[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564324":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":35,"responsibleParty":67,"collaborators":10,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":10,"eligibilityCriteria":74,"healthyVolunteers":71,"sex":75,"minAge":76,"maxAge":10,"enrollmentInfo":77,"targetDuration":80,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Maxx Orthopedics Inc","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients receiving the Maxx Freedom Total Knee System for primary TKA",null,"TARGETED PATIENTS Adult male and female patients greater than 18 years of age Candidate for primary TKA GENERAL EXCLUSIONS Active infection Revision \u002F conversion TKA (Prior UKA or HTO)",[13],"Device: Total Knee Arthroplasty",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Total Knee Arthroplasty","Post-Market Surveillance of the Freedom Total Knee System for Primary TKA",[9],[21],{"name":22,"affiliation":23,"role":24},"Asit Shah, MD, PhD","Chief of Orthopedics, Englewood Hospital","STUDY_CHAIR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Nach Dave, MS, RPh","CONTACT","732-718-1385","nach.dave@maxxortho.com",{"name":32,"role":28,"phone":33,"phoneExt":10,"email":34},"Corey Perine, BS, MBA","215-432-4323","corey.perine@maxxortho.com",[36,54],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Ascentist Healthcare","RECRUITING","Leawood","Kansas","66211","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-94.6169,38.96667,{"lat":48,"lon":47},[51],{"name":52,"role":53,"phone":10,"phoneExt":10,"email":10},"Andrew C Palmoisano, MD","PRINCIPAL_INVESTIGATOR",{"facility":55,"status":38,"city":56,"state":57,"zip":58,"country":42,"countryCode":43,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"South Texas Bone & Joint Institute","San Antonio","Texas","78249",{"type":45,"coordinates":60},[61,62],-98.49363,29.42412,{"lat":62,"lon":61},[65],{"name":66,"role":53,"phone":10,"phoneExt":10,"email":10},"Siraj A Sayeed, MD",{"type":68,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100564324","prospective-in-vivo-post-market-safety-and-efficacy-surveillance-registry-of-the-maxx-orthopedics-freedom-total-knee-system-100564324",false,"NCT06627699","Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® System","INCLUSION CRITERIA:\n\nCandidates for this registry must meet ALL of the following criteria:\n\n* Patient is \\> 18 years of age\n* Patient has failed attempts at non-operative conservative therapy\n* Patient has participated in the informed consent process and signed an IRB approved informed consent\n* Patient is scheduled to undergo unilateral or bilateral primary TKA of the knee\n\nEXCLUSION CRITERIA:\n\nCandidates will be excluded from the evaluation if ANY of the following apply:\n\n* Patients with previous TKA, UKA, HTO or knee fusion of the indicated knee\n* Patients that have undergone previous surgery of indicated knee for tumor, trauma or fracture\n* Evidence of active or suspected (systemic or local) infection at time of surgery\n* Other significant disabling problems from the musculoskeletal system than in the knee (i.e.: muscular dystrophy, polio, neuropathic joints)\n* Patients with or having; malignancy - active malignancy, Paget's disease, renal osteodystrophy, immunologically suppressed, sickle cell anemia and systemic lupus erythematosus\n* Patients with neuromuscular or neurosensory deficit\n* Women who are pregnant\n* Prisoner or transient\n* Recent history of known narcotic abuse\n* Any significant psychological disturbance past or present, that could impair the consent process or ability to complete subject self-report questionnaires","ALL","18 Years",{"count":78,"type":79},300,"ESTIMATED","2 Years","OBSERVATIONAL","In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring.",[84,85],"Knee Osteoarthristis","Total Knee Anthroplasty",[87,88,17,89],"Registry","Primary TKA","Total Knee Replacement","2026-06-23",{"date":92,"type":93},"2026-06-26","ACTUAL",{"date":95,"type":93},"2025-11-01",{"date":97,"type":79},"2029-03-01",{"name":5,"class":6},2]