Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)
Eligible age
14–65 yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
Yes
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About this study
Prospective, multicenter, unblinded study to evaluate outcomes of the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure for patients in need of metatarsus adductus and hallux valgus correction. Up to 80 subjects will be treated in this study at up to 13 clinical sites. Patients 14 years of age or older with symptomatic metatarsus adductus and hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.
Sponsor: Treace Medical Concepts, Inc.
You may qualify if…
- ✓ 1. Male and females ≥14 years old at the time of consent
- ✓ 2. Closed physeal plates at the time of consent
- ✓ 3. Intermetatarsal angle is ≥8.0˚; OR True IMA of \>10°, (IMA+MTA-15=True IMA)
- ✓ 4. Hallux valgus angle is ≥12.0˚
- ✓ 5. Metatarsus adductus angle based on Sgarlatos method ≥15°
- ✓ 6. Willing and able to adhere to post-op care instructions
- ✓ 7. Capable of completing self-administered questionnaires
- ✓ 8. Acceptable surgical candidate, including use of general anesthesia
You may not qualify if…
- ✕ 1. Previous surgery for hallux valgus on operative side
- ✕ 2. Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe, lesser toes/digits, or posterior muscle lengthening)
- ✕ 3. Moderate-severe osteoarthritis of the foot or ankle outside of the 1st, 2nd or 3rd tarsometatarsal joints
- ✕ 4. Severe osteoarthritis of the 1st, 2nd or 3rd tarsometatarsal joints
- ✕ 5. Any deformity of the hindfoot or midfoot that represents a pathological condition that may affect the outcome of the tarsometatarsal realignment, or a condition that requires concomitant surgical correction
- ✕ 6. BMI \>40 kg/m²
- ✕ 7. Current nicotine user in any form including vaping, smoking, oral ingestion or use of nicotine patch
- ✕ 8. Current clinical diagnosis of diabetes or currently taking medication for treatment of diabetes
Where it's recruiting
Greeley
Ankeny
Yarmouth
Jefferson City
Morrisville
Canton · Stow
Wexford
Keller
Source: ClinicalTrials.gov · NCT05587569 · last updated 2025-05-25