Multi-Plane Hallux Valgus Correction With the Phantom® Nail

Paragon 28

Status: Completed

Conditions: Hallux Valgus; Bunion; Arthrodesis

Treatments: Device: Intramedullary Nail

Study type: Observational

Funder types: Industry

Identifiers

NCT04084262

P30-SP-0002

Details and patient eligibility

About

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.

Full description

Each subject will undergo a Lapidus Arthrodesis combined with a supinating reduction technique.

The subjects will undergo 3 weight-bearing CBCT scans of their foot and ankle, one pre-arthrodesis, one two weeks post-arthrodesis, and one 12 weeks post-arthrodesis. These scans will be used to determine change in frontal plane rotation of the 1st metatarsal from pre to post arthrodesis of the 1st TMT joint, change in angular/positional alignment of the 1st TMT joint using various measurements (1-2 IMA, Meary's Angle, HVA, MAA, Sesamoid Position, and Sesamoid Frontal Plane Rotation), maintenance of correction of the 1st TMT joint, and union status.

The subjects will also complete three surveys, the Pain and Satisfaction Survey, the AOFAS Hallux MTP-IP Scale, and the FAOS Foot and Ankle Survey, at the Pre-Operative Visit, 2 Week Visit (post-op), 6 Week Visit (post-op), and 12 Week Visit (post-op). Furthermore, the subjects will be asked about their willingness to undergo the procedure again at the 12 Week Visit (post-op). All of these scores will be considered in the secondary objectives.

Aside from the study activities listed above, all procedures, visits, and instructions for the subject are to follow the standard of care.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

12 participants in 1 patient group

All Study Participants

Description:

Phantom® Intramedullary Nail combined with a supinating reduction technique

Treatment:

Device: Intramedullary Nail