[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576701":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":70,"collaborators":10,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":10,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":10,"studyType":85,"phases":10,"briefSummary":86,"conditions":87,"keywords":10,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Zimmer Biomet","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group",null,"The study population will comprise a consecutive cohort of 59 cases (males and females), implanted with the Comprehensive Primary Revision Stem.",[13],"Device: Comprehensive Primary Revision Stems",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Comprehensive Primary Revision Stems","Comprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty.",[9],[21],{"name":22,"affiliation":5,"role":23},"Ryan Boylan, MBA","STUDY_DIRECTOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Octavia Gladden","CONTACT","7044930178","octavia.gladden@zimmerbiomet.com",[31,52],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Cedars Sinai Medical Center","RECRUITING","Los Angeles","California","900033","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-118.24368,34.05223,{"lat":43,"lon":42},[46,49],{"name":47,"role":27,"phone":10,"phoneExt":10,"email":48},"Ali Zafar","Ali.Zafar-Khan@cskerlanjobe.org",{"name":50,"role":51,"phone":10,"phoneExt":10,"email":10},"John Itamura, MD","PRINCIPAL_INVESTIGATOR",{"facility":53,"status":33,"city":54,"state":10,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Aalborg University Hospital","Aalborg","DK-9000","Denmark","DK",{"type":40,"coordinates":59},[60,61],9.9187,57.048,{"lat":61,"lon":60},[64,68],{"name":65,"role":27,"phone":66,"phoneExt":10,"email":67},"Julie Nicoux","+33 06 72 61 35 02","julie.nicoux@zimmerbiomet.com",{"name":69,"role":51,"phone":10,"phoneExt":10,"email":10},"SteenLund Jensen, MD",{"type":71,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100576701","mdr---comprehensive-primary-revision-stems-pmcf-100576701",false,"NCT06788717","MDR - Comprehensive Primary Revision Stems PMCF","Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive® Primary Revision Stems (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study","Inclusion Criteria\n\n* Patient must be 18 years of age or older.\n* Patient must be willing and able to follow directions.\n* Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Revision Stem\n\nExclusion Criteria\n\n* Off-label use.\n* Patient is a prisoner.\n* Patient is a current alcohol or drug abuser.\n* Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.\n* Patient is unwilling to sign informed consent.\n* Uncooperative patient or patient with neurologic disorders who are incapable of following directions.","ALL","18 Years","100 Years",{"count":83,"type":84},59,"ESTIMATED","OBSERVATIONAL","The objective of this retrospective and prospective consecutive series PMCF (Post Market Clinical Follow Up) study is to collect long-term data confirming safety, performance and clinical benefits of the Comprehensive Primary Revision Stems (implants and instrumentation) when used for shoulder arthroplasty at 1, 3, 5, 7 and 10 years.",[88,89,90,91,92],"Shoulder Pain","Shoulder Injuries","Shoulder Fractures","Shoulder Disease","Shoulder Arthritis","2026-04-22",{"date":95,"type":96},"2026-04-28","ACTUAL",{"date":98,"type":96},"2025-06-19",{"date":100,"type":84},"2040-12",{"name":5,"class":6},2]