Hallux Valgus
Conditions
Brief 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 VIRTUGUIDE System and compatible DePuy Synthes Lapidus implants.
Interventions
None listed
Sponsors
DePuy Synthes Products, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Documentation of Fusion/Healing Status | 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 | 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 | 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) | 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 | 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) | 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 | 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 | 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 | 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 | 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. |
Countries
United States
Contacts
CONTACTMarcie Maichle
CONTACTPriyamvada Devineni
STUDY_DIRECTORDePuy Synthes Products, Inc. Clinical Trial
DePuy Synthes Products, Inc.
Outcome results
None listed