An observational study in Arthrodesis, Bunion and Hallux Valgus, sponsored by Paragon 28. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-23.
Sponsored by Paragon 28 · Observational
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.
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.
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.
Exclusion Criteria:
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
Also known as: Phantom® Intramedullary Nail
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.
Time frame: 12 weeks
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-op, 2 weeks, 12 weeks
Maintenance of Correction
Maintenance of lapidus arthrodesis correction via CBCT analysis
Time frame: Pre-op, 2 weeks, 12 weeks
Union Status
Union/delayed union status at 12 Week Visit
Time frame: 12 weeks
Clinical Complications
Any lapidus arthrodesis related clinical complications
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Pre-Op, 2 weeks, 6 weeks, 12 weeks
Willingness to Undergo Procedure Again
Willingness to undergo procedure again (Yes/No)
Time frame: 12 weeks
Plan to share: No
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