A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure
Part of paid clinical trials in Morrison, Illinois.
- Sponsor
- DePuy Synthes Products, Inc.
- Study ID
- NCT07567092
- Status
- Not Yet Recruiting
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Conditions
- Hallux Valgus
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- May 15, 2026
- Status verified
- Jun 2026
- Primary completion
- May 15, 2028
- Completion
- May 15, 2028
Study Design
- Enrollment
- 100 participants (estimated)
Arms
- Arm: 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.
Primary Outcome Measure
Radiographic Documentation of Fusion/Healing Status [ Time Frame: Up to 12 months post-procedure ]
Central Contacts
- Marcie Maichle443-987-0665
- Priyamvada Devineni
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Morrison Community Hospital | Morrison | Illinois | 61270 | - |
| Community Health Network | Indianapolis | Indiana | 46229 | - |
| MercyOne Waterloo Medical Center | Waterloo | Iowa | 50703 | - |
| The Iowa Clinic | West Des Moines | Iowa | 50266 | - |
| Foot And Ankle Specialists of Southeast Michigan | Warren | Michigan | 48092 | - |
| OrthoCarolina Research Institute | Charlotte | North Carolina | 28207 | - |
| Atlantic Orthopaedic Specialists | Virginia Beach | Virginia | 23462 | - |
| MultiCare Good Samaritan Hospital | Puyallup | Washington | 98372 | - |
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