Patient Specific Talus Spacer Post Approval Study
Paragon 28
Summary
Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.
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 Specific Talus Spacer in commercial use. The Patient Specific Talus Spacer is a solid polished replica of the patient's bone to allow the patient to regain motion and reduce pain.
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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 (i…
Interventions
- DevicePatient Specific Talus Spacer
Patient Specific Talus Spacer is a solid polished replica of the patient's bone.
Locations (6)
- Redwood OrthopaedicsSanta Rosa, California
- Fort Wayne OrthopedicsFort Wayne, Indiana
- Mercy Institute for Foot & Ankle ReconstructionBaltimore, Maryland
- Duke Orthopeadics ArringdonMorrisville, North Carolina
- Medical University of South CarolinaCharleston, South Carolina
- UT Physicians Orthopedics - PearlandPearland, Texas