Prospective Study of Minimally Invasive Lapidus Procedure for Hallux Valgus Deformities
NCT Number: NCT06570590
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hallux Valgus and Bunion
Interventions: PROCEDURE: Minimally invasive lapidus procedure with no arthroscopy|PROCEDURE: Minimally invasive lapidus procedure with arthroscopy
Sponsor: St. Paul's Hospital, Canada
Collaborators: Stryker Nordic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 58
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2027-05-01
Locations: St. Paul's Hospital, Vancouver, British Columbia, V6Z 1Y6, Canada

Summary:
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.

Primary Outcome Measures: Primary: Bone Fusion, Rate of bone fusion by comparing the mean percentage of the joint fused at Week 12 using LineUp scans, At 12 weeks post-operation
Secondary Outcome Measures: Secondary: Questionnaires-Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS), Patient reported outcomes as measured by MODEMS (includes AOS and SF-36) compared to baseline questionnaire., Pre-operative, and at all post-operative followups (2 Weeks, 6 Weeks, 12 Weeks, 52 Weeks)|Secondary: Questionnaires-Foot and Ankle Ability Measure (FAAM), Patient reported outcomes as measured by FAAM compared to baseline questionnaire., Pre-operative, and at all post-operative followups (2 Weeks, 6 Weeks, 12 Weeks, 52 Weeks)|Secondary: Questionnaires-Pain Catastrophizing Scale (PCS), Patient reported outcomes as measured by PCS compared to baseline questionnaire., Pre-operative, and at all post-operative followups (2 Weeks, 6 Weeks, 12 Weeks, 52 Weeks)|Secondary: Re-operation and complication rates, Reoperations and complications will be recorded, At any point during enrolment up to 52 weeks post-operation.