Post Approval Study of a Custom Talus Spacer for Ankle Avascular Necrosis

Patient Specific Talus Spacer Post Approval Study

This study is testing a custom-made device for people with ankle avascular necrosis to see if it can help reduce pain and improve movement.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Paragon 28 (industry)
• Locations: 6 sites (Santa Rosa, California and 5 other locations)
• Trial ID: NCT05364606 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the safety and probable benefits of the Patient Specific Talus Spacer, a device designed for patients with avascular necrosis of the ankle joint. The spacer is a custom-made replica of the patient's bone, aimed at restoring motion and alleviating pain. Participants will undergo implantation of the spacer as part of their standard care, independent of the research protocol, while data will be collected to assess outcomes. The study is conducted under a Humanitarian Device Exemption, indicating its potential significance for patients with this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 and older with avascular necrosis of the ankle joint who are scheduled for implantation of the Patient Specific Talus Spacer.

Not a fit: Patients with contraindications to the device or those with active systemic diseases or infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new option for patients suffering from avascular necrosis of the talus, improving their mobility and reducing pain.

How similar studies have performed: While this approach is based on a Humanitarian Device Exemption, similar studies using custom implants have shown promise in improving patient outcomes.

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. 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.

Where this trial is running

Santa Rosa, California and 5 other locations

• Redwood Orthopaedics — Santa Rosa, California, United States (RECRUITING)
• Fort Wayne Orthopedics — Fort Wayne, Indiana, United States (RECRUITING)
• Mercy Institute for Foot & Ankle Reconstruction — Baltimore, Maryland, United States (RECRUITING)
• Duke Orthopeadics Arringdon — Morrisville, North Carolina, United States (RECRUITING)
• Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
• UT Physicians Orthopedics - Pearland — Pearland, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Jacy Legue

Conditions: Avascular Necrosis of the Talus, Avascular Necrosis, Talus, Ankle