Prospective Study of Minimally Invasive Lapidus Procedure for Hallux Valgus Deformities

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSt. Paul's Hospital, Canada

About this trial

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.

Eligibility criteria

Qualifiers

The subject is at least 19 years of age.

The subject is considered to be skeletally mature.

Soft tissue realignment

Heel cord lengthening

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Minimally invasive lapidus procedure with no arthroscopy
  • Minimally invasive lapidus procedure with arthroscopy

Treatment groups

58 Participants
are divided into 2 treatment groups

Sponsors and collaborators

St. Paul's Hospital, Canada

Lead sponsor

University of British Columbia

Sponsor institution

Stryker Nordic

Collaborator