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Prospective Study of Minimally Invasive Lapidus Procedure for Hallux Valgus Deformities

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated August 26, 2024 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
The Lapidus procedure corrects bunions, a condition called hallux first ray deformity. Using minimally invasive surgery (MIS) to perform this procedure on patients with hallux valgus deformity is a newer approach. Because it's newer, there is not studies on how patients feel about it directly through patient reported outcomes (PROMs), which involve patients filling out questionnaires. Previous studies have looked at information that could be gathered from radiographs. This study looks specifically at how well bones heal after the MIS procedure and how patients feel about it based on their recorded responses in PROMs. The Lapidus procedure involves a step where the surgeon checks for the amount of cartilage removal, which can be done by inserting a mini camera into the joint (arthroscopically) or through a small incision for visual inspection. These two methods of checking cartilage removal are the two treatment groups for this study that patients are randomly assigned to. The main goals of the study are as follows: * To determine healing in minimally invasive Lapidus. Evaluated by bones fusing together at 12 weeks post-operation. * To determine patient reported outcomes following Lapidus procedures * To determine the relationship between patient-reported outcomes and percent bone healing. * To assess the nonunion (bone not fusing together) rate and re-operation rate following Lapidus procedures * To assess the correction achieved on radiographic and standing CT measurements. * To compare radiographic and Standing CT assessment of hallux valgus deformity and correction after surgery.
Trial Details
NCT Number NCT06570590
Lead Sponsor St. Paul's Hospital, Canada
Collaborators: Stryker Nordic
Conditions
(from sponsor)
Hallux Valgus and Bunion
Related terms Bunion, Hallux Valgus
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov