Study of Adductoplasty and Lapiplasty Procedures for Correcting Metatarsus Adductus and Hallux Valgus in Patients Aged 14 to 65

What this Trial Is About

Researchers are evaluating the outcomes of combining the Adductoplasty12 and Lapiplastyae Procedures for patients who need surgery to correct metatarsus adductus and hallux valgus. This study aims to assess how well these procedures improve quality of life and reduce pain, as well as to determine if they effectively correct and maintain the alignment of the first three metatarsals, hallux position, sesamoid position, and foot width. The trial is a prospective, multicenter, unblinded study involving up to 80 participants aged 14 years and older with symptomatic conditions. Participants will undergo the combined Adductoplasty12 and Lapiplastyae Procedures, which involve surgical correction of foot deformities. The study duration extends up to five years following the initial surgery. There are no comparator groups mentioned as this is a single arm intervention study conducted across multiple clinical sites. The procedures are performed under general anesthesia, and patients must be able to adhere to postoperative care instructions. During the study, participants will be assessed at various intervals up to 60 months after the procedure. Evaluations include radiographic imaging to check for recurrence of deformities, measurement of pain and quality of life changes, range of motion, foot width, and monitoring of clinical complications. Weight-bearing recovery times and return to unrestricted activity will also be tracked. These outcomes will help researchers understand the effectiveness and durability of the combined surgical approach.

Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)