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

VIRTUGUIDE™ SYSTEM REGISTRY

The purpose of this study is to assess the surgeon experience and surgery outcomes in participants undergoing index Lapidus procedure for the correction of hallux valgus (a foot deformity where the big toe angles outward towards the other toes, causing a painful bony bump at the base of the big toe joint) using the VIRTUGUIDE System and compatible DePuy Synthes Lapidus implants.

Inclusion criteria:

• Participants, both male and female, >= 22 years old at the time of consent
• Participants undergoing a primary Lapidus procedure for the correction of hallux valgus using the VIRTUGUIDE System (software + instruments) and who receive a compatible DePuy Synthes Lapidus implant
• Participants must be able to read and understand questions and responses in an available translated language for patient reported outcomes (PROMs)
• All primary Lapidus fixation implants are used on-label according to the implant IFU/FDA cleared labeling
• Participants who can speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and are willing and able to provide informed patient consent for participation and have authorized the transfer of his/her information to DePuy Synthes

Exclusion criteria:

• Participation in any other medical device or medicinal product study within the previous month. Participation in observational studies is allowed
• In the opinion of the Principal Investigator, the subject is unable to comply with the requirements of the registry
• Participant has known allergies to implant components
• Participant presenting for a revision of a Lapidus procedure
• Participant has existing hardware in the operative joint