Multi-Plane Hallux Valgus Correction With the Phantom® Nail

NCT ID: NCT04084262

Last Updated: 2022-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-07
• Study Completion Date: 2022-05-09

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

All Study Participants

Phantom® Intramedullary Nail combined with a supinating reduction technique

Intramedullary Nail

Intervention Type: DEVICE

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

Interventions

Intramedullary Nail

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

Intervention Type: DEVICE

Other Intervention Names

Phantom® Intramedullary Nail

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Paragon 28

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Brinker, DPM

Role: STUDY_DIRECTOR

Director of Clinical Research

Locations

Orthopedic Center of Palm Beach County

Atlantis, Florida, United States

Countries

United States

Other Identifiers

P30-SP-0002

Identifier Type: -

Identifier Source: org_study_id