Recruiting

VIRTUGUIDE System

Sponsor:

DePuy Synthes Products, Inc.

Code:

NCT07567092

Conditions

Hallux Valgus

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Hallux Valgus

Study ID

NCT07567092

Start date

Jul 7, 2026

Status verified date

Aug, 2026

Completion date

May 15, 2028

Anticipated

Primary completion date

May 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

VIRTUGUIDE System and Compatible DePuy Synthes Lapidus Implant(s)

Participants with hallux valgus undergoing index Lapidus procedure using the VIRTUGUIDE System and compatible DePuy Synthes Lapidus implant(s) will be enrolled in the study. All participants will be followed up as per the surgeon's standard of care for up to 12 months after the surgery.

Primary outcome measure

  • Radiographic Documentation of Fusion/Healing Status [ Time Frame: Up to 12 months post-procedure ]
  • Patient Reported Outcome Measures (PROM): Manchester Oxford Foot Questionnaire (Quality of Life Index) Scores [ Time Frame: Up to 12 months post-procedure ]
  • PROM: Numeric Pain Rating Scale Scores [ Time Frame: Up to 12 months post-procedure ]
  • Number of Participants Reporting any Perioperative Adverse Event (AE) [ Time Frame: Up to 12 months post-procedure ]
  • Number of Participants with AEs Related to Device/Procedure [ Time Frame: Up to 12 months post-procedure ]
  • Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 12 months post-procedure ]
  • Number of Participants Reporting Device Deficiency [ Time Frame: Up to 12 months post-procedure ]
  • Number of Participants who Underwent Revision [ Time Frame: Up to 12 months post-procedure ]
  • Number of Participants who Underwent Reoperation [ Time Frame: Up to 12 months post-procedure ]
  • Number of Participants Reporting Recurrence [ Time Frame: Up to 12 months post-procedure ]

Central Contacts and Locations

Central contacts

Marcie Maichle

443-987-0665MMaichle@ITS.JNJ.com

Priyamvada Devineni

pdevinen@its.jnj.com

Locations

Atlantic Orthopaedic Specialists

Recruiting

Virginia Beach, Virginia, United States, 23462

More Information

Sponsor

DePuy Synthes Products, Inc.

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by DePuy Synthes Products, Inc. on 2026-08-28.