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

Trial Summary

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 data supports the effectiveness of the treatment Chevron Osteotomy with 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 complications. However, it is often used to improve the correction of the bunion deformity during surgery. ^{1 2 3 4 5}

Is lateral soft tissue release for bunion surgery safe?

Lateral soft tissue release, often used in bunion surgery, has been associated with various complications. While it is commonly performed with a type of bone surgery called distal chevron osteotomy, the safety and necessity of this additional procedure are still debated among experts. ^{1 2 3 6 7}

What makes the treatment Chevron Osteotomy with Lateral Soft Tissue Release unique for bunion correction?

This treatment is unique because it combines a bone-cutting procedure (Chevron Osteotomy) with a technique to release tight tissues on the side of the foot (Lateral Soft Tissue Release), which can be particularly effective for moderate to severe bunions when the joint is flexible enough. This combination can provide better correction of the deformity compared to the bone-cutting procedure alone. ^{2 3 4 5 8}

What is the purpose of this trial?

The goal of this clinical trial is to determine if performing a lateral soft tissue release during a Chevron osteotomy (or Akin osteotomy when appropriate) for bunions leads to better correction without added complications in 200 patients over the age of 18 years old with the capacity to consent and mild to moderate bunions that are determined to benefit from Chevron osteotomies by one of the IRB approved study physicians. The main questions it aims to answer are: How does the addition of a lateral soft tissue release (LSTR) in a Chevron osteotomy bunion surgery affect hallux valgus alpha angle (HVA) correction? How does the addition of an LSTR in a Chevron osteotomy bunion surgery affect intermetatarsal angle (IMA) degrees of correction? Researchers will compare Chevron osteotomy bunion surgeries with and without LSTR to see if LSTRs lead to better correction without added complications. Participants will: * Be randomized to a control group where they receive a typical Chevron osteotomy bunion surgery or to the experimental group where they receive a Chevron osteotomy bunion surgery with an LSTR. * Complete surveys preoperatively and at 3, 6, and 12 months after surgery. * Receive routine x-rays pre and postoperatively to compare hallux valgus angle (HVA).

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Comparison of open lateral release and transarticular lateral release in distal chevron metatarsal osteotomy for hallux valgus correction. [2021]

2. France 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. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of distal chevron osteotomy with and without lateral soft tissue release for the treatment of hallux valgus. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Role of intraoperative varus stress test for lateral soft tissue release during chevron bunion procedure. [2014]

5. China pubmed.ncbi.nlm.nih.gov

[Modified Chevron osteotomy combined distal soft tissue reconstruction to treat high-grade bunionette deformity]. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of Lateral Soft Tissue Release on Sesamoid Position in Hallux Valgus Surgery. [2016]

7. United States 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. [2018]

8. United States 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. [2016]