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| ID | Type | Description | Link |
|---|---|---|---|
| DST202501 | Other Identifier | DePuy Synthes Products, Inc. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
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Inclusion criteria:
Exclusion criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcie Maichle | Contact | 443-987-0665 | MMaichle@ITS.JNJ.com | |
| Priyamvada Devineni | Contact | pdevinen@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| DePuy Synthes Products, Inc. Clinical Trial | DePuy Synthes Products, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morrison Community Hospital | Withdrawn | Morrison | Illinois | 61270 | United States | |
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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| 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. | 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. | 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. | 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. | 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. | 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. | Up to 12 months post-procedure |
| Community Health Network |
| Not yet recruiting |
| Indianapolis |
| Indiana |
| 46229 |
| United States |
| MercyOne Waterloo Medical Center | Not yet recruiting | Waterloo | Iowa | 50703 | United States |
| The Iowa Clinic | Not yet recruiting | West Des Moines | Iowa | 50266 | United States |
| Foot And Ankle Specialists of Southeast Michigan | Not yet recruiting | Warren | Michigan | 48092 | United States |
| OrthoCarolina Research Institute | Not yet recruiting | Charlotte | North Carolina | 28207 | United States |
| Atlantic Orthopaedic Specialists | Recruiting | Virginia Beach | Virginia | 23462 | United States |
| MultiCare Good Samaritan Hospital | Withdrawn | Puyallup | Washington | 98372 | United States |
| ID | Term |
|---|---|
| D006215 | Hallux Valgus |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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