Evaluating the impact of lateral soft tissue release during bunion surgery
Effect of Lateral Soft Tissue Release on Patient-Reported Outcomes and Hallux Valgus Angle Correction in Chevron Osteotomy
This study is testing if adding a soft tissue release to bunion surgery helps people with mild to moderate bunions feel better after their operation without causing more problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Methodist Hospital Research Institute Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06486753 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess whether adding a lateral soft tissue release (LSTR) to a Chevron osteotomy for bunions improves surgical outcomes without increasing complications. The study will involve 200 patients over the age of 18 with mild to moderate bunions who are eligible for Chevron osteotomies. Participants will be randomly assigned to receive either the standard Chevron osteotomy or the procedure with LSTR, and the researchers will measure the correction of the hallux valgus alpha angle and intermetatarsal angle. The goal is to determine if the addition of LSTR leads to better correction of bunions.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with mild to moderate bunions suitable for Chevron osteotomy.
Not a fit: Patients with severe bunions, juvenile bunions, or those requiring revision surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes for patients undergoing bunion correction.
How similar studies have performed: While similar approaches have been explored, this specific combination of LSTR with Chevron osteotomy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Over the age of 18 years old * Have mild to moderate bunions that are determined to benefit from Chevron osteotomies Exclusion Criteria: * Under the age of 18 * Connective tissue disease * Juvenile bunions * Severe bunions * Revision surgery
Where this trial is running
Houston, Texas
- Houston Methodist Research Institute — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Haley M Goble, MHA
- Email: hmgoble@houstonmethodist.org
- Phone: 713-441-3930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.