Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant for Hallux Valgus
This study is looking at the VIRTUGUIDE System and DePuy Synthes Lapidus implants for people having surgery for hallux valgus (a foot deformity where the big toe angles outward, causing a painful bump). Researchers want to understand the surgeon's experience and how well patients recover after the procedure. You might be able to join if you are at least 22 years old and are having a primary Lapidus procedure using these specific tools and implants. The study will measure how well your foot heals and your pain and quality of life for up to 12 months after surgery. The current status of this study is unclear, and it plans to enroll 100 participants.
- Study design
- This is an observational study, meaning researchers will watch and collect information without providing a specific treatment. It plans to include 100 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 12 months after their procedure to check on healing, pain, and quality of life.
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A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- DePuy Synthes Products, Inc. Clinical Trial · STUDY_DIRECTOR · DePuy Synthes Products, Inc.
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Radiographic Documentation of Fusion/Healing StatusUp 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) ScoresUp 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 ScoresUp 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)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/ProcedureUp 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)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 DeficiencyUp 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 RevisionUp 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 ReoperationUp 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 RecurrenceUp 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.