NCT04084262

Multi-Plane Hallux Valgus Correction With the Phantom® Nail

Correction of Multi-Plane Hallux Valgus Deformity Using the Phantom® Intramedullary Nail

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: Paragon 28 · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Arthrodesis
• Bunion
• Hallux Valgus

Interventions

Type	Name	Description
DEVICE	Intramedullary Nail	Subjects undergo a Lapidus Arthrodesis procedure combined with a supinating reduction technique to create a multi-plane correction of hallux valgus

Timeline

• Start date: 2019-11-07
• Primary completion: 2022-04-01
• Completion: 2022-05-09
• First posted: 2019-09-10
• Last updated: 2022-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study