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

Recruiting now

Conditions studied: Hallux Valgus

In brief

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.

Key facts

Study ID

NCT07567092

Run by

DePuy Synthes Products, Inc.

People needed

100

Starts

2026-07-07

Expected to finish

2028-05-15

Last updated by the study team

2026-07-31

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Atlantic Orthopaedic Specialists — Virginia Beach, Virginia, United States (enrolling)
• Community Health Network — Indianapolis, Indiana, United States
• MercyOne Waterloo Medical Center — Waterloo, Iowa, United States
• The Iowa Clinic — West Des Moines, Iowa, United States
• Foot And Ankle Specialists of Southeast Michigan — Warren, Michigan, United States
• OrthoCarolina Research Institute — Charlotte, North Carolina, United States
• Morrison Community Hospital — Morrison, Illinois, United States
• MultiCare Good Samaritan Hospital — Puyallup, Washington, United States

Full record on ClinicalTrials.gov

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