[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467272":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":29,"responsibleParty":146,"collaborators":10,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":10,"eligibilityCriteria":153,"healthyVolunteers":150,"sex":154,"minAge":155,"maxAge":10,"enrollmentInfo":156,"targetDuration":10,"studyType":159,"phases":10,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"Paragon 28","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"50 Subjects",null,"50 Subjects Receiving the Patient Specific Talus Spacer.",[13],"Device: Patient Specific Talus Spacer",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Patient Specific Talus Spacer","Patient Specific Talus Spacer is a solid polished replica of the patient's bone.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Jacy Legue","CONTACT","720-399-3400","jlegue@paragon28.com",{"name":27,"role":23,"phone":24,"phoneExt":10,"email":28},"Caleigh Bates","cbates@paragon28.com",[30,51,67,90,111,129],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Redwood Orthopaedics","RECRUITING","Santa Rosa","California","95403","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-122.71443,38.44047,{"lat":42,"lon":41},[45,48],{"name":46,"role":23,"phone":47,"phoneExt":10,"email":10},"Thomas Chang, DPM","707-544-3400",{"name":49,"role":50,"phone":10,"phoneExt":10,"email":10},"Thomas Chang, DMP","PRINCIPAL_INVESTIGATOR",{"facility":52,"status":32,"city":53,"state":54,"zip":55,"country":36,"countryCode":37,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Fort Wayne Orthopedics","Fort Wayne","Indiana","46804",{"type":39,"coordinates":57},[58,59],-85.12886,41.1306,{"lat":59,"lon":58},[62,65],{"name":63,"role":23,"phone":64,"phoneExt":10,"email":10},"Faith Etherington, PA-C","260-436-8686",{"name":66,"role":50,"phone":10,"phoneExt":10,"email":10},"Matthew Beuchel, MD",{"facility":68,"status":32,"city":69,"state":70,"zip":71,"country":36,"countryCode":37,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Mercy Institute for Foot & Ankle Reconstruction","Baltimore","Maryland","21202",{"type":39,"coordinates":73},[74,75],-76.61219,39.29038,{"lat":75,"lon":74},[78,81,83,86,88],{"name":79,"role":23,"phone":10,"phoneExt":10,"email":80},"Maggie Manchester","mmanches@mdmercy.com",{"name":82,"role":50,"phone":10,"phoneExt":10,"email":10},"Patrick Maloney, MD",{"name":84,"role":85,"phone":10,"phoneExt":10,"email":10},"Clifford Jeng, MD","SUB_INVESTIGATOR",{"name":87,"role":85,"phone":10,"phoneExt":10,"email":10},"Lew Schon, MD",{"name":89,"role":85,"phone":10,"phoneExt":10,"email":10},"Rebecca Cerrato, MD",{"facility":91,"status":32,"city":92,"state":93,"zip":94,"country":36,"countryCode":37,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Duke Orthopeadics Arringdon","Morrisville","North Carolina","27560",{"type":39,"coordinates":96},[97,98],-78.82556,35.82348,{"lat":98,"lon":97},[101,105,107,109],{"name":102,"role":23,"phone":103,"phoneExt":10,"email":104},"Kalynn Purnell","919-681-6035","kalyn.purnell@duke.edu",{"name":106,"role":50,"phone":10,"phoneExt":10,"email":10},"Andrew Hanselman, MD",{"name":108,"role":85,"phone":10,"phoneExt":10,"email":10},"Mark Easley, MD",{"name":110,"role":85,"phone":10,"phoneExt":10,"email":10},"Samuel Adams, MD",{"facility":112,"status":32,"city":113,"state":114,"zip":115,"country":36,"countryCode":37,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":39,"coordinates":117},[118,119],-79.93275,32.77632,{"lat":119,"lon":118},[122,125,127],{"name":123,"role":23,"phone":10,"phoneExt":10,"email":124},"Josh Morningstar","morninjo@musc.edu",{"name":126,"role":50,"phone":10,"phoneExt":10,"email":10},"Christoper Gross, MD",{"name":128,"role":85,"phone":10,"phoneExt":10,"email":10},"Daniel Scott, MD",{"facility":130,"status":32,"city":131,"state":132,"zip":133,"country":36,"countryCode":37,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"UT Physicians Orthopedics - Pearland","Pearland","Texas","77584",{"type":39,"coordinates":135},[136,137],-95.28605,29.56357,{"lat":137,"lon":136},[140,144],{"name":141,"role":23,"phone":142,"phoneExt":10,"email":143},"Jordan Harmon","713-962-9954","jordan.j.harmon@uth.tmc.edu",{"name":145,"role":50,"phone":10,"phoneExt":10,"email":10},"Taggart Gauvain, MD",{"type":147,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100467272","patient-specific-talus-spacer-post-approval-study-100467272",false,"NCT05364606","Patient Specific Talus Spacer Post Approval Study","Inclusion Criteria:\n\n1. Subject plans to undergo implantation of the Patient Specific Talus Spacer for avascular necrosis of the ankle joint independent of this research protocol;\n2. Avascular necrosis of the ankle joint;\n3. Age 21 years old or older;\n4. Subject has good general health; and\n5. Subject signs a written informed consent form (ICF) prior to the surgical procedure.\n\nExclusion Criteria:\n\n1. Presence of any contraindication identified in the device Instructions for Use;\n2. Surgeon determines that the patient is not appropriate for the Talus Spacer procedure based on the device IFU (including the enumerated Warnings and Precautions);\n3. Based on the medical opinion of the surgeon, the patient is not appropriate for the Talus Spacer procedure;\n4. For female subjects, pregnancy;\n5. Active systemic disease, such as AIDS, HIV, or active infection;\n6. Active infection or the skin is compromised at the surgical site; and\n7. Systemic disease that would affect the subject's welfare;\n8. Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results;\n9. Is currently participating in an investigational therapy (device and\u002For pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the time course of follow-up.\n10. If the Sponsor has notified the site that 30 subjects have been enrolled in the study with a Cobalt Chromium Patient Specific Talus Spacer, and the surgeon believes that a Cobalt Chromium Patient Specific Talus Spacer is the best option for the patient.\n11. If the Sponsor has notified the site that 30 subjects have been enrolled in the study with a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer, and the surgeon believes that a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer is the best option for the patient.","ALL","21 Years",{"count":157,"type":158},50,"ESTIMATED","OBSERVATIONAL","Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.",[162],"Avascular Necrosis of the Talus",[164,165,166],"Avascular Necrosis","Talus","Ankle","2024-11-05",{"date":169,"type":170},"2024-11-07","ACTUAL",{"date":172,"type":170},"2022-07-08",{"date":174,"type":158},"2029-11-30",{"name":5,"class":6},6]