What is this study trying to find out about hallux valgus?

This study aims to assess the surgeon’s experience and outcomes of the Lapidus procedure using the VIRTUGUIDE System and DePuy Synthes Lapidus implants for hallux valgus correction. It will provide detailed information on surgery results and patient recovery. The study is sponsored by DePuy Synthes Products, Inc.

Who may be eligible for this hallux valgus clinical trial?

Adults aged 22 years or older undergoing a primary Lapidus procedure with the VIRTUGUIDE System and compatible DePuy Synthes implant may be eligible. Participants must understand the patient questionnaires and not have allergies to implant components. Please review eligibility criteria for more details.

Is there any cost to participate in this hallux valgus clinical trial?

Study-related care, including the surgery and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Age: 22Years +

All Genders

ID07567092

Evaluation of the VIRTUGUIDE System and DePuy Synthes Lapidus Implant for Correction of Hallux Valgus Using the Lapidus Procedure

Led by DePuy Synthes Products, Inc. · Updated on 2026-07-31

100

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the surgeon experience and surgery outcomes in participants undergoing the index Lapidus procedure to correct hallux valgus, a foot deformity where the big toe angles outward causing a painful bump. The study assesses the use of the VIRTUGUIDE System along with compatible DePuy Synthes Lapidus implants. This observational study aims to gather detailed information on surgical results and patient health following this specific procedure. Participants will undergo the primary Lapidus procedure using the VIRTUGUIDE System software and instruments and receive compatible DePuy Synthes Lapidus implants. All participants will be followed according to the surgeons standard care for up to 12 months after surgery. The study does not involve additional interventions beyond routine clinical care. During the study, participants will be monitored for up to 12 months post-procedure. Assessments include radiographic documentation of bone fusion and healing, patient-reported outcome measures such as quality of life and pain scores, and tracking of any adverse events related to the device or procedure. Researchers will also record any revisions, reoperations, or recurrences. The study collects data on participants recovery and safety throughout this period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 22Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participants 22 years or older at consent
Undergoing primary Lapidus procedure for hallux valgus using the VIRTUGUIDE System and compatible DePuy Synthes Lapidus implant
Able to read and understand the patient questionnaires in an available language
Use of primary Lapidus fixation implants according to approved labeling
Able to provide informed consent and authorize transfer of information to DePuy Synthes

You will not qualify if you...

Participation in any other medical device or medicinal product study within the previous month (observational studies allowed)
Unable to comply with registry requirements per Principal Investigator
Known allergies to implant components
Undergoing a revision of a Lapidus procedure
Existing hardware in the operative joint

Research Team

Marcie Maichle

Priyamvada Devineni

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