Outcomes Following Combined Adductoplasty™ and Lapiplasty® for Foot Deformities

This study is looking at how well two procedures, Adductoplasty™ and Lapiplasty®, work together to correct common foot deformities called metatarsus adductus and hallux valgus (bunions). Researchers want to see if this combined treatment improves your quality of life and pain, and if it effectively straightens the bones in your foot. You might be able to join if you are between 14 and 65 years old, have closed growth plates, and meet specific measurements for your foot angles. The study aims to enroll up to 80 participants across several clinics. Success will be measured by checking if the bunion deformity returns after 24 months.

Study design
This is a prospective, multicenter, unblinded study that plans to enroll up to 80 participants.
What's involved
You would receive the Adductoplasty™ and Lapiplasty® procedures. You will need to follow post-operative care instructions.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 5 years after the procedure, with a key evaluation of the deformity at 24 months.

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NCT05587569

Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)

Recruiting
NAAges 14–65InterventionalTreatment
Treace Medical Concepts, Inc.
~80 participants
Updated 2025-05-25 on ClinicalTrials.gov
What's tested:Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiographic recurrence of hallux valgus deformity with metatarsus adductus will be evaluated at 24 months for subjects wtih successful correction
Measured over 24 Months
Metatarsus Adductus
Hallux Valgus
9 sites across 8 states
Ohio2
Colorado1
Iowa1
Maine1
Missouri1
North Carolina1
Pennsylvania1
Texas1
  • Paul Dayton, DPM · PRINCIPAL_INVESTIGATOR · Foot and Ankle Center of Iowa
  • Mark Easley, MD · PRINCIPAL_INVESTIGATOR · Duke University

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  • Radiographic recurrence of hallux valgus deformity with metatarsus adductus will be evaluated at 24 months for subjects wtih successful correction24 Months

    Successful correction is defined as two of the following three criteria: measured IMA \<9.0°, HVA \<15.0°, and TSP as ≤3 at 6 months post Adductoplasty® Procedure and Lapiplasty® Procedure. Recurrence at 24 months is defined by HVA \>15.0°.