[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538631":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":42,"locations":48,"responsibleParty":78,"collaborators":29,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":29,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":29,"enrollmentInfo":89,"targetDuration":29,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":102,"overallStatus":51,"whyStopped":29,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Northwestern University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"All-cement articulating spacer","ACTIVE_COMPARATOR","An articulating spacer with a tibial and femoral component made of cement using molds, that are cemented in place; use of highdose antibiotic cement (at least 2g\u002Fbatch, including vancomycin and tobramycin); use of dowels at discretion of surgeon; 6 weeks IV antibiotics; intent to reimplant definitive prosthesis if infection eradicated.",[13],"Device: All-cement articulating spacer",{"label":15,"type":10,"description":16,"interventionNames":17},"Durable, real-component articulating spacer","Uses metal (or ceramicized metal) on plastic for bearing surface; use of high-dose antibiotic cement (at least 2g\u002Fbatch, including vancomycin and tobramycin); no cones\u002Fsleeves, no pressurized cement in canal; use of stems\u002Fdowels\u002Faugments and level of constraint at discretion of surgeon; 6 weeks IV antibiotics; intent to leave in situ indefinitely\u002Funtil clinical failure.",[18],"Device: Durable, real-component articulating spacer",{"label":20,"type":6,"description":21,"interventionNames":22},"Observation","Patients who do not wish to be randomized or who meet the randomization-specific exclusion criteria will be offered enrolment into the non-randomized, prospective observational arm of the study. The participant and their surgeon will collaboratively decide which of the 2 treatments the participant will receive.",[13,18,23],"Device: Rigid Spacer",[25,30,33],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","Two-stage intervention",[9,20],null,{"type":26,"name":15,"description":31,"armGroupLabels":32,"otherNames":29},"Single stage intervention",[15,20],{"type":26,"name":34,"description":35,"armGroupLabels":36,"otherNames":29},"Rigid Spacer","Observation intervention",[20],[38],{"name":39,"affiliation":40,"role":41},"Adam I Edelstein, MD","Assistant Professor of Orthopaedic Surgery","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":29,"email":47},"Melissa J Shauver, MPH","CONTACT","312-472-6024","melissa.shauver@northwestern.edu",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Northwestern Medicine","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-87.65005,41.85003,{"lat":61,"lon":60},[64,68,69,72,74,76],{"name":65,"role":45,"phone":66,"phoneExt":29,"email":67},"Orthopaedic Surgery Research","312-695-0332","orthosurveys@nm.org",{"name":39,"role":41,"phone":29,"phoneExt":29,"email":29},{"name":70,"role":71,"phone":29,"phoneExt":29,"email":29},"Kevin D Hardt, MD","SUB_INVESTIGATOR",{"name":73,"role":71,"phone":29,"phoneExt":29,"email":29},"Linda I Suleiman, MD",{"name":75,"role":71,"phone":29,"phoneExt":29,"email":29},"David W Manning, MD",{"name":77,"role":71,"phone":29,"phoneExt":29,"email":29},"William C Thomas, MD",{"type":41,"investigatorFullName":79,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Adam Edelstein","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":90,"type":91},153,"ESTIMATED","INTERVENTIONAL",[94],"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.",[97,98,99,100,101],"Prosthetic-joint Infection","Knee Infection","Arthroplasty Complications","Joint Infection","Arthroplasty, Replacement, Knee",[103,104],"randomized trial","patient-reported outcomes","2026-03-20",{"date":107,"type":108},"2026-03-24","ACTUAL",{"date":110,"type":108},"2024-08-08",{"date":112,"type":91},"2026-12",{"name":5,"class":6},1]