Clinical trial NCT04084262: Multi-Plane Hallux Valgus Correction With the Phantom® Nail
Official title: Correction of Multi-Plane Hallux Valgus Deformity Using the Phantom® Intramedullary Nail
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthrodesis
Bunion
Hallux Valgus
Keywords: bunion
supinating reduction
multi-plane
lapidus
arthrodesis
intramedullary nail
hallux valgus
Lead sponsor: Paragon 28
Sponsor class: INDUSTRY
First posted: 2019-09-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Change in Frontal Plane Rotation
timeFrame: 12 weeks
Secondary outcomes:
measure: 1-2 Inter Metatarsal Angle
timeFrame: Pre-op, 2 weeks, 12 weeks
measure: Meary's Angle
timeFrame: Pre-op, 2 weeks, 12 weeks
measure: Hallux Valgus Angle
timeFrame: Pre-op, 2 weeks, 12 weeks
measure: Metatarsus Adductus Angle
timeFrame: Pre-op, 2 weeks, 12 weeks
measure: Sesamoid Position
timeFrame: Pre-op, 2 weeks, 12 weeks
measure: Sesamoid Frontal Plane Rotation
timeFrame: Pre-op, 2 weeks, 12 weeks
measure: Maintenance of Correction
timeFrame: Pre-op, 2 weeks, 12 weeks
measure: Union Status
timeFrame: 12 weeks
measure: Clinical Complications
timeFrame: Pre-Op, 2 weeks, 6 weeks,12 weeks
measure: Patient Current Level of Pain at Surgical Site
timeFrame: Pre-Op, 2 weeks, 6 weeks, 12 weeks
measure: AOFAS
timeFrame: Pre-Op, 2 weeks, 6 weeks, 12 weeks
measure: FAOS
timeFrame: Pre-Op, 2 weeks, 6 weeks, 12 weeks
measure: Patient Satisfaction with Procedure
timeFrame: Pre-Op, 2 weeks, 6 weeks, 12 weeks
measure: Willingness to Undergo Procedure Again
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Atlantis
country: United States
facility: Orthopedic Center of Palm Beach County
state: Florida
Study officials:
affiliation: Director of Clinical Research
name: Laura Brinker, DPM
role: STUDY_DIRECTOR
References: