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NCT05364606 · ClinicalTrials.gov registry record

Patient Specific Talus Spacer Post Approval Study

A clinical trial of Avascular Necrosis of the Talus, sponsored by Paragon 28.

Recruiting
Registry status
50
Enrollment target
6
Study locations

NCT05364606: Recruiting study of Avascular Necrosis of the Talus, sponsored by Paragon 28.

NCT05364606 is a study of Avascular Necrosis of the Talus that is actively recruiting participants, run by Paragon 28. The registered enrollment target is 50 participants. The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05364606, a study of Avascular Necrosis of the Talus, is actively recruiting participants, sponsored by Paragon 28.

RECRUITING
Registry status
50 participants
Enrollment target
6
Study locations

Study Summary

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

Primary Outcome

Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS) at 5 years compared to baseline on the 0 to 100mm scale. A lower score will indicate an improvement in pain.

Interventions

  • DEVICE Patient Specific Talus Spacer

Study Locations (6)

California

  • Redwood Orthopaedics - Santa Rosa

Indiana

  • Fort Wayne Orthopedics - Fort Wayne

Maryland

  • Mercy Institute for Foot & Ankle Reconstruction - Baltimore

North Carolina

  • Duke Orthopeadics Arringdon - Morrisville

South Carolina

  • Medical University of South Carolina - Charleston

Texas

  • UT Physicians Orthopedics - Pearland - Pearland

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2022-07-08
Est. Completion 2029-11-30
Paragon 28

7 total trials

What NCT05364606 shows while recruiting

NCT05364606 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.

The record links to 1 condition, with Avascular Necrosis of the Talus appearing as the primary indexed condition, and to 1 intervention - of which Patient Specific Talus Spacer is the first listed.

NCT05364606 lists 6 locations in 6 states (California, Indiana, Maryland).

Frequently Asked Questions

What is clinical trial NCT05364606 about?

NCT05364606 is a clinical study titled "Patient Specific Talus Spacer Post Approval Study". Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.

What is the current status of trial NCT05364606?

This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2022-07-08. Estimated completion is 2029-11-30.

What conditions does trial NCT05364606 study?

This clinical trial studies the following conditions: Avascular Necrosis of the Talus.

What interventions are being tested in trial NCT05364606?

The interventions under investigation include: Patient Specific Talus Spacer (DEVICE).

Who is sponsoring clinical trial NCT05364606?

This trial is sponsored by Paragon 28, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05364606 being conducted?

This trial has 6 study locations across California, Indiana, Maryland, North Carolina, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05364606, the US trial registry maintained by the National Library of Medicine. NCT05364606 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.