Prospective Study of Minimally Invasive Lapidus Procedure for Hallux Valgus Deformities (NCT06570590) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prospective Study of Minimally Invasive Lapidus Procedure for Hallux Valgus Deformities
Canada58 participantsStarted 2024-10-01
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The subject is at least 19 years of age.
* The subject is considered to be skeletally mature.
* The subject is undergoing an isolated 1st TMT, which may or may not include concomitant procedures, such as:
* Soft tissue realignment
* Heel cord lengthening
* Akin osteotomy
* Lesser toe osteotomies or claw toe correction
* The subject is able to comply with all post-operative evaluations and visits.
* The subject is able to provide informed consent.
* The subject consents to and will receive either arthroscopy or no arthroscopy condition using the PROstep MIS 5mm Chamfer Screw.
Exclusion Criteria:
* 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.
* The subject has:
* Arthritis in the affected joint
* Severe osteoporosis
* Neuromuscular impairment
* Prior or current infection in the affected joint
* Charcot foot
* The subject has undergone previous fusion surgery of the proposed site (i.e., revision of failed fusion attempt).
* The subject will be undergoing an ankle replacement, any other concomitant fusion(s), or any lesser metatarsal osteotomies in the affected foot or ankle in the same sitting.
* The subject has concomitant injury, which in the opinion of the Investigator, is likely to impair functions for as long as or longer than the recovery from the subject's 1st TMT fus…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.