Multi-Plane Hallux Valgus Correction With the Phantom® Nail

NCT04084262 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2022-09-23

No results posted yet for this study

Summary

The goal of this research study is to determine the change in frontal plane rotation of the 1st metatarsal from pre to post arthrodesis of the 1st TMT joint with the Phantom® Intramedullary Nail combined with a supinating reduction technique.

The study hypothesis is that multi-planar correction can be achieved with the Phantom® Intramedullary Nail.

Conditions

  • Arthrodesis
  • Bunion
  • Hallux Valgus

Interventions

DEVICE

Intramedullary Nail

Subjects undergo a Lapidus Arthrodesis procedure combined with a supinating reduction technique to create a multi-plane correction of hallux valgus

Sponsors & Collaborators

  • Paragon 28

    lead INDUSTRY

Principal Investigators

  • Laura Brinker, DPM · Director of Clinical Research

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-07
Primary Completion
2022-04-01
Completion
2022-05-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04084262 on ClinicalTrials.gov