[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657884":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":41,"studyPopulation":42,"armGroups":43,"interventions":37,"overallOfficials":50,"centralContacts":58,"locations":68,"responsibleParty":94,"collaborators":37,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":37,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":37,"enrollmentInfo":105,"targetDuration":37,"studyType":108,"phases":37,"briefSummary":109,"conditions":110,"keywords":37,"overallStatus":114,"whyStopped":37,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},{"fullName":5,"class":6},"Zimmer Biomet","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Oxford Knee Score (OKS) from Baseline to 2 Years","Average change in Oxford Knee Score (OKS) from baseline to 2 years follow-up. The average change will be evaluated against the Minimal Clinically Important Difference (MCID) of 4.0 points.","From baseline (pre-operative assessment) to 2 years after surgery",[14,18,22,26,29,33],{"measure":15,"description":16,"timeFrame":17},"All-Cause Implant Survival","All-cause survival of the implant system based on removal of any core system component (femoral component, tibial plate, or articular surface) for any reason","From surgery up to 10 years post-surgery",{"measure":19,"description":20,"timeFrame":21},"Adverse events \u002F Safety","Safety of the Persona Revision Knee System assessed by the frequency and incidence of adverse events, including the relationship of events to the implant, instrumentation, and\u002For surgical procedure.","From surgery up to 10 years of follow-up",{"measure":23,"description":24,"timeFrame":25},"Oxford Knee Score - follow-up beyond the primary endpoint","Oxford Knee Score to assess knee pain and functional performance during follow-up. The Oxford Knee Score ranges from 0 to 48, with higher scores indicating better outcomes.","Baseline, 3 months, 1 year, 2 years, 3 years (optional), 5 years, 7 years (optional), and 10 years post-surgery",{"measure":27,"description":28,"timeFrame":25},"EQ-5D-5L Health Related Quality of Life","EQ-5D-5L to assess subject health-related quality of life during follow-up.Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The descriptive system includes five dimensions: mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression. Each dimension is rated on a 5-level scale, from level 1 (no problems) to level 5 (extreme problems or inability), with higher levels indicating worse health status. The EQ visual analogue scale (EQ VAS) ranges from 0 to 100, with higher scores indicating better self-rated health.",{"measure":30,"description":31,"timeFrame":32},"Patient Satisfaction with the Study Knee and Treatment","Patient Satisfaction Questionnaire to assess patient satisfaction with the study knee and treatment. Patient satisfaction with the study knee and treatment will be assessed using the Patient Satisfaction Questionnaire. The questionnaire includes three questions: usual knee pain during the past 4 weeks, satisfaction with the knee replacement, and willingness to undergo the surgery again. Responses are categorical and will be summarized descriptively; no total questionnaire score will be calculated. Knee pain is rated as None, Very mild, Mild, Moderate, or Severe, with higher severity indicating worse outcome. Satisfaction is rated as Very satisfied, Satisfied, Neutral, Dissatisfied, or Very dissatisfied, with higher satisfaction indicating better outcome. Willingness to undergo surgery again is recorded as Yes or No.","3 months, 1 year, 2 years, 3 years (optional), 5 years, 7 years (optional), and 10 years post-surgery",{"measure":34,"description":35,"timeFrame":36},"Percentage (%) of Participants with significant radiographic findings","Presence or absence of significant radiographic findings will be assessed by standard-of-care radiographs. If a significant finding is identified, the type of finding is documented, including osteolysis, radiolucency, radiodensity, bone loss, subsidence, heterotopic ossification, fracture, implant loosening, articular surface wear, patellar dislocation, subluxation, tilt, or other significant findings. The amount of the finding may be recorded in millimeters (mm) or degrees, when applicable.","From baseline up to 10 years after surgery",null,{"allocation":37,"interventionModel":37,"interventionModelDescription":37,"primaryPurpose":37,"observationalModel":39,"timePerspective":40,"maskingInfo":37},"COHORT","PROSPECTIVE","Study Design:\n\nThis is a multicenter, Prospective, Non-controlled, Non-randomized, Consecutive series of patients, Dual cohort study.\n\nObjectives:\n\n* Confirm the long-term safety, performance and clinical benefits of the Persona Revision Knee System Implants and its Instrumentation when used in revision TKA.\n* Confirm that, under normal use, the performance and clinical benefits of this device and its instrumentation conform to those intended by the manufacturer by recording Patient-Reported clinical Outcome Measures (PROMs) and radiographic outcomes (if standard of care).\n\nCondition Being Treated\u002FTarget population:\n\nThe target population for this study consists of patients presenting with a clinically diagnosed necessity for revision total knee arthroplasty with severe knee pain or reduction in functionality resulting in the need for salvage of previously failed surgical attempts, or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery\n\nPer indication approved in the European Union and European Economic Area, only revision cases can be included in this study. 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\nEC Approval:\n\nThe study will require each site to obtain Ethics Committee approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.\n\nLength of Study:\n\n12 years including at least 2 years of enrollment and 10 years of follow up.\n\nSubjects must meet all the inclusion criteria and none of the exclusion criteria and receive the study device to participate in this study.\n\nStudy subjects will undergo preoperative clinical evaluations prior to their revision knee arthroplasty. The post-operative clinical and radiographic (if standard of care) evaluations will be conducted at 3 months, 1-year, 2-years, 3 -years, 5-years, 7-years and 10-years after implantation.\n\nData collection will de done in paper and electronic Case Report Forms (CRFs). CRFs will be completed either in-office or hospital at pre-operative, Surgery, Discharge, and the 3 months, 1-year, 2-year, and 5-year intervals. CRFs will be completed either in-office, by phone or by mail at the 3-year, 7-year, and 10-year intervals.\n\nThe PMCF is compliant with the following:\n\n* ISO 14155: 2020 - Clinical investigation of medical devices for human subjects - Good clinical practice\n* The Declaration of Helsinki (DoH) - Ethical principles for medical research involving human subjects\n* European Regulation (EU) 2017\u002F745\n* MDCG 2020-10\u002F1 Safety reporting in clinical investigations for medical devices under the Regulation (EU) 2017\u002F745\n\nFunding: Funding for this clinical study is made available by Zimmer Biomet to support clinical data collection, Ethic Committees review fees and other expenses associated with the conduct and execution of this study protocol","Patients undergoing revision total knee arthroplasty with the Persona Revision Knee System who meet the study eligibility criteria at participating study sites.",[44,47],{"label":45,"type":37,"description":46,"interventionNames":37},"Cohort 1: Persona Revision Knee + CCK articular surface","From the total sample size (238 cases), 119 cases will be implanted with the Persona Revision Knee and the CCK articular surface.",{"label":48,"type":37,"description":49,"interventionNames":37},"Cohort 2: Persona Revision Knee + CPS or PS articular surface","From the total sample size (238 cases), 119 cases will be implanted with the Persona Revision Knee and CPS or PS articular surface.",[51,55],{"name":52,"affiliation":53,"role":54},"Anders Troelsen, MD, PhD","Hvidovre University Hospital, Copenhagen, Denmark","PRINCIPAL_INVESTIGATOR",{"name":56,"affiliation":57,"role":54},"Fernando Martinez Delgado, MD, PhD","Hospital Universitario Miguel Servet, Zaragoza, Spain",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":37,"email":63},"Silvina Grasso, PhD","CONTACT","0034674348191","silvina.grasso@zimmerbiomet.com",{"name":65,"role":61,"phone":66,"phoneExt":37,"email":67},"Sabine Illi","0041792014430","sabine.Illi@zimmerbiomet.com",[69,82],{"facility":70,"status":37,"city":71,"state":37,"zip":37,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Hvidovre University Hospital","Copenhagen","Denmark","DK",{"type":75,"coordinates":76},"Point",[77,78],12.56553,55.67594,{"lat":78,"lon":77},[81],{"name":52,"role":61,"phone":37,"phoneExt":37,"email":37},{"facility":83,"status":37,"city":84,"state":37,"zip":37,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Hospital Miguel Servet","Zaragoza","Spain","ES",{"type":75,"coordinates":88},[89,90],-0.87734,41.65606,{"lat":90,"lon":89},[93],{"name":56,"role":61,"phone":37,"phoneExt":37,"email":37},{"type":95,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","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":106,"type":107},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.",[111,112,113],"Severe Knee Pain","Severe Knee Disability","Revision Arthroplasty","NOT_YET_RECRUITING","2026-09-21",{"date":117,"type":118},"2026-09-28","ACTUAL",{"date":120,"type":107},"2026-09",{"date":122,"type":107},"2038-12",{"name":124,"class":6},"Zimmer, GmbH",2]