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Recruiting NCT07567092

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

— Observational Hallux Valgus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hallux Valgus. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

VIRTUGUIDE™ SYSTEM REGISTRY

Overview

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.

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 8 centers
  • Morrison Community Hospital — Morrison
  • Community Health Network — Indianapolis
  • MercyOne Waterloo Medical Center — Waterloo
  • The Iowa Clinic — West Des Moines
  • Foot And Ankle Specialists of Southeast Michigan — Warren
  • OrthoCarolina Research Institute — Charlotte
  • Atlantic Orthopaedic Specialists — Virginia Beach
  • MultiCare Good Samaritan Hospital — Puyallup

Identifiers

NCT: NCT07567092 · DST202501 · DST202501

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗