Evaluation of the VIRTUGUIDE System and DePuy Synthes Lapidus Implant for Correction of Hallux Valgus Using the Lapidus Procedure

What this Trial Is About

Researchers are evaluating the surgeon experience and surgery outcomes in participants undergoing the index Lapidus procedure to correct hallux valgus, a foot deformity where the big toe angles outward causing a painful bump. The study assesses the use of the VIRTUGUIDE System along with compatible DePuy Synthes Lapidus implants. This observational study aims to gather detailed information on surgical results and patient health following this specific procedure. Participants will undergo the primary Lapidus procedure using the VIRTUGUIDE System software and instruments and receive compatible DePuy Synthes Lapidus implants. All participants will be followed according to the surgeons standard care for up to 12 months after surgery. The study does not involve additional interventions beyond routine clinical care. During the study, participants will be monitored for up to 12 months post-procedure. Assessments include radiographic documentation of bone fusion and healing, patient-reported outcome measures such as quality of life and pain scores, and tracking of any adverse events related to the device or procedure. Researchers will also record any revisions, reoperations, or recurrences. The study collects data on participants recovery and safety throughout this period.

A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure