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
Recruiting

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

First listed
May 5, 2026
Start date
Jul 10, 2026
Status verified
Jul 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

Locations (8)

FacilityCityStateZIPSite coordinators
Morrison Community HospitalMorrisonIllinois61270-
Community Health NetworkIndianapolisIndiana46229-
MercyOne Waterloo Medical CenterWaterlooIowa50703-
The Iowa ClinicWest Des MoinesIowa50266-
Foot And Ankle Specialists of Southeast MichiganWarrenMichigan48092-
OrthoCarolina Research InstituteCharlotteNorth Carolina28207-
Atlantic Orthopaedic SpecialistsVirginia BeachVirginia23462-
MultiCare Good Samaritan HospitalPuyallupWashington98372-

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