[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576701":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":68,"collaborators":10,"id":70,"slug":10,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":10,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":10,"studyType":82,"phases":10,"briefSummary":83,"conditions":84,"keywords":10,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"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",[31,51],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Cedars Sinai Medical Center","RECRUITING","Los Angeles","California","900033","United States",{"type":39,"coordinates":40},"Point",[41,42],-118.24368,34.05223,{"lat":42,"lon":41},[45,48],{"name":46,"role":27,"phone":10,"phoneExt":10,"email":47},"Ali Zafar","Ali.Zafar-Khan@cskerlanjobe.org",{"name":49,"role":50,"phone":10,"phoneExt":10,"email":10},"John Itamura, MD","PRINCIPAL_INVESTIGATOR",{"facility":52,"status":33,"city":53,"state":10,"zip":54,"country":55,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Aalborg University Hospital","Aalborg","DK-9000","Denmark",{"type":39,"coordinates":57},[58,59],9.9187,57.048,{"lat":59,"lon":58},[62,66],{"name":63,"role":27,"phone":64,"phoneExt":10,"email":65},"Julie Nicoux","+33 06 72 61 35 02","julie.nicoux@zimmerbiomet.com",{"name":67,"role":50,"phone":10,"phoneExt":10,"email":10},"SteenLund Jensen, MD",{"type":69,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":80,"type":81},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.",[85,86,87,88,89],"Shoulder Pain","Shoulder Injuries","Shoulder Fractures","Shoulder Disease","Shoulder Arthritis","2026-04-22",{"date":92,"type":93},"2026-04-28","ACTUAL",{"date":95,"type":93},"2025-06-19",{"date":97,"type":81},"2040-12",{"name":5,"class":6},2]