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NCT07567092Recruiting

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

DePuy Synthes Products, Inc.

Start Date

7/7/2026

Completion Date

5/15/2028

Summary

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.

Eligibility Criteria

Age Range: 22 years to No maximum

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

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Conditions

Hallux Valgus

Locations

Morrison Community Hospital

Morrison, Illinois 61270

United States

Community Health Network

Indianapolis, Indiana 46229

United States

MercyOne Waterloo Medical Center

Waterloo, Iowa 50703

United States

The Iowa Clinic

West Des Moines, Iowa 50266

United States

Foot And Ankle Specialists of Southeast Michigan

Warren, Michigan 48092

United States

OrthoCarolina Research Institute

Charlotte, North Carolina 28207

United States

Atlantic Orthopaedic Specialists

Virginia Beach, Virginia 23462

United States

MultiCare Good Samaritan Hospital

Puyallup, Washington 98372

United States