Multi-Plane Hallux Valgus Correction With the Phantom® Nail

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Arthrodesis, Bunion, Hallux Valgus

Intervention / Treatment
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* Device: Intramedullary Nail


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Study Participants<br>Phantom® Intramedullary Nail combined with a supinating reduction technique | Device: Intramedullary Nail<br>* Subjects undergo a Lapidus Arthrodesis procedure combined with a supinating reduction technique to create a multi-plane correction of hallux valgus<br>* Other names: Phantom® Intramedullary Nail;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bunion, supinating reduction, multi-plane, lapidus, arthrodesis, intramedullary nail, hallux valgus