NCT05364606 Patient Specific Talus Spacer Post Approval Study
| NCT ID | NCT05364606 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Paragon 28 |
| Condition | Avascular Necrosis of the Talus |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-07-08 |
| Primary Completion | 2029-08-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.
Eligibility Criteria
Inclusion Criteria: 1. Subject plans to undergo implantation of the Patient Specific Talus Spacer for avascular necrosis of the ankle joint independent of this research protocol; 2. Avascular necrosis of the ankle joint; 3. Age 21 years old or older; 4. Subject has good general health; and 5. Subject signs a written informed consent form (ICF) prior to the surgical procedure. Exclusion Criteria: 1. Presence of any contraindication identified in the device Instructions for Use; 2. Surgeon determines that the patient is not appropriate for the Talus Spacer procedure based on the device IFU (including the enumerated Warnings and Precautions); 3. Based on the medical opinion of the surgeon, the patient is not appropriate for the Talus Spacer procedure; 4. For female subjects, pregnancy; 5. Active systemic disease, such as AIDS, HIV, or active infection; 6. Active infection or the skin is compromised at the surgical site; and 7. Systemic disease that would affect the subject's welfare; 8. I