Stow

Researchers are evaluating the outcomes of the Adductoplasty12 Procedure combined with the Lapiplastyae Procedure for patients needing correction of metatarsus adductus and hallux valgus. This prospective, multicenter, unblinded study will include up to 80 subjects aged 14 to 65 years across up to 13 clinical sites. The study aims to assess quality of life, pain scores, and the effectiveness of these procedures in correcting and maintaining the alignment of the first three metatarsals, the hallux position, sesamoid position, and foot width. Participants will receive treatment involving the combined Adductoplasty12 and Lapiplastyae Procedures. Eligible patients are those 14 years or older with symptomatic metatarsus adductus and hallux valgus who meet the defined criteria. The anticipated study duration is five years following the initial procedure, allowing for long-term evaluation of treatment outcomes. During the study, researchers will monitor radiographic recurrence of the hallux valgus deformity with metatarsus adductus at 24 months for those with successful correction. Participants will complete self-administered questionnaires to evaluate quality of life and pain. The study includes scheduled follow-up visits to assess anatomical alignment, patient-reported outcomes, and overall safety throughout the study period.