Lateral Soft Tissue Release for Bunions

Overseen By Haley M Goble, MHA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Methodist Hospital Research Institute

Disqualifiers: Connective tissue disease, severe bunions, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding a lateral soft tissue release (LSTR) to a common bunion surgery, known as Chevron osteotomy, improves foot alignment without additional complications. Participants will be divided into two groups: one will undergo the standard surgery, while the other will receive the surgery with the added LSTR step. The trial aims to determine which method offers better correction for bunions. It seeks individuals over 18 with mild to moderate bunions that may benefit from the surgery. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

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

What prior data suggests that this surgical technique is safe for bunion correction?

Research shows that adding a lateral soft tissue release (LSTR) to Chevron osteotomy, a common bunion surgery, is generally safe. Studies on this combination have shown mixed benefits, but no major reports of serious side effects from the LSTR procedure itself have emerged. This indicates that patients usually tolerate it well. Surgeons have performed this surgery for a long time, and while earlier reports mentioned possible complications, these are rare. Therefore, patients considering joining the trial can feel reassured about the procedure's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Chevron osteotomy with lateral soft tissue release (LSTR) for bunions because it adds a new dimension to the standard surgical approach. Most bunion surgeries, like the traditional Chevron osteotomy, primarily focus on bone realignment. However, the addition of LSTR targets the soft tissue structures, which may help in better correcting the bunion deformity and potentially reducing recurrence rates. By addressing both bone and soft tissue, this method could offer improved outcomes for patients, making it a promising advancement in bunion treatment.

What evidence suggests that a lateral soft tissue release is effective for bunion correction?

This trial will compare the outcomes of Chevron osteotomy bunion surgery with and without lateral soft tissue release (LSTR). Research has shown that combining a Chevron osteotomy with LSTR can lead to positive outcomes for bunion correction, particularly in cases of moderate to severe hallux valgus, where the big toe points inward. Some studies suggest this combination might improve the alignment of the big toe and the space between the first and second toe bones more effectively than a Chevron osteotomy alone. However, results vary, with some research showing benefits and others showing little difference. The treatment aims to straighten the big toe and reduce pain by addressing the soft tissue around the joint. Overall, this approach is being evaluated for its potential to improve surgical results without adding complications. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with mild to moderate bunions. Participants must be able to consent and are selected by study physicians as candidates for Chevron osteotomy, a type of foot surgery. People who don't meet the specific medical criteria or can't follow the trial procedures will be excluded.

Inclusion Criteria

I am over 18 years old.

I have bunions that can be treated with a specific type of surgery.

Exclusion Criteria

History of connective tissue disease

Presence of juvenile bunions

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Chevron osteotomy bunion surgery with or without lateral soft tissue release (LSTR)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, with surveys and x-rays at 3, 6, and 12 months

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Chevron Osteotomy with Lateral Soft Tissue Release

Trial Overview

The study tests if adding lateral soft tissue release (LSTR) to Chevron osteotomy bunion surgery leads to better correction of the bunion angles without extra complications. Patients are randomly assigned to receive either standard surgery or surgery with LSTR and followed up with surveys and x-rays.

How Is the Trial Designed?

Group I: Chevron osteotomy bunion surgery with LSTR Experimental Treatment 1 Intervention

Participants randomized to this group will receive a Chevron osteotomy bunion surgery and a lateral soft tissue release.

Group II: Chevron osteotomy bunion surgery without LSTR Active Control 1 Intervention

Participants randomized to this group will receive a standard Chevron osteotomy bunion surgery.

Chevron Osteotomy with Lateral Soft Tissue Release is already approved in United States, European Union for the following indications:

Approved in United States as Chevron Osteotomy with LSTR for:

• Mild to moderate bunions

Approved in European Union as Chevron Osteotomy with LSTR for:

• Hallux valgus deformity
• Mild to moderate bunions

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Published Research Related to This Trial

In a study of 48 feet from 43 patients with mild to moderate hallux valgus, distal chevron osteotomy combined with selective lateral soft tissue release resulted in greater correction of the hallux valgus angle (19.1 degrees) compared to osteotomy alone (12.8 degrees).

Both surgical approaches led to significant improvements in patient satisfaction and AOFAS scores, with the combined approach showing a slightly higher average improvement (31.8 points) compared to the osteotomy alone (29.2 points), indicating effective and safe treatment options for hallux valgus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of intraoperative varus stress test for lateral soft tissue release during chevron bunion procedure. Kim, HN., Suh, DH., Hwang, PS., et al.[2014]

In a study involving 41 patients with moderate hallux valgus, both distal Chevron metatarsal osteotomy (DCMO) and DCMO with lateral soft-tissue release (LSTR) improved the hallux valgus angle, but the addition of LSTR led to better patient satisfaction and improved medial sesamoid bone position.

The findings suggest that while both surgical approaches are effective, DCMO combined with LSTR may offer enhanced outcomes, making it a preferable option for treating moderate hallux valgus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Treatment of Moderate Hallux Valgus: A Comparison of Distal Chevron Metatarsal Osteotomy With and Without Lateral Soft-Tissue Release. Grle, M., Vrgoc, G., Bohacek, I., et al.[2018]

In a study of 56 feet from 51 patients with moderate to severe hallux valgus, distal chevron osteotomy combined with lateral soft tissue release significantly improved foot alignment, with the hallux abductus angle decreasing from 33.5° to 11.6° and the first intermetatarsal angle from 16.4° to 9.7° over an average follow-up of 27.5 months.

The procedure resulted in high patient satisfaction, with 90% of patients reporting they were very satisfied or satisfied with the outcome, and no cases of deformity recurrence or osteonecrosis of the metatarsal head were observed, indicating both safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distal chevron osteotomy with lateral soft tissue release for moderate to severe hallux valgus decided using intraoperative varus stress radiographs. Kim, HN., Park, YJ., Kim, GL., et al.[2016]

In a study of 86 patients with hallux valgus deformities, the addition of lateral soft tissue release during distal chevron osteotomy did not significantly improve clinical or radiographic outcomes compared to surgery without it.

Patients who underwent the lateral soft tissue release experienced a significantly reduced range of motion in the first metatarsophalangeal joint and reported complications such as digital neuritis and unsatisfactory scarring, suggesting that this procedure may not be necessary for mild to moderate cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of distal chevron osteotomy with and without lateral soft tissue release for the treatment of hallux valgus. Lee, HJ., Chung, JW., Chu, IT., et al.[2016]

In a study of 138 patients undergoing distal chevron metatarsal osteotomy for hallux valgus, both conventional open lateral soft tissue release (OLSTR) and transarticular lateral soft tissue release (TLSTR) showed similar clinical and radiographic outcomes after a mean follow-up of 26 months.

However, OLSTR was associated with a higher incidence of first metatarsophalangeal joint stiffness, while TLSTR had a tendency towards post-operative hallux varus, indicating that the choice of technique may influence specific complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of open lateral release and transarticular lateral release in distal chevron metatarsal osteotomy for hallux valgus correction. Ahn, JY., Lee, HS., Chun, H., et al.[2021]

In a study of 119 feet from 90 patients with hallux valgus, lateral soft tissue release (LSTR) did not significantly change the position of the fibular sesamoid compared to surgery without LSTR, indicating that LSTR may not impact sesamoid alignment as intended.

Both groups showed improved clinical and radiologic outcomes post-surgery, but the complication rates were similar, suggesting that LSTR does not provide additional benefits in terms of sesamoid positioning or safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Lateral Soft Tissue Release on Sesamoid Position in Hallux Valgus Surgery. Woo, K., Yu, IS., Kim, JH., et al.[2016]

The modified chevron osteotomy combined with distal soft tissue reconstruction effectively treated high-grade bunionette deformity in 26 patients, showing significant improvements in foot angles and overall function after surgery.

No postoperative complications such as infections or nonunion were reported, and patients experienced high satisfaction with their outcomes, as indicated by a significant increase in the AOFAS score from pre-operative to post-operative assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Modified Chevron osteotomy combined distal soft tissue reconstruction to treat high-grade bunionette deformity]. Feng, SM., Wang, AG., Ding, P., et al.[2018]

A systematic review of six studies involving 425 patients showed that lateral soft tissue release (LSTR) combined with osteotomy for hallux valgus (HV) significantly improved the correction of the hallux valgus angle (HVA), especially when the lateral sesamoido-metatarsal ligament was released.

The study also indicated a moderate improvement in the inter-metatarsal angle (IMA) with LSTR, suggesting that this technique may enhance surgical outcomes for patients with moderate to severe HV deformities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of comparative clinical studies of isolated osteotomy versus osteotomy with lateral soft tissue release in treating hallux valgus. Yammine, K., Assi, C.[2020]

Citations

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pmc.ncbi.nlm.nih.gov

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Modified Chevron Osteotomy with Distal Soft Tissue ...

The modified Chevron osteotomy together with distal soft tissue release could achieve a satisfied result for moderate to severe HV deformity at early follow‐up.

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sciencedirect.com

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Distal Chevron Osteotomy with Lateral Soft Tissue Release ...

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Chevron Osteotomy With Lateral Soft Tissue Release

The chevron osteotomy is one of the most common techniques for the correction of hallux valgus deformity. Earlier reports have cautioned ...

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withpower.com

withpower.com/trial/phase-bunion-5-2021-4b233

Lateral Soft Tissue Release for Bunions

Research shows mixed results on the benefits of adding lateral soft tissue release to chevron osteotomy for bunion correction, with some studies noting ...

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josr-online.biomedcentral.com

josr-online.biomedcentral.com/articles/10.1186/s13018-022-02974-0

Distal chevron osteotomy versus different operative ...

Our findings indicate that distal chevron osteotomy provides a greater HVA correction than scarf osteotomy, and proximal chevron provides a larger IMA ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10192500/

Outcomes After Chevron Osteotomy with and Without ...

The chevron osteotomy group showed a significant increase in the mean HVA from 18.37° at the first follow-up visit to 20.81° at the last follow- ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S126877310400075X

Lateral release in hallux valgus surgery: comparison of two ...

The aim of this study was to evaluate the outcome of a combined distal chevron osteotomy and a lateral soft tissue release using a dorsal first web space ...

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Comparison of third-generation minimally invasive surgery,...

This study compared the efficacy of 3rd-MIS using split-drill osteotomy to that of TCO in treating mild to moderate HV with metatarsalgia in 52 middle-aged ...