Multi-Plane Hallux Valgus Correction With the Phantom® Nail

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

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.

Study Overview

• Status: Completed
• Conditions: Bunion; Hallux Valgus; Arthrodesis
• Intervention / Treatment: Device: 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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • Florida
    • Atlantis, Florida, United States, 33462
      • Orthopedic Center of Palm Beach County

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adults age 18 and older with a hallux valgus deformity. The most common age demographic to have surgery for hallux valgus correction is age 50-59. Additionally, the prevalence of hallux valgus in females is greater than males, so a higher percentage of female subjects seeking treatment is likely to be expected.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Study Participants; Phantom® Intramedullary Nail combined with a supinating reduction technique	Device: Intramedullary Nail; Subjects undergo a Lapidus Arthrodesis procedure combined with a supinating reduction technique to create a multi-plane correction of hallux valgus; Other Names: Phantom® Intramedullary Nail

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Frontal Plane Rotation	Determine the change in frontal plane rotation of the 1st metatarsal from pre to post arthrodesis of the 1st tarsometatarsal joint with the Phantom® Intramedullary Nail combined with a supinating reduction technique.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-2 Inter Metatarsal Angle	Change in 1-2 Inter Metatarsal Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging	Pre-op, 2 weeks, 12 weeks
Meary's Angle	Change in Meary's Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging	Pre-op, 2 weeks, 12 weeks
Hallux Valgus Angle	Change in Hallux Valgus Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging	Pre-op, 2 weeks, 12 weeks
Metatarsus Adductus Angle	Change in Metatarsus Adductus Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging	Pre-op, 2 weeks, 12 weeks
Sesamoid Position	Change in sesamoid position before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging	Pre-op, 2 weeks, 12 weeks
Sesamoid Frontal Plane Rotation	Change in sesamoid frontal plane rotation before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging	Pre-op, 2 weeks, 12 weeks
Maintenance of Correction	Maintenance of lapidus arthrodesis correction via CBCT analysis	Pre-op, 2 weeks, 12 weeks
Union Status	Union/delayed union status at 12 Week Visit	12 weeks
Clinical Complications	Any lapidus arthrodesis related clinical complications	Pre-Op, 2 weeks, 6 weeks,12 weeks
Patient Current Level of Pain at Surgical Site	Visual Analog Scale (VAS). Line from 0 (no pain) to 10 (worst pain). Patient reported.	Pre-Op, 2 weeks, 6 weeks, 12 weeks
AOFAS	Change in AOFAS Hallux Metatarsophalangeal-Interphalangeal Scale scores AOFAS Hallux Metatarsophalangeal-Interphalangeal Scale foot clinical score. Pain: 0-40 points Function: 0-45 points Alignment: 0-15 points Total Score (sum): 0-100 points (higher score indicates better outcomes)	Pre-Op, 2 weeks, 6 weeks, 12 weeks
FAOS	Change in FAOS Foot and Ankle Survey scores Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Subscales: Pain Other Symptoms Functions in Daily Living (ADL) Function in sport and recreation Foot and ankle-related Quality of Life (QoL)	Pre-Op, 2 weeks, 6 weeks, 12 weeks
Patient Satisfaction with Procedure	Patient reported satisfaction by check boxes (Likert Scale) from Pain and Satisfaction Survey	Pre-Op, 2 weeks, 6 weeks, 12 weeks
Willingness to Undergo Procedure Again	Willingness to undergo procedure again (Yes/No)	12 weeks

Collaborators and Investigators

• Sponsor: Paragon 28
• Investigators: Study Director: Laura Brinker, DPM, Director of Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2019
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): May 9, 2022

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: arthrodesis; bunion; hallux valgus; intramedullary nail; lapidus; supinating reduction; multi-plane
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Hallux Valgus; Bunion
• Other Study ID Numbers: P30-SP-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No