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

27 août 2026 mis à jour par: DePuy Synthes Products, Inc.

VIRTUGUIDE™ SYSTEM REGISTRY

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

100

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • Virginia
      • Virginia Beach, Virginia, États-Unis, 23462
        • Recrutement
        • Atlantic Orthopaedic Specialists

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Radiographic Documentation of Fusion/Healing Status
Délai: Up to 12 months post-procedure
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
Délai: Up to 12 months post-procedure
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
Délai: Up to 12 months post-procedure
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)
Délai: Up to 12 months post-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.
Up to 12 months post-procedure
Number of Participants with AEs Related to Device/Procedure
Délai: Up to 12 months post-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)
Délai: Up to 12 months post-procedure
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
Délai: Up to 12 months post-procedure
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
Délai: Up to 12 months post-procedure
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
Délai: Up to 12 months post-procedure
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
Délai: Up to 12 months post-procedure
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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

DePuy Synthes Products, Inc.

Les enquêteurs

  • Directeur d'études: DePuy Synthes Products, Inc. Clinical Trial, DePuy Synthes Products, Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

7 juillet 2026

Achèvement primaire (Estimé)

15 mai 2028

Achèvement de l'étude (Estimé)

15 mai 2028

Dates d'inscription aux études

Première soumission

28 avril 2026

Première soumission répondant aux critères de contrôle qualité

28 avril 2026

Première publication (Réel)

5 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • DST202501 (Autre identifiant: DePuy Synthes Products, Inc.)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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