A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure
VIRTUGUIDE™ SYSTEM REGISTRY
- Hallux Valgus
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- DePuy Synthes Products, Inc.
- Enrolment target
- 100
- Started
- 7 July 2026
- Main results due
- 15 May 2028
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Aged 22 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the 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.
Study sites(1)
Atlantic Orthopaedic Specialists
Virginia Beach, Virginia, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07567092. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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