Prospective Study of Minimally Invasive Lapidus Procedure for Hallux Valgus Deformities

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.

Conditions

• Hallux Valgus and Bunion

Interventions

PROCEDURE

Minimally invasive lapidus procedure with no arthroscopy

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.

PROCEDURE

Minimally invasive lapidus procedure with arthroscopy

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.

Sponsors & Collaborators

• Stryker Nordic

  collaborator INDUSTRY

• St. Paul's Hospital, Canada

  lead OTHER

Principal Investigators

• Alastair Younger · University of British Columbia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2026-10-01

Completion

2027-05-01

FDA Device

Yes

Countries

• Canada

Study Locations