Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 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 9. Female patients must be of non-childbearing potential or have a negative pregnancy test in accordance with hospital standards prior to the Index Procedure 10. Willing and able to schedule index procedure within 3 months of consent and able to return for scheduled follow-up visits 11. Willing and able to provide written informed consent 12. Patient agrees to refrain from any reconstructive procedures on contralateral foot for minimum of 6 months post index procedure Exclusion Criteria: 1. Previous surgery for