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

27. august 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Virginia
      • Virginia Beach, Virginia, Forenede Stater, 23462
        • Rekruttering
        • Atlantic Orthopaedic Specialists

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Radiographic Documentation of Fusion/Healing Status
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

DePuy Synthes Products, Inc.

Efterforskere

  • Studieleder: DePuy Synthes Products, Inc. Clinical Trial, DePuy Synthes Products, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. juli 2026

Primær færdiggørelse (Anslået)

15. maj 2028

Studieafslutning (Anslået)

15. maj 2028

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

28. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DST202501 (Anden identifikator: DePuy Synthes Products, Inc.)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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