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

ConditionHallux Valgus
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorDePuy Synthes Products, Inc.

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

100 Participants
are grouped into 1 trial group

Sponsors and collaborators