A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure
27 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
De observación
Inscripción (Estimado)
100
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Marcie Maichle
- Número de teléfono: 443-987-0665
- Correo electrónico: MMaichle@ITS.JNJ.com
Copia de seguridad de contactos de estudio
- Nombre: Priyamvada Devineni
- Correo electrónico: pdevinen@its.jnj.com
Ubicaciones de estudio
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Virginia
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Virginia Beach, Virginia, Estados Unidos, 23462
- Reclutamiento
- Atlantic Orthopaedic Specialists
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Radiographic Documentation of Fusion/Healing Status
Periodo de tiempo: Up to 12 months post-procedure
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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.
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Up to 12 months post-procedure
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Patient Reported Outcome Measures (PROM): Manchester Oxford Foot Questionnaire (Quality of Life Index) Scores
Periodo de tiempo: Up to 12 months post-procedure
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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.
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Up to 12 months post-procedure
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PROM: Numeric Pain Rating Scale Scores
Periodo de tiempo: Up to 12 months post-procedure
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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.
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Up to 12 months post-procedure
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Number of Participants Reporting any Perioperative Adverse Event (AE)
Periodo de tiempo: Up to 12 months post-procedure
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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.
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Up to 12 months post-procedure
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Number of Participants with AEs Related to Device/Procedure
Periodo de tiempo: Up to 12 months post-procedure
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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.
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Up to 12 months post-procedure
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Number of Participants with Serious Adverse Events (SAEs)
Periodo de tiempo: Up to 12 months post-procedure
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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.
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Up to 12 months post-procedure
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Number of Participants Reporting Device Deficiency
Periodo de tiempo: Up to 12 months post-procedure
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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.
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Up to 12 months post-procedure
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Number of Participants who Underwent Revision
Periodo de tiempo: Up to 12 months post-procedure
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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.
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Up to 12 months post-procedure
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Number of Participants who Underwent Reoperation
Periodo de tiempo: Up to 12 months post-procedure
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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.
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Up to 12 months post-procedure
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Number of Participants Reporting Recurrence
Periodo de tiempo: Up to 12 months post-procedure
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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.
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Up to 12 months post-procedure
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: DePuy Synthes Products, Inc. Clinical Trial, DePuy Synthes Products, Inc.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
7 de julio de 2026
Finalización primaria (Estimado)
15 de mayo de 2028
Finalización del estudio (Estimado)
15 de mayo de 2028
Fechas de registro del estudio
Enviado por primera vez
28 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de abril de 2026
Publicado por primera vez (Actual)
5 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- DST202501 (Otro identificador: DePuy Synthes Products, Inc.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .