protocolSection identificationModule nctId: NCT06293352, orgStudyIdInfo id: STU00220012, briefTitle: Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, descriptionModule briefSummary: In the US, if you get an infection in your artificial knee joint that doesn't heal with antibiotics alone, the standard treatment is a two-stage revision of the artificial knee. In the first stage, your surgeon will remove your 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 in to the knee space continuously over time. The spacer allows only very basic function of the knee. You may need to use crutches or a walker while the antibiotic spacer is in place. After surgery to place the antibiotic spacer, your 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.There is another way for artificial joint infections to be treated. This is a one-stage revision. In this treatment, the surgeon will remove your artificial knee and clean out the area around the knee. Then they will place a new artificial knee in using a special kind of cement that contains antibiotics. The cement will release antibiotics in to the knee space continuously over time (your surgeon may prescribe a course of antibiotics as well). The new artificial joint with antibiotic cement will function almost the same as your original artificial knee. This means that while the infection is healing you will be able to do most of your 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 your weight, bone strength and activity level, among other things. When it is time to replace the antibiotic cement artificial knee, you will have another surgery where the surgeon will take the antibiotic cement artificial knee and but a new artificial knee joint in.We know that both the one- and two-stage revision work equally well to heal the infection, but we 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., conditionsModule conditions: Prosthetic-joint Infection, conditions: Knee Infection, conditions: Arthroplasty Complications, conditions: Joint Infection, conditions: Arthroplasty, Replacement, Knee, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 153, type: ESTIMATED, armsInterventionsModule interventions name: All-cement articulating spacer, interventions name: Durable, real-component articulating spacer, interventions name: Rigid Spacer, outcomesModule primaryOutcomes measure: 24 month Knee Injury and Osteoarthritis Outcome Score (KOOS), secondaryOutcomes measure: 6 week Knee Injury and Osteoarthritis Outcome Score (KOOS), secondaryOutcomes measure: 6 week 10-item PROMIS Global Health survey (PROMIS-10), secondaryOutcomes measure: 6 month Knee Injury and Osteoarthritis Outcome Score (KOOS), secondaryOutcomes measure: 6 month 10-item PROMIS Global Health survey (PROMIS-10), secondaryOutcomes measure: 12 month Knee Injury and Osteoarthritis Outcome Score (KOOS), secondaryOutcomes measure: 12 month 10-item PROMIS Global Health survey (PROMIS-10), secondaryOutcomes measure: 24 month 10-item PROMIS Global Health survey (PROMIS-10), otherOutcomes measure: Revision/reoperation for infection (defined by positive culture by MSIS criteria), otherOutcomes measure: revision for aseptic failure (defined by negative culture by MSIS criteria), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwestern Medicine, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Orthopaedic Surgery Research, role: CONTACT, phone: 312-695-0332, email: orthosurveys@nm.org, contacts name: Adam I Edelstein, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Kevin D Hardt, MD, role: SUB_INVESTIGATOR, contacts name: Linda I Suleiman, MD, role: SUB_INVESTIGATOR, contacts name: David W Manning, MD, role: SUB_INVESTIGATOR, contacts name: William C Thomas, MD, role: SUB_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False