[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625331":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":10,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":10,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":10,"overallStatus":76,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Zimmer Biomet","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"OsseoFit Stemless Inlay",null,"Subjects who were implanted with the Inlay variant of the Osseofit Stemless Shoulder System.",[13],"Device: OsseoFit Stemless Inlay",{"label":15,"type":10,"description":16,"interventionNames":17},"OsseoFit Stemless Onlay","Subjects who were implanted with the Onlay variant of the Osseofit Stemless Shoulder System.",[18],"Device: OsseoFit Stemless Onlay",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","Inlay implants have a dished superior portion with a shorter fin length to allow the implant to sit within the bone.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":10},"The Onlay implants sit on top of the prepared bone.",[15],[28],{"name":29,"affiliation":5,"role":30},"Jim Nevelos","STUDY_DIRECTOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"Octavia Gladden","CONTACT","(704) 493-0178","octavia.gladden@zimmerbiomet.com",{"name":38,"role":34,"phone":10,"phoneExt":10,"email":39},"Ryan Boylan","Ryan.Boylan@zimmerbiomet.com",[41],{"facility":42,"status":10,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":10},"The Research Foundation for the State University of New York","Buffalo","New York","14228","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-78.87837,42.88645,{"lat":52,"lon":51},{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100625331","osseofit-stemless-shoulder-system-anatomic-100625331",false,"NCT07421245","OsseoFit Stemless Shoulder System (Anatomic)","OsseoFit Stemless Shoulder System (Anatomic) Post-Market Clinical Follow-up Study","Inclusion Criteria:\n\n* Patient must be 20 years of age or older.\n* The patient must be anatomically and structurally suited, as evident by scapula and proximal humerus closure, to receive the implants.\n* Patient planned to receive OsseoFit™ anchor with uncemented fixation.\n* Patient planned to receive a Modular Alliance Glenoid with bone cement. The porous posts must be coated with Porous Plasma Spray (PPS) and may be inserted without bone cement.\n* Patient planned to receive shoulder arthroplasty due to osteoarthritis.\n* Patient must be able and willing to complete the protocol required follow-up schedule.\n* Patient must be able and willing to sign the IRB approved consent.\n\nExclusion Criteria:\n\n* Patient is unwilling or unable to give consent or to comply with the follow-up program.\n* Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.\n* Patient is known to be pregnant or breastfeeding.\n* Patient is a vulnerable participant (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and\u002For anticipated to be non-compliant).\n* Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.\n* Patient has any neuromuscular disease compromising the affected limb.\n* Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site. This may include:\n\n  * Local\u002Fsystemic infection\n  * Sepsis\n  * Osteomyelitis\n* Patient presents with Osteomalacia.\n* Patient presents with a humeral bone fracture.\n* Patient presents with malunion or non-union of the tuberosities of the proximal humerus.\n* Patient has had a previous operative shoulder prosthesis (stem or stemless).\n* Patient has irreparable cuff tear.\n* Patient presents with inadequate humeral bone, which in the opinion of the Investigator, may lead to poor implant fixation. This may include but is not limited to:\n\n  * Osteoporosis\n  * Extensive Avascular Necrosis\n  * Rheumatoid Arthritis\n  * Metaphyseal bony defects (including large cysts)","ALL","20 Years",{"count":66,"type":67},136,"ESTIMATED","OBSERVATIONAL","The purpose of this clinical research protocol is to evaluate the safety, efficacy, and long-term outcomes of the OsseoFit Stemless Shoulder System (Anatomic) in patients with a primary diagnosis of osteoarthritis. The study aims to assess the intraoperative characteristics, postoperative complications, functional outcomes, and radiographic findings associated with the use of the stemless implant system. Ultimately, this research aims to improve patient outcomes, enhance surgical techniques, and inform clinical decision-making in the treatment of shoulder pathology.",[71,72,73,74,75],"Shoulder Injuries","Shoulder Pain","Shoulder Fractures","Shoulder Arthritis","Shoulder Disease","NOT_YET_RECRUITING","2026-04-22",{"date":79,"type":80},"2026-04-23","ACTUAL",{"date":82,"type":67},"2026-04",{"date":84,"type":67},"2036-01",{"name":5,"class":6},1]