Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2022-07-08
2029-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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50 Subjects
50 Subjects Receiving the Patient Specific Talus Spacer.
Patient Specific Talus Spacer
Patient Specific Talus Spacer is a solid polished replica of the patient's bone.
Interventions
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Patient Specific Talus Spacer
Patient Specific Talus Spacer is a solid polished replica of the patient's bone.
Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
ALL
No
Sponsors
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Paragon 28
INDUSTRY
Responsible Party
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Locations
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Redwood Orthopaedics
Santa Rosa, California, United States
Fort Wayne Orthopedics
Fort Wayne, Indiana, United States
Mercy Institute for Foot & Ankle Reconstruction
Baltimore, Maryland, United States
Duke Orthopeadics Arringdon
Morrisville, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
UT Physicians Orthopedics - Pearland
Pearland, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Thomas Chang, DPM
Role: primary
Faith Etherington, PA-C
Role: primary
Other Identifiers
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AOPSTSPAS
Identifier Type: -
Identifier Source: org_study_id
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