[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100420387":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":173,"collaborators":20,"id":175,"slug":20,"hasResults":176,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":20,"eligibilityCriteria":180,"healthyVolunteers":181,"sex":182,"minAge":183,"maxAge":20,"enrollmentInfo":184,"targetDuration":20,"studyType":187,"phases":188,"briefSummary":190,"conditions":191,"keywords":20,"overallStatus":100,"whyStopped":20,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":209},{"fullName":5,"class":6},"Zimmer Biomet","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"G7 Shell with Vivacit-E and Longevity Highly Crosslinked Polyethylene Liners","OTHER","Up to 300 hips globally will be implanted with a G7 Shell and either the Vivacit-E or Longevity Liner. The liner used by each site will be identified at start-up.",[13],"Device: Vivacit-E and Longevity (HXLPE) Liners",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Vivacit-E and Longevity (HXLPE) Liners","This is a dual cohort study in which 150 subjects will receive the Vivacit-E (HXLPE) Liner and 150 subjects will receive the Longevity (HXLPE) Liner.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Hillary Overholser","STUDY_DIRECTOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Wendy J Hatcher","CONTACT","574-549-4281","wendy.hatcher@zimmerbiomet.com",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Lynsey Boyle","412-552-7111","lynsey.boyle@zimmerbiomet.com",[36,49,59,69,79,88,98,116,126,140,155],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":20},"Colorado Joint Replacement","ACTIVE_NOT_RECRUITING","Denver","Colorado","80210","United States",{"type":44,"coordinates":45},"Point",[46,47],-104.9847,39.73915,{"lat":47,"lon":46},{"facility":50,"status":38,"city":51,"state":52,"zip":53,"country":42,"cosmosGeoPoint":54,"geoPoint":58,"contacts":20},"South Bend Orthopaedics","South Bend","Indiana","46635",{"type":44,"coordinates":55},[56,57],-86.25001,41.68338,{"lat":57,"lon":56},{"facility":60,"status":38,"city":61,"state":62,"zip":63,"country":42,"cosmosGeoPoint":64,"geoPoint":68,"contacts":20},"Duke University Medical Center","Durham","North Carolina","27703",{"type":44,"coordinates":65},[66,67],-78.89862,35.99403,{"lat":67,"lon":66},{"facility":70,"status":38,"city":71,"state":72,"zip":73,"country":42,"cosmosGeoPoint":74,"geoPoint":78,"contacts":20},"Slocum Center for Orthopedics & Sports Medicine","Eugene","Oregon","97401",{"type":44,"coordinates":75},[76,77],-123.08675,44.05207,{"lat":77,"lon":76},{"facility":80,"status":38,"city":81,"state":72,"zip":82,"country":42,"cosmosGeoPoint":83,"geoPoint":87,"contacts":20},"Oregon Health and Science University","Portland","97239",{"type":44,"coordinates":84},[85,86],-122.67621,45.52345,{"lat":86,"lon":85},{"facility":89,"status":38,"city":90,"state":91,"zip":92,"country":42,"cosmosGeoPoint":93,"geoPoint":97,"contacts":20},"University of Utah Health","Salt Lake City","Utah","84112",{"type":44,"coordinates":94},[95,96],-111.89105,40.76078,{"lat":96,"lon":95},{"facility":99,"status":100,"city":101,"state":20,"zip":102,"country":103,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Copenhagen University Hospital Hvidovre","RECRUITING","Hvidovre","2650","Denmark",{"type":44,"coordinates":105},[106,107],12.47708,55.64297,{"lat":107,"lon":106},[110,114],{"name":111,"role":28,"phone":112,"phoneExt":20,"email":113},"Anders Troelsen, MD, PhD","+45 27 337008","Anders.Troelsen@regionh.dk",{"name":111,"role":115,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"facility":117,"status":38,"city":118,"state":20,"zip":119,"country":120,"cosmosGeoPoint":121,"geoPoint":125,"contacts":20},"Zuyderland Hospital","Geleen","6162 BG","Netherlands",{"type":44,"coordinates":122},[123,124],5.82917,50.97417,{"lat":124,"lon":123},{"facility":127,"status":100,"city":128,"state":20,"zip":20,"country":120,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"OCON Hengelo","Hengelo",{"type":44,"coordinates":130},[131,132],6.79306,52.26583,{"lat":132,"lon":131},[135,139],{"name":136,"role":28,"phone":137,"phoneExt":20,"email":138},"Dean Pakvis, MD","+46 70 4604525","d.pakvis@ocon.nl",{"name":136,"role":115,"phone":20,"phoneExt":20,"email":20},{"facility":141,"status":100,"city":142,"state":20,"zip":143,"country":144,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Skane University Hospital","Lund","221 85","Sweden",{"type":44,"coordinates":146},[147,148],13.19321,55.70584,{"lat":148,"lon":147},[151,154],{"name":152,"role":28,"phone":137,"phoneExt":20,"email":153},"Uldis Kesteris, MD","uldis.kesteris@med.lu.se",{"name":152,"role":115,"phone":20,"phoneExt":20,"email":20},{"facility":156,"status":100,"city":157,"state":158,"zip":159,"country":160,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital","Bournemouth","UK","BH7 7DW","United Kingdom",{"type":44,"coordinates":162},[163,164],-1.8795,50.72048,{"lat":164,"lon":163},[167,171],{"name":168,"role":28,"phone":169,"phoneExt":20,"email":170},"Robert Middelton, MD, PhD","+44 01202 303477","robert.middleton@rbch.nhs.uk",{"name":172,"role":115,"phone":20,"phoneExt":20,"email":20},"Robert Middleton, MD, PhD",{"type":174,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100420387",false,"NCT04754087","G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study","Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the G7 Acetabular System With Vivacit-E and Longevity Highly Crosslinked Polyethylene (HXLPE) Liners & Instrumentation","Inclusion Criteria:\n\n* Patient must be a legal adult who has reached full skeletal maturity.\n* Patient must be treated for one of the following indications:\n* Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis\n* Rheumatoid arthritis\n* Correction of functional deformity\n* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques\n* Revision procedures where other treatment or devices have failed\n* Patient must be able and willing to complete the protocol required follow-up visits.\n* Patient must be able and willing to sign the Institutional Review Board or Ethics Committee (IRB\u002FEC) approved informed consent.\n\nExclusion Criteria:\n\n* Patient presents with osteoporosis, which in the opinion of the Principal Investigator, may limit the subject's ability to support total hip arthroplasty using the study device.\n* Patient has a metabolic disorder that may impair bone formation.\n* Patient has osteomalacia.\n* Patient has distant foci of infections which may spread to the implant site or patient with infection, sepsis or osteomyelitis.\n* Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.\n* Patient has a vascular insufficiency, muscular atrophy, or neuromuscular disease\n* Patient is a prisoner.\n* Patient is a current alcohol or drug abuser.\n* Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.\n* Patient is pregnant.",true,"ALL","18 Years",{"count":185,"type":186},300,"ESTIMATED","INTERVENTIONAL",[189],"NA","The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and revision total hip arthroplasty.",[192,193,194,195,196,197,198,199],"Total Hip Arthroplasty","Degenerative Joint Disease of Hip","Avascular Necrosis of Hip","Rheumatoid Arthritis of Hip","Osteoarthritis, Hip","Osteoarthritis of Hip","Fractures, Hip","Fracture of Hip","2025-06-13",{"date":202,"type":203},"2025-06-18","ACTUAL",{"date":205,"type":203},"2021-07-07",{"date":207,"type":186},"2033-12-31",{"name":5,"class":6},11]