Status:
RECRUITING
Patient Specific Talus Spacer Post Approval Study
Lead Sponsor:
Paragon 28
Conditions:
Avascular Necrosis of the Talus
Eligibility:
All Genders
21+ years
Brief Summary
Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.
Detailed Description
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 Specif...
Eligibility Criteria
Inclusion
- Subject plans to undergo implantation of the Patient Specific Talus Spacer for avascular necrosis of the ankle joint independent of this research protocol;
- Avascular necrosis of the ankle joint;
- Age 21 years old or older;
- Subject has good general health; and
- Subject signs a written informed consent form (ICF) prior to the surgical procedure.
Exclusion
- Presence of any contraindication identified in the device Instructions for Use;
- Surgeon determines that the patient is not appropriate for the Talus Spacer procedure based on the device IFU (including the enumerated Warnings and Precautions);
- Based on the medical opinion of the surgeon, the patient is not appropriate for the Talus Spacer procedure;
- For female subjects, pregnancy;
- Active systemic disease, such as AIDS, HIV, or active infection;
- Active infection or the skin is compromised at the surgical site; and
- Systemic disease that would affect the subject's welfare;
- Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results;
- 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.
- 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.
- 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.
Key Trial Info
Start Date :
July 8 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05364606
Start Date
July 8 2022
End Date
November 30 2029
Last Update
November 7 2024
Active Locations (6)
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1
Redwood Orthopaedics
Santa Rosa, California, United States, 95403
2
Fort Wayne Orthopedics
Fort Wayne, Indiana, United States, 46804
3
Mercy Institute for Foot & Ankle Reconstruction
Baltimore, Maryland, United States, 21202
4
Duke Orthopeadics Arringdon
Morrisville, North Carolina, United States, 27560