[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100425529":3},{"organization":4,"armGroups":7,"interventions":52,"overallOfficials":58,"centralContacts":62,"locations":70,"responsibleParty":284,"collaborators":10,"id":286,"slug":287,"hasResults":288,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":10,"eligibilityCriteria":292,"healthyVolunteers":288,"sex":293,"minAge":294,"maxAge":10,"enrollmentInfo":295,"targetDuration":10,"studyType":298,"phases":10,"briefSummary":299,"conditions":300,"keywords":305,"overallStatus":73,"whyStopped":10,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":322},{"fullName":5,"class":6},"Zimmer Biomet","INDUSTRY",[8,14,18,22,26,30,34,38,42,46,49],{"label":9,"type":10,"description":11,"interventionNames":12},"1) Revision Splined CCK",null,"Patients who were implanted with a splined tibial stem, 0 degree Persona Revision tibial component, constrained condylar knee (CCK) articular surface, Persona Revision femoral component, and splined femoral stem.",[13],"Device: Persona Revision Knee System",{"label":15,"type":10,"description":16,"interventionNames":17},"2) Revision Cemented CCK","Patients who were implanted with a cemented tibial stem, 0 degree Persona Revision tibial component, CCK articular surface, Persona Revision femoral component, and cemented femoral stem.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"3) Revision Splined PS\u002FCPS","Patients who were implanted with a splined tibial stem, 0 degree Persona Revision tibial component, posterior stabilized\u002Fconstrained posterior stabilized (PS\u002FCPS) articular surface, Persona Revision femoral component, and splined femoral stem.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"4) Revision Cemented PS\u002FCPS","Patients who were implanted with a cemented tibial stem, 0 degree Persona Revision tibial component, PS\u002FCPS articular surface, Persona Revision femoral component, and cemented femoral stem.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"5) Revision Splined PS\u002FCPS","Patients who were implanted with a splined tibial stem, 0 degree Persona Revision tibial component, PS\u002FCPS articular surface, Persona primary PS femoral component, with no femoral stem.",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"6) Revision Cemented PS\u002FCPS","Patients who were implanted with a cemented tibial stem, 0 degree Persona Revision tibial component, PS\u002FCPS articular surface, Persona primary PS femoral component, with no femoral stem.",[13],{"label":35,"type":10,"description":36,"interventionNames":37},"7) Revision Cemented CCK with 5 Degree Primary Tibia","Patients who were implanted with a cemented tibial stem, 5 degree Persona primary tibial component, CCK articular surface, Persona Revision femoral component, and cemented femoral stem.",[13],{"label":39,"type":10,"description":40,"interventionNames":41},"8) Primary Splined CCK\u002FCPS\u002FPS with 0 Degree Tibia","Patients with a primary implant (non-revision case) who were implanted with a splined tibial stem, 0 degree Persona Revision tibial component, CCK\u002FPS\u002FCPS articular surface, Persona Revision femoral component, and splined femoral stem.",[13],{"label":43,"type":10,"description":44,"interventionNames":45},"9) Primary Cemented CCK\u002FPS\u002FCPS with 0 Degree Tibia","Patients with a primary implant (non-revision case) who were implanted with a cemented tibial stem, 0 degree Persona Revision tibial component, CCK\u002FPS\u002FCPS articular surface, Persona Revision femoral component, and cemented femoral stem.",[13],{"label":47,"type":10,"description":48,"interventionNames":10},"10) Primary Cemented CCK\u002FPS\u002FCPS with 5 Degree Primary Tibia","Patients with a primary implant (non-revision case) who were implanted with a cemented tibial stem, 5 degree Persona primary tibial component, CCK\u002FPS\u002FCPS articular surface, Persona Revision femoral component, and cemented femoral stem.",{"label":50,"type":10,"description":51,"interventionNames":10},"11) Infection Cases","Any configuration of PRK components used for end stage (non-temporary) treatment",[53],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":10},"DEVICE","Persona Revision Knee System","Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.",[9,15,19,23,27,31,35,39,43],[59],{"name":60,"affiliation":5,"role":61},"Charles Jaggard","STUDY_DIRECTOR",[63,68],{"name":64,"role":65,"phone":66,"phoneExt":10,"email":67},"Chelsea Smith","CONTACT","714-740-9438","chelsea.smith2@zimmerbiomet.com",{"name":60,"role":65,"phone":10,"phoneExt":10,"email":69},"charles.jaggard@zimmerbiomet.com",[71,93,109,120,131,141,161,171,188,198,208,218,235,254,264,274],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Advanced Orthopaedic Specialists","RECRUITING","Fayetteville","Arkansas","72703","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-94.15743,36.06258,{"lat":83,"lon":82},[86,90],{"name":87,"role":65,"phone":88,"phoneExt":10,"email":89},"Sydney Dale","479-316-4785","sdale@arkosm.com",{"name":91,"role":92,"phone":10,"phoneExt":10,"email":10},"Christopher Arnold, MD","PRINCIPAL_INVESTIGATOR",{"facility":94,"status":73,"city":95,"state":75,"zip":96,"country":77,"countryCode":78,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Bowen Hefley Orthopedics","Little Rock","72205",{"type":80,"coordinates":98},[99,100],-92.28959,34.74648,{"lat":100,"lon":99},[103,107],{"name":104,"role":65,"phone":105,"phoneExt":10,"email":106},"Jackie Ross","501-663-6455","jackie.ross@bowenhefleyortho.com",{"name":108,"role":92,"phone":10,"phoneExt":10,"email":10},"Paul Edwards, MD",{"facility":110,"status":111,"city":112,"state":113,"zip":114,"country":77,"countryCode":78,"cosmosGeoPoint":115,"geoPoint":119,"contacts":10},"Community Foundation Medical Group","WITHDRAWN","Fresno","California","93720",{"type":80,"coordinates":116},[117,118],-119.77237,36.74773,{"lat":118,"lon":117},{"facility":121,"status":122,"city":123,"state":124,"zip":125,"country":77,"countryCode":78,"cosmosGeoPoint":126,"geoPoint":130,"contacts":10},"Cornerstone Orthopaedics & Sports Medicine","COMPLETED","Superior","Colorado","80027",{"type":80,"coordinates":127},[128,129],-105.1686,39.95276,{"lat":129,"lon":128},{"facility":132,"status":122,"city":133,"state":134,"zip":135,"country":77,"countryCode":78,"cosmosGeoPoint":136,"geoPoint":140,"contacts":10},"Orthopaedic Associates, Inc.","Evansville","Indiana","47710",{"type":80,"coordinates":137},[138,139],-87.55585,37.97476,{"lat":139,"lon":138},{"facility":142,"status":73,"city":143,"state":134,"zip":144,"country":77,"countryCode":78,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Jeff Yergler, LLC","Granger","46530",{"type":80,"coordinates":146},[147,148],-86.11084,41.75338,{"lat":148,"lon":147},[151,155,159],{"name":152,"role":65,"phone":153,"phoneExt":10,"email":154},"Derek Yocum, PhD","865-360-9042","dyocum@sbortho.com",{"name":156,"role":65,"phone":157,"phoneExt":10,"email":158},"Emma Housholder","574-222-1822","ehousholder@sbortho.com",{"name":160,"role":92,"phone":10,"phoneExt":10,"email":10},"Jeffrey Yergler, MD",{"facility":162,"status":122,"city":163,"state":164,"zip":165,"country":77,"countryCode":78,"cosmosGeoPoint":166,"geoPoint":170,"contacts":10},"Arthroplasty Foundation Inc.","Louisville","Kentucky","40220",{"type":80,"coordinates":167},[168,169],-85.75941,38.25424,{"lat":169,"lon":168},{"facility":172,"status":73,"city":173,"state":174,"zip":175,"country":77,"countryCode":78,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Ascension Providence Rochester Hospital","Rochester","Michigan","48307",{"type":80,"coordinates":177},[178,179],-83.13382,42.68059,{"lat":179,"lon":178},[182,186],{"name":183,"role":65,"phone":184,"phoneExt":10,"email":185},"Kayla Chattinger","248-609-9137","kayla.chattinger@ascension.org",{"name":187,"role":92,"phone":10,"phoneExt":10,"email":10},"Nicholas Frisch, MD",{"facility":189,"status":190,"city":191,"state":174,"zip":192,"country":77,"countryCode":78,"cosmosGeoPoint":193,"geoPoint":197,"contacts":10},"Michigan Orthopaedic Surgeons, PLLC","ACTIVE_NOT_RECRUITING","Southfield","48076",{"type":80,"coordinates":194},[195,196],-83.22187,42.47337,{"lat":196,"lon":195},{"facility":199,"status":122,"city":200,"state":201,"zip":202,"country":77,"countryCode":78,"cosmosGeoPoint":203,"geoPoint":207,"contacts":10},"TRIA Orthopaedic Center Research Institute","Bloomington","Minnesota","55431",{"type":80,"coordinates":204},[205,206],-93.29828,44.8408,{"lat":206,"lon":205},{"facility":209,"status":111,"city":210,"state":211,"zip":212,"country":77,"countryCode":78,"cosmosGeoPoint":213,"geoPoint":217,"contacts":10},"Thomas Aleto MD, PC","Columbia","Missouri","65201",{"type":80,"coordinates":214},[215,216],-92.33407,38.95171,{"lat":216,"lon":215},{"facility":219,"status":73,"city":220,"state":221,"zip":222,"country":77,"countryCode":78,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Orthopaedic Research Institute of New Jersey","Chester","New Jersey","07390",{"type":80,"coordinates":224},[225,226],-74.69683,40.78427,{"lat":226,"lon":225},[229,233],{"name":230,"role":65,"phone":231,"phoneExt":10,"email":232},"Melissa Hough","908-684-3005","mhough@orthopedicnj.com",{"name":234,"role":92,"phone":10,"phoneExt":10,"email":10},"John Dundon, MD",{"facility":236,"status":73,"city":237,"state":238,"zip":239,"country":77,"countryCode":78,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"The Cleveland Clinic Foundation","Cleveland","Ohio","44195",{"type":80,"coordinates":241},[242,243],-81.69541,41.4995,{"lat":243,"lon":242},[246,249,252],{"name":247,"role":65,"phone":10,"phoneExt":10,"email":248},"Alison Klika","klikaa@ccf.org",{"name":250,"role":65,"phone":10,"phoneExt":10,"email":251},"Anabelle Visperas","vispera@ccf.org",{"name":253,"role":92,"phone":10,"phoneExt":10,"email":10},"Michael Bloomfield, MD",{"facility":255,"status":122,"city":256,"state":257,"zip":258,"country":77,"countryCode":78,"cosmosGeoPoint":259,"geoPoint":263,"contacts":10},"ROC Orthopedics","Oregon City","Oregon","97045",{"type":80,"coordinates":260},[261,262],-122.60676,45.35734,{"lat":262,"lon":261},{"facility":265,"status":122,"city":266,"state":267,"zip":268,"country":77,"countryCode":78,"cosmosGeoPoint":269,"geoPoint":273,"contacts":10},"Penn Medicine\u002F Lancaster General Health","Lancaster","Pennsylvania","17602",{"type":80,"coordinates":270},[271,272],-76.30551,40.03788,{"lat":272,"lon":271},{"facility":275,"status":111,"city":276,"state":277,"zip":278,"country":77,"countryCode":78,"cosmosGeoPoint":279,"geoPoint":283,"contacts":10},"Orthopedic Surgeons of Wisconsin, SC","Wauwatosa","Wisconsin","53222",{"type":80,"coordinates":280},[281,282],-88.00759,43.04946,{"lat":282,"lon":281},{"type":285,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100425529","persona-revision-knee-system-outcomes-100425529",false,"NCT04821154","Persona Revision Knee System Outcomes","Clinical Investigation to Demonstrate Performance, Safety and Clinical Benefits of the Persona Revision Knee System","Inclusion Criteria:\n\n1. Male or female of at least 18 years of age at the time of screening.\n2. Signed an institutional review board approved informed consent.\n3. Willingness and ability to comply with the study procedures and visit schedules and ability to understand and follow oral and written post-operative care instructions.\n4. Previous medical diagnosis\u002F history of at least one of the following conditions requiring treatment using the Persona Revision Knee System within a pre-specified study variant configuration (cohort), in accordance with the instructions for use (IFU):\n\n   1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis or polyarthritis\n   2. Collagen disorders, and\u002For avascular necrosis of the femoral condyle\n   3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy\n   4. Moderate valgus, varus, or flexion deformities\n   5. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery\n5. A pre-operative Knee Society Knee Score (objective assessment) ≤ 80.\n\nExclusion Criteria:\n\n1\\) Presence of clinically observed active or suspected latent infection in the affected joint at the time of procedure.\n\n3\\) Presence of of local\u002Fsystemic\u002Fdistant focal infection that may affect or hematogenously spread to the prosthetic joint.\n\n4\\) Skeletal immaturity or insufficient bone stock on femoral or tibial surfaces which cannot provide adequate support and\u002For fixation to the prosthesis.\n\n5\\) Diagnosed with neuropathic arthropathy, osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb.\n\n6\\) Presence of a stable, painless arthrodesis in a satisfactory functional position in the affected joint.\n\n7\\) Severe instability of the affected joint secondary to the absence of collateral ligament integrity.\n\n8\\) Diagnosis of rheumatoid arthritis in conjunction with any of the following at the time of screening:\n\n1. An ulcer of the skin\n2. History of recurrent breakdown of the skin\n3. Use of steroids\n\n   9\\) Patient requires simultaneous bilateral knee surgery for treatment of diagnosed condition.\n\n   10\\) Pregnant or women planning to become pregnant during the time they will be participating in the study.\n\n   11\\) Any documented clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening which, in the opinion of the Investigator, could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study procedure.\n\n   12\\) Any patient who is institutionalized, or with a known drug or alcohol dependence currently or within the last year.","ALL","18 Years",{"count":296,"type":297},380,"ESTIMATED","OBSERVATIONAL","The study will evaluate the performance, clinical benefits and safety of the Persona Revision Knee System in patients who have received primary or revision total knee arthroplasty (TKA) treatment. This will be done using a multicenter, single-arm, consecutive series, retrospective cohort study with prospective follow-up.",[301,302,303,304],"Arthroplasty Complications","Infection","Knee Disease","Knee Osteoarthritis",[306,307,308,309,310,311,312],"Revision","Total Knee","Medical Device","Safety","Performance","Primary","Clinical Benefits","2025-10-22",{"date":315,"type":316},"2025-10-24","ACTUAL",{"date":318,"type":316},"2021-06-14",{"date":320,"type":297},"2027-12-31",{"name":5,"class":6},16]