[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100310997":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":18,"responsibleParty":37,"collaborators":10,"id":40,"slug":10,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":10,"enrollmentInfo":48,"targetDuration":10,"studyType":51,"phases":10,"briefSummary":52,"conditions":53,"keywords":10,"overallStatus":21,"whyStopped":10,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},{"fullName":5,"class":6},"Vanderbilt University Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Proximal Humerus Fracture Patients",null,"As part of their routine care, patients who have experienced a proximal humerus fracture that requires operative fixation will receive the A.L.P.S® Proximal Humerus Plating System. This study is an observational, prospective study that monitors the patient's pain, functional ability, and patient-reported outcomes.",[13],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Julie M Daniels","CONTACT","615-322-4506","Julie.M.Daniels@Vanderbilt.edu",[19],{"facility":20,"status":21,"city":22,"state":23,"zip":24,"country":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"Vanderbilt Orthopaedics","RECRUITING","Nashville","Tennessee","37232","United States",{"type":27,"coordinates":28},"Point",[29,30],-86.78444,36.16589,{"lat":30,"lon":29},[33,34],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},{"name":35,"role":36,"phone":10,"phoneExt":10,"email":10},"Mihir J Desai, MD","PRINCIPAL_INVESTIGATOR",{"type":36,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Mihir Desai","Assistant Professor of Orthopaedic Surgery and Rehabilitation","100310997",false,"NCT03328650","Clinical Outcomes of the ALPS Proximal Humerus Plating System","ALPS PHP","Inclusion Criteria:\n\n* Patients who present with a proximal humerus fracture requiring primary or revision ORIF using A.L.P.S Proximal Humerus Plating System\n* Patients who present with a proximal humerus fracture that involves the metaphysis\n* 18 years or older\n\nExclusion Criteria:\n\n* Patients under the age of 18\n* Patients who have an infection, sepsis, or osteomyelitis\n* Patients who are unwilling to take part in study, have documented psychiatric disorder that limits ability to consent and maintain follow-up, or who may have severe problems maintaining follow-up (e.g. patients who are prisoners, homeless, intellectually changed without adequate family support)\n* Patients who do not speak English (do to unavailability of non-English surveys)\n* Patients who have known risk factors of pathologic fractures (e.g. bone metastasis)\n* Patients who have received treatment for osteoporosis (e.g. bisphosphonate) within the last 5 years or whose treatment lasted longer than 5 years\n* Patients who have Type 1 diabetes\n* Patients who have other bone disease (e.g. osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism)\n* Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use","ALL","18 Years",{"count":49,"type":50},150,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System.\n\nSpecific Aims:\n\n* Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs\n* Obtain patient-reported outcomes regarding pain level, function capabilities, and work\u002Fleisure restrictions\n* Document revisions, complications, and adverse events",[54],"Proximal Humeral Fracture","2026-05-05",{"date":57,"type":58},"2026-05-11","ACTUAL",{"date":60,"type":58},"2017-08-07",{"date":62,"type":50},"2031-12-01",{"name":5,"class":6},1]