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