Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS)
Timeframe: At 5 years compared to Baseline
A lack Secondary Subsequent Surgical Intervention at 5 years Post Operative assessed during the subject's visits
Timeframe: A patient will achieve the primary probable benefit endpoint only is they do not undergo a Secondary Subsequent Surgical Intervention at 5 years Post Operative as assessed during the subjects visits for the study.