NCT05364606

Patient Specific Talus Spacer Post Approval Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Paragon 28 · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Avascular Necrosis of the Talus

Interventions

Type	Name	Description
DEVICE	Patient Specific Talus Spacer	Patient Specific Talus Spacer is a solid polished replica of the patient's bone.

Timeline

• Start date: 2022-07-08
• Primary completion: 2029-08-30
• Completion: 2029-11-30
• First posted: 2022-05-06
• Last updated: 2024-11-07

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study