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

NCT07567092 | Not Yet Recruiting

• 1 other identifier: DST202501
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (10)

• Radiographic Documentation of Fusion/Healing Status

  Evaluation of healing, that is, healing will be a combination of radiographic and clinical assessment. Healing (fusion) will be considered achieved based on surgeon interpretation of radiographic images, lack of clinical motion and no pain at the fused site indicative of failed fusion. Imaging, whether X-ray or computed tomography (CT) collected per standard of care (SOC), utilized for radiographic assessment will be collected.

  Up to 12 months post-procedure

• Patient Reported Outcome Measures (PROM): Manchester Oxford Foot Questionnaire (Quality of Life Index) Scores

  The Manchester Oxford Foot Questionnaire (MOxFQ) with three domains (walking/standing, pain, and social interaction) is a standardized instrument developed and validated specifically for hallux valgus (bunions) corrective surgery. It is widely regarded as the gold standard for content and construct validity. It is designed for self (participant) completion and consists of sixteen (16) questions all of which are scored on a five (5) item Likert scale. The scores for each domain range from 0-100, with 100 representing the worst condition.

  Up to 12 months post-procedure

• PROM: Numeric Pain Rating Scale Scores

  The Numeric Pain Rating Scale is a three (3) question self-administered PROM with a 10-point one-dimensional line anchored on either end by verbal descriptors ranging from "no pain" to "worst imaginable pain". The higher score indicates greater pain intensity. The three questions ask the participant to indicate the intensity of current, best, and worst pain levels over the past 24 hours.

  Up to 12 months post-procedure

• Number of Participants Reporting any Perioperative Adverse Event (AE)

  An AE is any untoward medical occurrence (sign, symptom, or disease) in a participant that is deemed at least possibly related to the DePuy Synthes registry device, or any adjunctive implant device used during the index procedure.

  Up to 12 months post-procedure

• Number of Participants with AEs Related to Device/Procedure

  An AE is any untoward medical occurrence (sign, symptom, or disease) in a participant that is deemed at least possibly related to the DePuy Synthes registry device, or any adjunctive implant device used during the index procedure. The determination of whether the AE is related to the device and/or procedure will be based upon whether a causal relationship between the device and/or procedure and the AE is at least a reasonable possibility, i.e., the relationship cannot be ruled out. A causal relationship cannot be ruled out if, in the medical judgment of the Investigator, the effect follows a reasonable temporal association with the use of the device and/or is confirmed by the improvement of the effect upon discontinuation of the clinical use of the device, and/or the effect is not reasonably explained by the participant's clinical state.

  Up to 12 months post-procedure

• Number of Participants with Serious Adverse Events (SAEs)

  SAEs are AEs defined as having one or more of the following outcomes: death, serious deterioration in the health of the subject that has resulted in a. life-threatening illness or injury b. permanent impairment of a body structure or a body function c. hospitalization or prolongation of existing hospitalization d. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function e. chronic disease and Fetal distress, fetal death or a congenital physical or mental impairment or birth defect.

  Up to 12 months post-procedure

• Number of Participants Reporting Device Deficiency

  Device deficiencies include malfunctions, use errors, and inadequate labeling. Device malfunctions are failures of the device to perform as intended and can be defined as issues with software (VIRTUGUIDE Pre-Planning Software), any breakage, malposition, migration, and/or loosening of the device.

  Up to 12 months post-procedure

• Number of Participants who Underwent Revision

  Revision is defined as surgery following the index Lapidus procedure that involves adjustment, modification, removal, or replacement of the implanted device. Surgeries involving adjunctive implants at the first metatarsal-cuneiform joint are considered as a revision.

  Up to 12 months post-procedure

• Number of Participants who Underwent Reoperation

  Reoperation is defined as any subsequent surgical procedure performed following the index surgery that does not involve adjustment, modification, removal, or replacement of the primary Lapidus implant(s), nor the addition of adjunctive fixation at the first metatarsal-cuneiform joint.

  Up to 12 months post-procedure

• Number of Participants Reporting Recurrence

  Radiographic recurrence will be considered to have occurred in those subjects with correction if both of the following criteria are met: Intermetatarsal Angle (IMA) of greater than (\>)12 degree and Hallux Valgus Angle (HVA) \> 15 degree.

  Up to 12 months post-procedure

Study Arms (1)

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.

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DePuy Synthes Products, Inc.: lead

Study Sites (7)

Morrison Community Hospital

Morrison, Illinois, 61270, United States

Location

MercyOne Waterloo Medical Center

Waterloo, Iowa, 50703, United States

Location

The Iowa Clinic

West Des Moines, Iowa, 50266, United States

Location

Foot And Ankle Specialists of Southeast Michigan

Warren, Michigan, 48092, United States

Location

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Atlantic Orthopaedic Specialists

Virginia Beach, Virginia, 23462, United States

Location

MultiCare Good Samaritan Hospital

Puyallup, Washington, 98372, United States

Location

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Officials

• DePuy Synthes Products, Inc. Clinical Trial

  DePuy Synthes Products, Inc.

  STUDY DIRECTOR

Central Study Contacts

Marcie Maichle

CONTACT

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

Priyamvada Devineni

CONTACT

pdevinen@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): May 15, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (7)