Actively Recruiting
Patient Specific Talus Spacer Post Approval Study
Led by Paragon 28 · Updated on 2024-11-07
50
Participants Needed
6
Research Sites
386 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.
CONDITIONS
Official Title
Patient Specific Talus Spacer Post Approval Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject plans to undergo implantation of the Patient Specific Talus Spacer for avascular necrosis of the ankle joint independent of this research protocol
- Diagnosis of avascular necrosis of the ankle joint
- Age 21 years old or older
- Subject is in good general health
- Subject signs a written informed consent form prior to surgery
You will not qualify if you...
- Any contraindication identified in the device Instructions for Use
- Surgeon determines patient is not appropriate for the Talus Spacer procedure based on device IFU or medical opinion
- Pregnancy for female subjects
- Active systemic disease such as AIDS, HIV, or active infection
- Active infection or compromised skin at the surgical site
- Systemic disease affecting subject's welfare
- Prisoner, incarcerated, or coerced participation
- Participation in investigational therapy within 30 days prior to study or planned during follow-up
- Enrollment limits reached for specific Patient Specific Talus Spacer materials if surgeon believes those options are best
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Redwood Orthopaedics
Santa Rosa, California, United States, 95403
Actively Recruiting
2
Fort Wayne Orthopedics
Fort Wayne, Indiana, United States, 46804
Actively Recruiting
3
Mercy Institute for Foot & Ankle Reconstruction
Baltimore, Maryland, United States, 21202
Actively Recruiting
4
Duke Orthopeadics Arringdon
Morrisville, North Carolina, United States, 27560
Actively Recruiting
5
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
6
UT Physicians Orthopedics - Pearland
Pearland, Texas, United States, 77584
Actively Recruiting
Research Team
J
Jacy Legue
CONTACT
C
Caleigh Bates
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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