CompletedNot Applicable

Multi-Plane Hallux Valgus Correction With the Phantom® Nail

United States12 participantsStarted 2019-11-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Frontal Plane Rotation

Timeframe: 12 weeks

Trial details

NCT IDNCT04084262

SponsorParagon 28

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-04-01

View on ClinicalTrials.gov More Arthrodesis trials