Post Approval Study of a Custom Talus Spacer for Ankle Avascular Necrosis
Official title: Patient Specific Talus Spacer Post Approval Study
Run by Paragon 28 · NCT05364606 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Paragon 28 Industry-sponsored |
| Locations | 5 sites (Santa Rosa, California and 4 other locations) |
| Status | Recruiting |
| Started | July 8, 2022 |
| Main results expected | August 30, 2033 |
| Study ends | November 30, 2033 |
| Registry record updated | September 16, 2026 |
| Trial ID | NCT05364606 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with contraindications to the device or those with active systemic diseases or infections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is based on a Humanitarian Device Exemption, similar studies using custom implants have shown promise in improving patient outcomes.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Sutter Health Santa Rosa
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 -
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
- Email: jlegue@paragon28.com
- Phone: 720-399-3400
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Registry for 3D talus replacement in patients with avascular necrosis
This study is testing a new 3D talus replacement procedure to see if it helps people with avascular necrosis of the talus recover better and improve their foot function.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.