Minimally Invasive Surgery for Bunions

Overseen By Alastair Younger

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Paul's Hospital, Canada

Disqualifiers: Arthritis, Severe osteoporosis, Neuromuscular, others

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

Compensation: Varies

Number of Visits: 3

Duration: Immediate (surgical procedure)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to fix bunions using minimally invasive surgery, specifically the Minimally Invasive Lapidus Procedure. It compares two techniques for checking cartilage during the procedure: using a mini camera (arthroscopy) or making a small cut (mini arthrotomy). The trial evaluates bone healing and patient recovery after surgery. It seeks participants with bunions who plan to undergo this specific surgery. Participants must follow post-surgery appointments and care instructions. As an unphased trial, this study allows patients to contribute to innovative surgical techniques that could enhance future bunion treatments.

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 prior data suggests that this minimally invasive surgery is safe for correcting bunions?

Research shows that minimally invasive surgery (MIS) for the Lapidus procedure, which corrects bunions, is gaining popularity due to faster recovery and less pain. Studies have shown that patients undergoing MIS for bunions tend to heal quicker and can walk on their foot sooner than those who have traditional open surgery.

Regarding safety, the MIS approach is generally well-received. One study found that out of 301 feet treated with MIS, only about 26.6% required additional surgery to address the issue. While most patients do well, some might need further treatment.

The new trial examines two methods for removing cartilage during the procedure. One method uses a small camera (arthroscopy), while the other involves a small incision to inspect the joint. Both aim to ensure proper cartilage removal, crucial for bone healing.

Overall, current studies consider the MIS Lapidus procedure safe. However, as this trial tests new methods, it is important to monitor the results once available. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for minimally invasive surgery for bunions because it explores a potentially faster and easier surgical method. The trial is comparing the standard method, which uses arthroscopy, with a new technique called the Non-Arthroscopic Mini Arthrotomy Procedure. This new approach involves making a small incision for cartilage and debris removal without using arthroscopy, which could simplify the operation. If this method proves to be as effective as the traditional one, it could lead to quicker procedures and recovery times for patients suffering from bunions.

What evidence suggests that this trial's procedures could be effective for correcting bunions?

Studies have shown that the minimally invasive Lapidus procedure effectively corrects bunions, also known as hallux valgus deformities. Research indicates that this method leads to better patient-reported outcomes compared to traditional methods. In this trial, participants will be assigned to one of two treatment arms: the Arthroscopy arm, which uses the current standard of care with a new screw (PROstep MIS 5mm Chamfer Screw), or the No Arthroscopy arm, which involves a Non-Arthroscopic Mini Arthrotomy Procedure. Patients typically have a lower risk of non-union and experience fewer issues with surgical hardware. Evidence also suggests that recovery times are shorter, allowing for a quicker return to normal activities. Overall, the minimally invasive Lapidus procedure appears promising for treating bunions with less downtime and fewer complications. ^{1 2 4 6 7}

Who Is on the Research Team?

Alastair Younger

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

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

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

The subject is able to provide informed consent

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: No Arthroscopy Experimental Treatment 1 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: Arthroscopy Active Control 1 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.

Who Is Running the Clinical Trial?

St. Paul's Hospital, Canada

Lead Sponsor

Trials

48

Recruited

13,200+

Stryker Nordic

Industry Sponsor

Trials

35

Recruited

4,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11015780/

Modified Lapidus vs Minimally Invasive Techniques - PMC MISDTO was found to improve patient reported outcomes significantly more than MLP, with a lower non-union rate, lower hardware failure rate, and shorter time ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06570590

Prospective Study of Minimally Invasive Lapidus Procedure ... The Lapidus procedure corrects bunions, a condition called hallux first ray deformity. Using minimally invasive surgery (MIS) to perform this procedure on ...

3. ctv.veeva.com ctv.veeva.com/study/prospective-study-of-minimally-invasive-lapidus-procedure-for-hallux-valgus-deformities

Prospective Study of Minimally Invasive Lapidus Procedure for ... 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 ...

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/2473011424S00206

Comparison of Minimally Invasive and Open Bunion ... Minimally invasive bunionectomy (MIS) has gained popularity, namely due to evidence showing reduced recovery time, earlier weight-bearing, and less post- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9771687/

A Systematic Review of Open and Minimally Invasive ... Out of 301 feet, 80 (26.6%) underwent revision with MIS techniques (involving distal metatarsal osteotomies). Those undergoing grouped MIS ...

6. withpower.com withpower.com/trial/phase-bunion-9-2024-096ef

Minimally Invasive Surgery for Bunions · Info for Participants Research shows that minimally invasive approaches to bunion correction, including the Lapidus procedure, have gained popularity due to positive outcomes, such ...

7. link.springer.com link.springer.com/article/10.1007/s00590-024-04074-7

Clinical and radiological outcome of surgical hallux valgus ... MI surgery patients showed significantly more significant improvements in AOFAS scores compared to the open surgery group (t test: t = 12.454, ...