Patient Specific Talus Spacer Post Approval Study
ConditionAvascular Necrosis of the Talus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorParagon 28
About this trial
Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.
Eligibility criteria
Qualifiers
Subject plans to undergo implantation of the Patient Specific Talus Spacer for avascular necrosis of the ankle joint independent of this research protocol;
Avascular necrosis of the ankle joint;
Age 21 years old or older;
Subject has good general health; and
Disqualifiers
Presence of any contraindication identified in the device Instructions for Use;
Surgeon determines that the patient is not appropriate for the Talus Spacer procedure based on the device IFU (including the enumerated Warnings and Precautions);
Based on the medical opinion of the surgeon, the patient is not appropriate for the Talus Spacer procedure;
For female subjects, pregnancy;
Trial design
Treatments tested in this trial
- Patient Specific Talus Spacer
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov