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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
The two procedures, with and without arthroscopy, only differ by the method of assessing cartilage removal. Cartilage removal will be assessed arthroscopically in the procedure with arthroscopy. In the procedure without arthroscopy, cartilage removal will be assessed via direct visualization through a mini arthrotomy procedure. After use of the cartilage burr the surgeon will make a small dorsal portal and use this opening to ensure that the cartilage is removed and all debris removed. The incision will be 2 cm long and centered over the dorsal medial aspect of the joint.
After removal of the cartilage with the cartilage burr, a 3.0 arthroscope will be inserted to inspect the joint for all cartilage removal. Any residual cartilage pieces will be removed to ensure complete cartilage debridement from the subchondral bone and fragments removed from the joint.
St. Paul's Hospital
Vancouver, British Columbia, Canada
Primary: Bone Fusion
Rate of bone fusion by comparing the mean percentage of the joint fused at Week 12 using LineUp scans
Time frame: At 12 weeks post-operation
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: At any point during enrolment up to 52 weeks post-operation.
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