Hallux ValgusNCT07567092
A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure
An observational study of Hallux Valgus, run by DePuy Synthes Products, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Hallux Valgus
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2026to 15 May 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Priyamvada Devineni contact
United States1 site, 1 recruiting
- Recruiting
Atlantic Orthopaedic Specialists
Virginia Beach, Virginia, 23462
About this study
Official title: 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.
- Conditions
- Hallux Valgus
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start7 Jul 2026
- Primary completion15 May 2028 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- DePuy Synthes Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- DePuy Synthes Products, Inc. Clinical Trial, Study director, DePuy Synthes Products, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567092
- Sponsor's protocol ID
- DST202501
- Other IDs
- DST202501
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIRTUGUIDE™ SYSTEM REGISTRY
- ClinicalTrials.gov ID
- NCT07567092
- Acronym / sponsor ID
- DST202501
- Conditions
- Hallux Valgus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- DePuy Synthes Products, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiographic Documentation of Fusion/Healing Status
Time frame: 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.
Patient Reported Outcome Measures (PROM): Manchester Oxford Foot Questionnaire (Quality of Life Index) Scores
Time frame: 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.
PROM: Numeric Pain Rating Scale Scores
Time frame: 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.
Number of Participants Reporting any Perioperative Adverse Event (AE)
Time frame: 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.
Number of Participants with AEs Related to Device/Procedure
Time frame: 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.
Number of Participants with Serious Adverse Events (SAEs)
Time frame: 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.
Number of Participants Reporting Device Deficiency
Time frame: 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.
Number of Participants who Underwent Revision
Time frame: 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.
Number of Participants who Underwent Reoperation
Time frame: 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.
Number of Participants Reporting Recurrence
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Priyamvada Devineni contact
DePuy Synthes Products, Inc. Clinical Trial study director
DePuy Synthes Products, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Valgus, run by DePuy Synthes Products, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcie Maichle (443-987-0665, MMaichle@ITS.JNJ.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Documentation of Fusion/Healing Status (time frame: Up to 12 months post-procedure). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.