Multi-Plane Hallux Valgus Correction With the Phantom® Nail

Completed

• Conditions: Arthrodesis; Bunion; Hallux Valgus
• Interventions: Device: Intramedullary Nail

• Registration Number: NCT04084262
• Lead Sponsor: Paragon 28

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.

Study Timeline

• Study First Submitted: 2019-09-06
• Study First Submitted QC: 2019-09-06
• Study First Posted: 2019-09-10
• Study Start: 2019-11-07
• Primary Completion: 2022-04-01
• Study Completion: 2022-05-09
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Study Participants	Intramedullary Nail	Phantom® Intramedullary Nail combined with a supinating reduction technique

Primary Outcome Measures

Name	Time	Method
Change in Frontal Plane Rotation	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Complications	Pre-Op, 2 weeks, 6 weeks,12 weeks	Any lapidus arthrodesis related clinical complications
Patient Current Level of Pain at Surgical Site	Pre-Op, 2 weeks, 6 weeks, 12 weeks	Visual Analog Scale (VAS). Line from 0 (no pain) to 10 (worst pain). Patient reported.
Meary's Angle	Pre-op, 2 weeks, 12 weeks	Change in Meary's Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging
Sesamoid Frontal Plane Rotation	Pre-op, 2 weeks, 12 weeks	Change in sesamoid frontal plane rotation before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging
FAOS	Pre-Op, 2 weeks, 6 weeks, 12 weeks	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)
Metatarsus Adductus Angle	Pre-op, 2 weeks, 12 weeks	Change in Metatarsus Adductus Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging
Sesamoid Position	Pre-op, 2 weeks, 12 weeks	Change in sesamoid position before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging
Maintenance of Correction	Pre-op, 2 weeks, 12 weeks	Maintenance of lapidus arthrodesis correction via CBCT analysis
Union Status	12 weeks	Union/delayed union status at 12 Week Visit
AOFAS	Pre-Op, 2 weeks, 6 weeks, 12 weeks	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)
Patient Satisfaction with Procedure	Pre-Op, 2 weeks, 6 weeks, 12 weeks	Patient reported satisfaction by check boxes (Likert Scale) from Pain and Satisfaction Survey
Willingness to Undergo Procedure Again	12 weeks	Willingness to undergo procedure again (Yes/No)
1-2 Inter Metatarsal Angle	Pre-op, 2 weeks, 12 weeks	Change in 1-2 Inter Metatarsal Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging
Hallux Valgus Angle	Pre-op, 2 weeks, 12 weeks	Change in Hallux Valgus Angle before and after arthrodesis of the 1st tarsometatarsal joint using weightbearing CBCT imaging

Trial Locations

Locations (1)

Orthopedic Center of Palm Beach County; 🇺🇸 Atlantis, Florida, United States