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.
The subject is at least 19 years of age.
The subject is considered to be skeletally mature.
Soft tissue realignment
Heel cord lengthening
Patients indicated for TMT fusion for non-hallux valgus procedures.
Patients with simultaneous fusion of second and third ray.
Patients indicated for navicular-cuneiform joint performed at the same time.
Arthritis in the affected joint
Parallel
Minimally invasive lapidus procedure with no arthroscopy
Procedure/SurgeryThe 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.
Minimally invasive lapidus procedure with arthroscopy
Procedure/SurgeryAfter 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.
Primary: Bone Fusion
Rate of bone fusion by comparing the mean percentage of the joint fused at Week 12 using LineUp scans
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.
Secondary: Questionnaires-Foot and Ankle Ability Measure (FAAM)
Patient reported outcomes as measured by FAAM compared to baseline questionnaire.
Secondary: Questionnaires-Pain Catastrophizing Scale (PCS)
Patient reported outcomes as measured by PCS compared to baseline questionnaire.
Secondary: Re-operation and complication rates
Reoperations and complications will be recorded
Click on the lead sponsor to view all of their trials.
St. Paul's Hospital, Canada
Lead sponsor
University of British Columbia
Sponsor institution
Stryker Nordic
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
