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Clinical Trial Summary

Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05364606
Study type Observational
Source Paragon 28
Contact Jacy Legue
Phone 720-399-3400
Email jlegue@paragon28.com
Status Recruiting
Phase
Start date July 8, 2022
Completion date November 30, 2029

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06311331 - Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)
Recruiting NCT03965143 - Talus Replacement Registry