[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467272":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":31,"studyPopulation":32,"armGroups":33,"interventions":39,"overallOfficials":28,"centralContacts":45,"locations":54,"responsibleParty":171,"collaborators":28,"id":173,"slug":28,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":28,"eligibilityCriteria":177,"healthyVolunteers":174,"sex":178,"minAge":179,"maxAge":28,"enrollmentInfo":180,"targetDuration":28,"studyType":183,"phases":28,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":57,"whyStopped":28,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},{"fullName":5,"class":6},"Paragon 28","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":22},[9,13],{"measure":10,"description":11,"timeFrame":12},"Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS)","Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS) at 5 years compared to baseline on the 0 to 100mm scale. A lower score will indicate an improvement in pain.","At 5 years compared to Baseline",{"measure":14,"description":15,"timeFrame":16},"A lack Secondary Subsequent Surgical Intervention at 5 years Post Operative assessed during the subject's visits","A lack Secondary Subsequent Surgical Intervention (SSSI) at 5 years Post Operative","A patient will achieve the primary probable benefit endpoint only is they do not undergo a Secondary Subsequent Surgical Intervention at 5 years Post Operative as assessed during the subjects visits for the study.",[18],{"measure":19,"description":20,"timeFrame":21},"Additional Analyses at 5 years Post Operative compared to baseline, Range of Motion of the Ankle.","Additional analyses will be performed to observe improvement at 5-years post-procedure compared to baseline on ankle range of motion (ROM) as assessed by the surgeon at each follow up visit through 5 years Post Operative.","5 Years Post Procedure compared to baseline.",[23],{"measure":24,"description":25,"timeFrame":26},"Additional Analyses at 5 Years Post Operative compared to Baseline for Foot and Outcome Score FAOS","Additional analyses will be performed to observe improvement at 5-years post-procedure compared to baseline on Foot and Ankle Outcome Score (FAOS - which include Pain, Other Symptoms, Sport and Recreation Function, Activities of Daily Living (ADL) and Foot and Ankle related Quality of Life (QOL). This is a series of questions for each sub section that the subject will answer at the subjects visits.","5 Years Post Procedure compared to baseline",{"allocation":28,"interventionModel":28,"interventionModelDescription":28,"primaryPurpose":28,"observationalModel":29,"timePerspective":30,"maskingInfo":28},null,"CASE_ONLY","PROSPECTIVE","This is a Humanitarian Device Exemption (HDE) approved device called the Patient Specific Talus Spacer. This is a post approval study to determine the safety and probable benefit of the Patient Specific Talus Spacer in commercial use. The Patient Specific Talus Spacer is a solid polished replica of the patient's bone to allow the patient to regain motion and reduce pain.","Patients with Avascular Necrosis of the Ankle Joint.",[34],{"label":35,"type":28,"description":36,"interventionNames":37},"50 Subjects","50 Subjects Receiving the Patient Specific Talus Spacer.",[38],"Device: Patient Specific Talus Spacer",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":28},"DEVICE","Patient Specific Talus Spacer","Patient Specific Talus Spacer is a solid polished replica of the patient's bone.",[35],[46,51],{"name":47,"role":48,"phone":49,"phoneExt":28,"email":50},"Jacy Legue","CONTACT","720-399-3400","jlegue@paragon28.com",{"name":52,"role":48,"phone":49,"phoneExt":28,"email":53},"Caleigh Bates","cbates@paragon28.com",[55,76,92,115,136,154],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Redwood Orthopaedics","RECRUITING","Santa Rosa","California","95403","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-122.71443,38.44047,{"lat":67,"lon":66},[70,73],{"name":71,"role":48,"phone":72,"phoneExt":28,"email":28},"Thomas Chang, DPM","707-544-3400",{"name":74,"role":75,"phone":28,"phoneExt":28,"email":28},"Thomas Chang, DMP","PRINCIPAL_INVESTIGATOR",{"facility":77,"status":57,"city":78,"state":79,"zip":80,"country":61,"countryCode":62,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Fort Wayne Orthopedics","Fort Wayne","Indiana","46804",{"type":64,"coordinates":82},[83,84],-85.12886,41.1306,{"lat":84,"lon":83},[87,90],{"name":88,"role":48,"phone":89,"phoneExt":28,"email":28},"Faith Etherington, PA-C","260-436-8686",{"name":91,"role":75,"phone":28,"phoneExt":28,"email":28},"Matthew Beuchel, MD",{"facility":93,"status":57,"city":94,"state":95,"zip":96,"country":61,"countryCode":62,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Mercy Institute for Foot & Ankle Reconstruction","Baltimore","Maryland","21202",{"type":64,"coordinates":98},[99,100],-76.61219,39.29038,{"lat":100,"lon":99},[103,106,108,111,113],{"name":104,"role":48,"phone":28,"phoneExt":28,"email":105},"Maggie Manchester","mmanches@mdmercy.com",{"name":107,"role":75,"phone":28,"phoneExt":28,"email":28},"Patrick Maloney, MD",{"name":109,"role":110,"phone":28,"phoneExt":28,"email":28},"Clifford Jeng, MD","SUB_INVESTIGATOR",{"name":112,"role":110,"phone":28,"phoneExt":28,"email":28},"Lew Schon, MD",{"name":114,"role":110,"phone":28,"phoneExt":28,"email":28},"Rebecca Cerrato, MD",{"facility":116,"status":57,"city":117,"state":118,"zip":119,"country":61,"countryCode":62,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Duke Orthopeadics Arringdon","Morrisville","North Carolina","27560",{"type":64,"coordinates":121},[122,123],-78.82556,35.82348,{"lat":123,"lon":122},[126,130,132,134],{"name":127,"role":48,"phone":128,"phoneExt":28,"email":129},"Kalynn Purnell","919-681-6035","kalyn.purnell@duke.edu",{"name":131,"role":75,"phone":28,"phoneExt":28,"email":28},"Andrew Hanselman, MD",{"name":133,"role":110,"phone":28,"phoneExt":28,"email":28},"Mark Easley, MD",{"name":135,"role":110,"phone":28,"phoneExt":28,"email":28},"Samuel Adams, MD",{"facility":137,"status":57,"city":138,"state":139,"zip":140,"country":61,"countryCode":62,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":64,"coordinates":142},[143,144],-79.93275,32.77632,{"lat":144,"lon":143},[147,150,152],{"name":148,"role":48,"phone":28,"phoneExt":28,"email":149},"Josh Morningstar","morninjo@musc.edu",{"name":151,"role":75,"phone":28,"phoneExt":28,"email":28},"Christoper Gross, MD",{"name":153,"role":110,"phone":28,"phoneExt":28,"email":28},"Daniel Scott, MD",{"facility":155,"status":57,"city":156,"state":157,"zip":158,"country":61,"countryCode":62,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"UT Physicians Orthopedics - Pearland","Pearland","Texas","77584",{"type":64,"coordinates":160},[161,162],-95.28605,29.56357,{"lat":162,"lon":161},[165,169],{"name":166,"role":48,"phone":167,"phoneExt":28,"email":168},"Jordan Harmon","713-962-9954","jordan.j.harmon@uth.tmc.edu",{"name":170,"role":75,"phone":28,"phoneExt":28,"email":28},"Taggart Gauvain, MD",{"type":172,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","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":181,"type":182},50,"ESTIMATED","OBSERVATIONAL","Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.",[186],"Avascular Necrosis of the Talus",[188,189,190],"Avascular Necrosis","Talus","Ankle","2024-11-05",{"date":193,"type":194},"2024-11-07","ACTUAL",{"date":196,"type":194},"2022-07-08",{"date":198,"type":182},"2029-11-30",{"name":5,"class":6},6]