[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100420387":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":177,"collaborators":20,"id":179,"slug":180,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":20,"eligibilityCriteria":185,"healthyVolunteers":186,"sex":187,"minAge":188,"maxAge":20,"enrollmentInfo":189,"targetDuration":20,"studyType":192,"phases":193,"briefSummary":195,"conditions":196,"keywords":20,"overallStatus":101,"whyStopped":20,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},{"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",[36,50,60,70,80,89,99,118,129,143,159],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":20},"Colorado Joint Replacement","ACTIVE_NOT_RECRUITING","Denver","Colorado","80210","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-104.9847,39.73915,{"lat":48,"lon":47},{"facility":51,"status":38,"city":52,"state":53,"zip":54,"country":42,"countryCode":43,"cosmosGeoPoint":55,"geoPoint":59,"contacts":20},"South Bend Orthopaedics","South Bend","Indiana","46635",{"type":45,"coordinates":56},[57,58],-86.25001,41.68338,{"lat":58,"lon":57},{"facility":61,"status":38,"city":62,"state":63,"zip":64,"country":42,"countryCode":43,"cosmosGeoPoint":65,"geoPoint":69,"contacts":20},"Duke University Medical Center","Durham","North Carolina","27703",{"type":45,"coordinates":66},[67,68],-78.89862,35.99403,{"lat":68,"lon":67},{"facility":71,"status":38,"city":72,"state":73,"zip":74,"country":42,"countryCode":43,"cosmosGeoPoint":75,"geoPoint":79,"contacts":20},"Slocum Center for Orthopedics & Sports Medicine","Eugene","Oregon","97401",{"type":45,"coordinates":76},[77,78],-123.08675,44.05207,{"lat":78,"lon":77},{"facility":81,"status":38,"city":82,"state":73,"zip":83,"country":42,"countryCode":43,"cosmosGeoPoint":84,"geoPoint":88,"contacts":20},"Oregon Health and Science University","Portland","97239",{"type":45,"coordinates":85},[86,87],-122.67621,45.52345,{"lat":87,"lon":86},{"facility":90,"status":38,"city":91,"state":92,"zip":93,"country":42,"countryCode":43,"cosmosGeoPoint":94,"geoPoint":98,"contacts":20},"University of Utah Health","Salt Lake City","Utah","84112",{"type":45,"coordinates":95},[96,97],-111.89105,40.76078,{"lat":97,"lon":96},{"facility":100,"status":101,"city":102,"state":20,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Copenhagen University Hospital Hvidovre","RECRUITING","Hvidovre","2650","Denmark","DK",{"type":45,"coordinates":107},[108,109],12.47708,55.64297,{"lat":109,"lon":108},[112,116],{"name":113,"role":28,"phone":114,"phoneExt":20,"email":115},"Anders Troelsen, MD, PhD","+45 27 337008","Anders.Troelsen@regionh.dk",{"name":113,"role":117,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"facility":119,"status":38,"city":120,"state":20,"zip":121,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":128,"contacts":20},"Zuyderland Hospital","Geleen","6162 BG","Netherlands","NL",{"type":45,"coordinates":125},[126,127],5.82917,50.97417,{"lat":127,"lon":126},{"facility":130,"status":101,"city":131,"state":20,"zip":20,"country":122,"countryCode":123,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"OCON Hengelo","Hengelo",{"type":45,"coordinates":133},[134,135],6.79306,52.26583,{"lat":135,"lon":134},[138,142],{"name":139,"role":28,"phone":140,"phoneExt":20,"email":141},"Dean Pakvis, MD","+46 70 4604525","d.pakvis@ocon.nl",{"name":139,"role":117,"phone":20,"phoneExt":20,"email":20},{"facility":144,"status":101,"city":145,"state":20,"zip":146,"country":147,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Skane University Hospital","Lund","221 85","Sweden","SE",{"type":45,"coordinates":150},[151,152],13.19321,55.70584,{"lat":152,"lon":151},[155,158],{"name":156,"role":28,"phone":140,"phoneExt":20,"email":157},"Uldis Kesteris, MD","uldis.kesteris@med.lu.se",{"name":156,"role":117,"phone":20,"phoneExt":20,"email":20},{"facility":160,"status":101,"city":161,"state":162,"zip":163,"country":164,"countryCode":162,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital","Bournemouth","UK","BH7 7DW","United Kingdom",{"type":45,"coordinates":166},[167,168],-1.8795,50.72048,{"lat":168,"lon":167},[171,175],{"name":172,"role":28,"phone":173,"phoneExt":20,"email":174},"Robert Middelton, MD, PhD","+44 01202 303477","robert.middleton@rbch.nhs.uk",{"name":176,"role":117,"phone":20,"phoneExt":20,"email":20},"Robert Middleton, MD, PhD",{"type":178,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100420387","g7-acetabular-system-with-vivacit-e-or-longevity-liner-pmcf-study-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":190,"type":191},300,"ESTIMATED","INTERVENTIONAL",[194],"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.",[197,198,199,200,201,202,203,204],"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":207,"type":208},"2025-06-18","ACTUAL",{"date":210,"type":208},"2021-07-07",{"date":212,"type":191},"2033-12-31",{"name":5,"class":6},11]