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Compensation: Varies

Number of Visits: 3

Duration: Immediate (surgical procedure)

58 Participants Needed

Minimally Invasive Surgery for Bunions

Overseen ByAlastair Younger

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Paul's Hospital, Canada

Disqualifiers: Arthritis, Severe osteoporosis, Neuromuscular, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of 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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment Minimally Invasive Lapidus Procedure for bunions?

Research shows that minimally invasive approaches to bunion correction, including the Lapidus procedure, have gained popularity due to positive outcomes, such as less pain and faster healing. A study on the modified Lapidus procedure for adolescent bunions reported excellent or good results in 91% of patients, indicating its effectiveness in treating bunion deformities.¹ ² ³ ⁴ ⁵

How is the Minimally Invasive Lapidus Procedure different from other treatments for bunions?

The Minimally Invasive Lapidus Procedure is unique because it uses a minimally invasive approach to correct severe bunion deformities, which typically require open surgery. This method involves smaller incisions, potentially leading to less pain, quicker recovery, and fewer complications compared to traditional open surgeries.¹ ² ³ ⁶ ⁷

Research Team

Alastair Younger

Principal Investigator

University of British Columbia

Eligibility Criteria

This trial is for patients with bunions, specifically hallux valgus deformity. It's suitable for those interested in minimally invasive surgery to correct the condition and willing to provide feedback through questionnaires about their outcomes.

Inclusion Criteria

The subject is able to comply with all post-operative evaluations and visits

The subject is able to provide informed consent

I agree to undergo a procedure with the PROstep screw, either with or without arthroscopy.

See 3 more

Exclusion Criteria

I have bone issues near the fusion site that could affect healing.

My BMI is over 50 kg/m2, classifying me as morbidly obese.

I have arthritis in one of my joints.

See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the minimally invasive Lapidus procedure with either arthroscopy or mini arthrotomy for cartilage removal

Immediate (surgical procedure)

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for bone fusion and patient-reported outcomes at various intervals

52 weeks

Follow-ups at 2, 6, 12, and 52 weeks

Long-term Follow-up

Participants are monitored for re-operation and complication rates

Up to 52 weeks

Treatment Details

Interventions

Minimally Invasive Lapidus Procedure

Trial Overview The study compares two types of minimally invasive Lapidus procedures: one using a mini camera (arthroscopy) and the other without it. The focus is on bone healing at 12 weeks post-op, patient satisfaction, re-operation rates, and how well the bunion correction holds up on imaging tests.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: No ArthroscopyExperimental Treatment1 Intervention

Non-Arthroscopic Mini Arthrotomy Procedure (research-specific): Surgical procedure between the two treatment groups are equivalent except at the step of checking cartilage removal. After use of the cartilage burr the surgeon will make a small dorsal portal and use this 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. The Principal Investigator wants to know if the mini arthrotomy procedure is as effective as the control because this procedure is faster and easier to perform.

Group II: ArthroscopyActive Control1 Intervention

Using arthroscopy in minimally invasive lapidus procedure is the current standard of care. However a new screw is used (PROstep MIS 5mm Chamfer Screw). The new hardware is expected to be substantially equivalent to standard of care.