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New surgical navigation system for bunions under study

NCT ID NCT07567092

Disease control Sponsor: DePuy Synthes Products, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study will follow 100 adults having bunion correction surgery with the VIRTUGUIDE System, a computer-assisted navigation tool. Researchers will track healing, pain, foot function, and any complications. The goal is to see how well the system works in real-world use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VIRTUGUIDE System (surgical navigation software and instruments) with DePuy Synthes Lapidus implants
What this could lead to
If successful, this registry could show that the VIRTUGUIDE System helps surgeons perform bunion surgery more consistently, potentially leading to better healing and fewer complications.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove the system is better than other methods. Results may not apply to all patients or surgeons.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include adults who will undergo surgical treatment for the correction of hallux valgus via Lapidus procedure using the VIRTUGUIDE System and will receive a compatible DePuy Synthes Lapidus implant.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

The condition(s) this trial relates to.

Hallux Valgus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hallux valgus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlantic Orthopaedic Specialists

    RECRUITING

    Virginia Beach, Virginia, 23462, United States

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