Multi-Plane Hallux Valgus Correction With the Phantom® Nail

Completed

Conditions studied: Arthrodesis, Bunion, Hallux Valgus

In brief

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.

Key facts

Study ID

NCT04084262

Run by

Paragon 28

People needed

12

Starts

2019-11-07

Expected to finish

2022-05-09

Last updated by the study team

2022-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is at least 18 years of age at the time of screening.
• The subject has been diagnosed with hallux valgus.
• The subject has pain associated with hallux valgus.
• The subject agrees to comply with the requirements of the study and complete the study measures.
• The subject is willing and able to provide written informed consent.
• The subject plans to undergo a Lapidus Arthrodesis procedure with a 3-Hole Phantom® Intramedullary Nail.

You may not qualify if…

• The subject is pregnant.
• The subject has had previous surgery for hallux valgus on operative side.
• The subject will require a structural graft in the 1st TMT joint.
• The unshod foot in question is greater than 28 cm in length.
• The subject is not expected to complete the study according to the investigation plan.
• The subject has been deemed physiologically or psychologically inadequate by the enrolling physician.
• The subject is a prisoner, unable to understand what participation in the study entails, mentally incompetent, a known abuser of alcohol and/or drugs, or anticipated to be non-compliant.

Where it is running

• Orthopedic Center of Palm Beach County — Atlantis, Florida, United States

Full record on ClinicalTrials.gov

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