VIRTUGUIDE System with DePuy Synthes Lapidus Implant for Hallux Valgus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates surgeon experience and surgical outcomes when using the VIRTUGUIDE System (software and instruments) together with a compatible DePuy Synthes Lapidus implant during the index Lapidus procedure for hallux valgus. Eligible participants are adults 22 years or older undergoing a primary Lapidus correction and who can complete translated patient-reported outcome measures. The study collects on-label fixation implants and may include data transfer to DePuy Synthes. No interventional treatment beyond standard care is described, and the focus is on real-world performance and outcomes. Participating sites include three midwestern and regional foot and ankle centers in the United States.

Why it matters

Who can join: the full rules

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

Where it's running

• MercyOne Waterloo Medical Center
  Waterloo, Iowa, United States Recruiting
• The Iowa Clinic
  West Des Moines, Iowa, United States Recruiting
• Foot And Ankle Specialists of Southeast Michigan
  Warren, Michigan, United States Recruiting
• OrthoCarolina Research Institute
  Charlotte, North Carolina, United States Recruiting
• Atlantic Orthopaedic Specialists
  Virginia Beach, Virginia, United States Recruiting

Study contacts

• Study coordinator: Marcie Maichle
• Email: MMaichle@ITS.JNJ.com
• Phone: 443-987-0665

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.