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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Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)
At a glance
Conditions
Where it's being run
9 sites across 8 statesStudy leadership
- Paul Dayton, DPM · PRINCIPAL_INVESTIGATOR · Foot and Ankle Center of Iowa
- Mark Easley, MD · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
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What this trial measures
- 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°.