A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus… (NCT07567092) | Clinical Trial Compass
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A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure
United States100 participantsStarted 2026-05-15
Plain-language 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.
Who can participate
Age range22 Years
SexALL
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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
What they're measuring
1
Radiographic Documentation of Fusion/Healing Status
Timeframe: Up to 12 months post-procedure
2
Patient Reported Outcome Measures (PROM): Manchester Oxford Foot Questionnaire (Quality of Life Index) Scores
Timeframe: Up to 12 months post-procedure
3
PROM: Numeric Pain Rating Scale Scores
Timeframe: Up to 12 months post-procedure
4
Number of Participants Reporting any Perioperative Adverse Event (AE)
Timeframe: Up to 12 months post-procedure
5
Number of Participants with AEs Related to Device/Procedure
Timeframe: Up to 12 months post-procedure
6
Number of Participants with Serious Adverse Events (SAEs)
Timeframe: Up to 12 months post-procedure
7
Number of Participants Reporting Device Deficiency