[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zimmer, GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100657884","persona-revision-knee-system-emea-pmcf-study-100657884",false,"NCT07843966","Persona Revision Knee System EMEA PMCF Study","Post-Market Clinical Follow-Up Study to Provide Long-term Safety, Performance and Clinical Benefits Data of the Persona® Revision Knee System (Implants and Instrumentation)","Inclusion Criteria:\n\n* Patient qualifies for a revision knee arthroplasty with the Persona Revision Knee System. Full or partial\u002Fhybrid revision cases that fall within the revision knee indication are allowed to be included in the study (not first joint replacement).\n* Patient experiences severe knee pain and disability due to:\n\nThe salvage of previously failed knee surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.\n\n* One-stage revision performed for infection OR\n* Second stage (reimplantation) of a planned two-stage revision.\n* Patient is ≥ 18 years.\n* Patient is skeletally mature.\n* Patient is willing and able to complete scheduled follow-up evaluations as described in the Protocol and Informed Consent Form.\n* Patient has participated in the Informed Consent process and is willing and able to sign the Informed Consent Form.\n\nExclusion Criteria:\n\n* Patient received the study device for any condition not listed in the indications or in combination with a non-compatible device.\n* First Knee Replacement patients.\n* Patient with only inlay\u002Fbearing exchange\u002Frevision.\n* Patient requires simultaneous bilateral knee surgery for treatment of diagnosed condition.\n* Patient has any of the following contraindications:\n\n  * Any active or suspected latent infection in or about the knee joint or distant foci of infection which may cause hematogenous spread to the implant site: In any case, the infection needs to be treated prior to the revision surgery.\n  * Insufficient bone stock on femoral or tibial surfaces which cannot provide adequate support and\u002For fixation to the prosthesis.\n  * Skeletal immaturity.\n  * Neuropathic arthropathy.\n  * Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb.\n  * A stable, painless arthrodesis in a satisfactory functional position\n  * Severe instability secondary to the absence of collateral ligament integrity.\n  * Diagnosis of rheumatoid arthritis in conjunction with any of the following at the preoperative appointment: An ulcer of the skin, history of recurrent breakdown of the skin, use of steroids.\n* Patients in whom the Persona Revision Knee System is used as a temporary, interim, spacer-type, or destination-spacer construct are not eligible, including use in a 1.5-stage revision strategy or as the first-stage construct in a planned 2-stage revision. Enrollment is restricted to subjects in whom the Persona Revision Knee System is implanted as the surgeon-intended definitive revision knee arthroplasty following infection eradication.\n* Patient underwent contralateral total knee arthroplasty within 3 months of the planned index procedure or has a contralateral total knee arthroplasty planned within 3 months of the index procedure.\n* Patient is known to be pregnant or planning to become pregnant during the time they will be participating in the study.\n* Patient is a member of a vulnerable population group, such as\n\n  * A prisoner.\n  * A known alcohol or drug abuser.\n  * Mentally incompetent or unable to understand what participation in this study entails.\n* Patient with suspected or confirmed metal sensitivity or allergy to the metals of the device.","ALL","18 Years",{"count":19,"type":20},238,"ESTIMATED","OBSERVATIONAL","The purpose of this post-market clinical follow-up study is to confirm the long-term safety, performance and clinical benefits of the Persona Revision Knee System Implants and Instrumentation in revision Total Knee Arthroplasty.",[24,25,26],"Severe Knee Pain","Severe Knee Disability","Revision Arthroplasty","NOT_YET_RECRUITING","2026-09-21",{"date":30,"type":31},"2026-09-28","ACTUAL",{"date":33,"type":20},"2026-09",{"date":35,"type":20},"2038-12",{"name":37,"class":38},"Zimmer, GmbH","INDUSTRY",2,""]