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โ† Trials
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Patient Specific Talus Spacer Post Approval Study

Recruitingn/aAges 21 Years - anyAllParagon 28
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In plain words

What the trial is, and whether it could suit you

Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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. Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results; 9. Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the time course of follow-up. 10. 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. 11. 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.
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What it tests

  • Patient Specific Talus Spacer
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Where

5 sites
Sutter Health Santa Rosa
Santa Rosa, United States
Fort Wayne Orthopedics
Fort Wayne, United States
Mercy Institute for Foot & Ankle Reconstruction
Baltimore, United States
Medical University of South Carolina
Charleston, United States
UT Physicians Orthopedics - Pearland
Pearland, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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