[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Paragon 28\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":4,"eligibilityCriteria":13,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":20,"conditions":21,"keywords":23,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"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":17,"type":18},50,"ESTIMATED","OBSERVATIONAL","Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.",[22],"Avascular Necrosis of the Talus",[24,25,26],"Avascular Necrosis","Talus","Ankle","RECRUITING","2024-11-05",{"date":30,"type":31},"2024-11-07","ACTUAL",{"date":33,"type":31},"2022-07-08",{"date":35,"type":18},"2029-11-30",{"name":37,"class":38},"Paragon 28","INDUSTRY",6,""]