[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"knee-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:knee-infection":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100538631","real-component-vs-all-cement-articulating-spacers-for-periprosthetic-knee-infection-100538631",false,"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","ALL","18 Years",{"count":19,"type":20},153,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30],"Prosthetic-joint Infection","Knee Infection","Arthroplasty Complications","Joint Infection","Arthroplasty, Replacement, Knee",[32,33],"randomized trial","patient-reported outcomes","RECRUITING","2026-03-20",{"date":37,"type":38},"2026-03-24","ACTUAL",{"date":40,"type":38},"2024-08-08",{"date":42,"type":20},"2026-12",{"name":44,"class":45},"Northwestern University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100545240","evaluation-of-outcomes-of-the-triathlon-hinge-knee-thk-system-100545240","NCT06379321","Evaluation of Outcomes of the Triathlon Hinge Knee (THK) System","A Retrospective\u002FProspective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Hinge Knee (THK) System","Hinge","Inclusion Criteria:\n\n* The subject undergoes a primary or revision procedure implanting at least the Revision Baseplate portion of the Triathlon Hinge Knee System in accordance with the Indications for Use.\n* The subject has signed an Institutional Review Board (IRB)\u002FEthical Committee (EC)-approved, study-specific Informed Consent Form (ICF).\n* The subject is a male or non-pregnant female at the time of enrollment.\n* The subject agrees to comply with the protocol-mandated clinical evaluations.\n\nExclusion Criteria:\n\n* Any active or suspected latent infection in or about the knee joint; overt infection;\n* Distant foci of infection which may cause hematogenous spread to the implant site; rapid disease progression as manifested by joint destruction or bone resorption apparent on roentgenogram;\n* skeletally immature patients;\n* Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.\n* Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and\u002For fixation to the prosthesis.\n* Known or suspected sensitivity and\u002For allergy to any material in the device.\n* Conditions presenting an increased risk of failure include:\n* uncooperative patient or patient with neurologic disorder, incapable of following instructions;\n* osteoporosis;\n* metabolic disorders which may impair bone formation or cause bone loss;\n* osteomalacia; and,\n* previous arthrodesis.\n* A higher incidence of implant failure has also occurred in paraplegics, cerebral palsy and patients with Parkinson's disease.\n* Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.\n* The subject is a prisoner",{"count":56,"type":20},200,"OBSERVATIONAL","This study is a prospectively and retrospectively enrolled, post-market, open-label, non-randomized, single institution evaluation of clinical outcomes of primary or revision knee surgery patients who meet the eligibility criteria and received devices from the Triathlon Hinge Knee System according to its indications for use (IFU).\n\nClinical evaluation for all cases will include data collection of patient demographics, surgical details, early postoperative status, functional and clinical outcomes, and survivorship at 1, 2, 6, and 10-years.",[60,61,27],"Knee Arthropathy","Recurrence","2026-02-27",{"date":64,"type":38},"2026-03-02",{"date":66,"type":38},"2024-05-10",{"date":68,"type":20},"2034-05-10",{"name":70,"class":45},"The Cleveland Clinic",2,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":46},"100396789","impact-of-the-type-of-stabilization-in-the-two-stage-knee-reimplantation-on-reinfection---prospective-randomized-study-100396789","NCT04446676","Impact of the Type of Stabilization in the Two-stage Knee Reimplantation on Reinfection - Prospective, Randomized Study.","Inclusion Criteria:\n\n* second-stage of knee reimplantation\n* primary knee replacement in primary knee osteoarthritis\n* fulfillment of International Consensus Meeting 2018 infection criteria\n\nExclusion Criteria:\n\n* intraoperative bone defects Anderson Orthopedic Research Institute score \\>II\n* autoimmune disease\n* diabetes\n* peripheral vascular disease\n* congenital or acquired immunodeficiencies\n* lack of pathogens after first-stage\n* multi-bacterial infection\n* multidirectional instability\n* lack of patient consent",true,"90 Years",{"count":56,"type":20},[23],"Participants after first-stage of knee infection reimplantation will be assign to one of two groups: with stem vs. with sleeve. Investigators will check participants on clinical, laboratory and reinfection signs. The main hypothesis is that better mechanical stability of endoprosthesis with sleeves will support infection treatment.",[27],[85,86,87,88,89],"knee arthroplasty","infection","two-stage","sleeve","stem","2022-03-14",{"date":92,"type":38},"2022-03-15",{"date":94,"type":38},"2020-11-17",{"date":96,"type":20},"2027-01",{"name":98,"class":45},"Prof A Gruca Teaching Hospital"]