impossibility of conservative treatment : infection occurring more than 4 weeks after prosthesis implantation, fistula, documented resistant germ, loosened prosthesis \u002F B Unsuitable 1-stage change: recurrence after 1-stage management, precarious bone capital, documented resistant microorganism, infection without prior microbiological documentation, fistula, surgeon's assessment in disfavor\n\n\\- Effective contraception during the research period for fertile women of childbearing age\n\nRetrospective group :\n\n* Patient managed before 31\u002F12\u002F2021 for a definite osteoarticular infection in a hip or knee prosthesis according to EBJIS definitions (2021) Clinical definition : fistula communicating with the prosthesis, prosthesis exposed Or biological ≥ 2 samples positive for the same microorganism And\u002F or 3000 leukocytes or \\> 80% of PNN on the synovial fluid Or histological: visible microorganism, \\> or = 5 PNN on 5 HPN\n* Patient managed by 2 \"long\" stage surgery with reimplantation time \\> 6 weeks with an evolutionary follow-up of at least 15 months after the end of antibiotics\n\nExclusion Criteria:\n\nProspective group :\n\n* Indication for conservative treatment, 1-stage or 2 long stage surgery\n* Reimplantation by another surgical approach requiring complete skin closure of the initial scar\n* Other surgeries scheduled within 30 days of removal\n* Participation in another interventional treatment study and\u002For in an exclusion period due to participation in another protocol\n* Subject not affiliated with a social security plan or beneficiary of such a plan\n* Failure to obtain written informed consent\n* Patient with a legal protection measure (guardianship, curatorship)\n* Patient under justice safeguard\n* Pregnant or breastfeeding woman\n\nRetrospective group :\n\n\\- Refusal to participate\n\nStudy exit criteria\n\n* Bacteriological samples positive for fungi\n* Infection not retained after analysis of samples (no sufficient clinical or biological criteria according to EBJIS definition)\n* Withdrawal of consent",{"count":319,"type":22},[120],"This study is a prospective bicentric feasibility study, which aims to evaluate the feasibility of a two-stage full implant exchange with early prosthesis reimplantation between 16 and 30 days after implants removal for hip or knee prosthetic joint infection.\n\nThis study concern 50 patients, prospectively included and compared to the last 50 patients with hip or knee PJI managed with classical two-stage implant exchange.\n\nThe duration of the study is 42 months.",[29],[74,369,370,371],"knee","hip","two-stage exchange","2024-08-02",{"date":374,"type":43},"2024-08-06",{"date":376,"type":43},"2023-01-23",{"date":378,"type":22},"2027-07-23",{"name":380,"class":84},"University Hospital, Montpellier",2,{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":23,"phases":392,"briefSummary":394,"conditions":395,"keywords":398,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":51},"100529302","phase-4-rifampicin-combination-therapy-versus-monotherapy-for-staphylococcal-prosthetic-joint-infection-100529302","NCT06172010","Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint Infection","Rifampicin Combination Therapy Versus Targeted Antimicrobial Monotherapy in the Oral Antimicrobial Treatment Phase of Staphylococcal Prosthetic Joint Infection","RiCOTTA","Inclusion Criteria:\n\n* \\>18 years of age\n* Confirmed staphylococcal prosthetic hip or knee joint infection according to the current EBJIS 2021 definition of PJI\n* The causative agents are (or include) S. aureus or and\u002For Coagulase-negative staphylococci (CNS)\n* Treatment is according to the DAIR-procedure\n\nExclusion Criteria:\n\n(i) a contra-indication for rifampicin (e.g. a resistant strain or proven allergic reaction or difficult drug-drug-interactions) (ii) complicated S. aureus bacteremia or concurrent endocarditis requiring long-term iv antibiotic treatment \\> 2 weeks (iii) An infection for which there are no suitable antibiotic choices to permit Randomization between the two arms of the trial (for instance, where organisms are only sensitive to intravenous antibiotics) (iv) treatment failure before the start of oral therapy, (v) an unsatisfactory response to initial treatment leading to continuation of intravenous therapy beyond day 21, (vi) patients with an expected life expectancy \\\u003C12 months, (vii) patients with a tumor prosthesis (viii) patients receiving chemotherapy for active malignancy in the next 12 months (ix) patients who are scheduled in advance for chronic suppressive antibiotic therapy for \\>12 months, (x) The patient is unlikely to comply with trial requirements following Randomization in the opinion of the investigator (xi) Pregnancy (xii) Patients who are not able to read or communicate in Dutch or English will be excluded from participating in this study",{"count":391,"type":22},316,[393],"PHASE4","In this Dutch multicenter clinical trial, patients with a staphylococcal prosthetic joint infection, will, in the oral antibiotic treatment phase, be randomized between clindamycin monotherapy and rifampicin \u002F levofloxacin combination therapy. The clinical endpoint will be treatment success one year after finishing antimicrobial treatment.",[29,396,397],"Infection Hip","Infection; Knee, Joint",[399,400,401,74,402],"rifampicin","clindamycin","levofloxacin","antimicrobial treatment","2023-12-06",{"date":405,"type":43},"2023-12-15",{"date":407,"type":43},"2023-04-01",{"date":409,"type":22},"2028-03",{"name":411,"class":84},"Leiden University Medical Center",{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":85},"100309344","quality-of-life-in-patients-having-a-prosthetic-joint-infection-100309344","NCT03307109","Quality of Life in Patients Having a Prosthetic Joint Infection","QuaVIPA","Inclusion Criteria:\n\n* Patient having prosthetic joint infection\n* Patient who did not object to participate in the study\n* Patients over 18 years of age\n\nExclusion Criteria:\n\n* Patient with additional psychological or psychiatric support outside the service.\n* Patient benefiting from a system of legal protection (safeguard of justice, guardianship, curatorship)\n* Patient participating in another study on measuring quality of life\n* Patients with cognitive impairment to understand the questionnaire\n* Impossibility of giving the patient informed information\n* Patients with no infection diseases follow up at the CROIX ROUSSE hospital\n* Patients with amputation as initial surgery for infection management",{"count":420,"type":22},250,"Bone and joint infections (BJI) are rare serious pathology which can lead to a very heavy handicap and sometimes to the life threatening. These are devastating diseases whose diagnosis is difficult. They are known to be associated with high mortality rates (5%) and significant morbidities responsible for functional sequelae (40% of patients) with an individual cost (prolonged hospitalization, altered quality of life) and societal (work stoppage, partial or total disability, temporary or permanent) extremely high.\n\nThese bone and joint infections have a significant impact on the quality of life of those affected who, in addition to their infection, are reduced in their autonomy and often need to be taken care of outside their home, sometimes away from home.\n\nTo the knowledge of investigators, there are few studies on the measurement of quality of life in patients with osteoarticular infection.\n\nThe aim of this study is to implement the EQ-5D-3L validated quality of life questionnaire and the EVA scale (created by EuroQol Group) for each patient with a prosthetic joint infection (IPA) on prosthesis during their medical care in the department of Infectious and Tropical Diseases.",[423,67],"Quality of Life","2023-10-16",{"date":426,"type":43},"2023-10-17",{"date":428,"type":43},"2017-10-17",{"date":430,"type":22},"2028-10",{"name":432,"class":84},"Hospices Civils de Lyon",{"id":434,"slug":435,"hasResults":11,"nctId":436,"briefTitle":437,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":442,"conditions":443,"keywords":445,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":85},"100418122","phage-safety-retrospective-cohort-study-100418122","NCT04724603","Phage Safety Retrospective Cohort Study","PHASACO-retro","Inclusion Criteria:\n\n* patients having had a bone or joint or implant infection treated by phagotherapy and having had an adverse event\n\nExclusion Criteria:\n\n\\-",{"count":441,"type":22},25,"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.",[444,67],"Bone and Joint Infection",[446,447,448,67],"bone and joint infection","phagotherapy","adverse event","2023-04-12",{"date":451,"type":43},"2023-04-13",{"date":453,"type":43},"2021-02-01",{"date":455,"type":22},"2026-09-01",{"name":432,"class":84},{"id":458,"slug":459,"hasResults":11,"nctId":460,"briefTitle":461,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":465,"conditions":466,"keywords":468,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":85},"100412442","phage-safety-cohort-study-100412442","NCT04650607","Phage Safety Cohort Study","PHA-SA-CO","Inclusion Criteria:\n\n* Patient 18 years of age or older with a serious infection treated at CRIOAc Lyon by phage therapy\n* Patient who did not object to participating in the study\n* Patients ayant un poids minimum de 46kg\n\nExclusion Criteria:\n\n* Patients under guardianship\u002Fcuratorship\n* Patients deprived of liberty\n* Pregnant or breastfeeding women",{"count":319,"type":22},"This cohort study aims to describe the adverse events related to the use of bacteriophages to treat serious infections, data from the literature being almost non-existent on this subject.",[67,467],"Severe Infection",[469,448,470,471],"phage","severe infection","compassionate treatment",{"date":451,"type":43},{"date":474,"type":43},"2022-05-09",{"date":476,"type":22},"2028-05-09",{"name":432,"class":84},{"id":479,"slug":480,"hasResults":11,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":85},"100270533","cohort-of-prosthetic-joint-infections-100270533","NCT02801253","Cohort of Prosthetic Joint Infections","Prospective Cohort of Patients With Prosthetic Joint Infection","COPINS","Inclusion Criteria:\n\n* Patient aged over 18 years old with hip, knee and or shoulder joint prosthesis who consented to participate in the study with:\n* According to musculoskeletal infection society definition: PJI is present when one of the major criteria exists or four out of six minor criteria.\n\nMajor Criteria:\n\n* Two positive periprosthetic cultures with phenotypically identical organisms, OR\n* A sinus tract communicating with the joint, OR\n\nMinor Criteria:\n\n* Elevated serum C-reactive protein (CRP) AND erythrocyte sedimentation rate (ESR)\n* Elevated synovial fluid white blood cell (WBC)\n* Elevated synovial fluid polymorphonuclear neutrophil percentage (PMN%)\n* The presence of pus in the joint without known cause\n* Positive histological analysis of periprosthetic tissue\n* A single positive culture\n\nOr a PJI which meets the following three criteria:\n\n* Medical story suggesting prosthetic joint infection.\n* The presence of pain either with or without swelling for more than 3 months unrelated to a mechanical cause.\n* Germ identification in a single sample of fluid aspiration or tissue culture.\n\n  * Or microbial growth in prosthesis sonication fluid culture greater than 50CFU\u002Fml.\n\nExclusion Criteria:\n\n* Patient who does not meet eligibility criteria.\n* Patient lawfully deprived of his liberty.\n* Patient not insured under social security scheme.",{"count":487,"type":22},800,"Management of prosthetic joint infections (PJI) is a challenging task. These infections include different clinical and microbiological settings calling upon various treatment strategies according to infection type (acute or chronic), bone quality, the involved micro-organism and the patient's general condition and willing.\n\nTreatment of PJI combines surgery and prolonged antibiotic therapy. In some patients with a high operative risk prolonged suppressive antibiotic therapy can be used.\n\nLack of large prospective studies motivated the conception of this cohort with a long term follow up, regardless to PJI management procedures.",[67],"2022-03-28",{"date":492,"type":43},"2022-03-29",{"date":494,"type":43},"2015-09-11",{"date":496,"type":22},"2029-09",{"name":498,"class":84},"Groupe Hospitalier Diaconesses Croix Saint-Simon"]