Bunion
Conditions
Brief summary
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).
Interventions
PROCEDUREChevron osteotomy bunion surgery with lateral soft tissue release
Lateral soft tissue release is often performed in hallux valgus correction, and there is preliminary evidence to suggest it may be useful in improving post-surgical outcomes for the Chevron osteotomy bunion surgery.
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hallux valgus alpha angle correction | Pre-surgery, 6 weeks post surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intermetasarsal angle (IMA) degrees of correction | 3 months, 6 months, and 12 months post surgery | — |
| Recurrence of hallux valgus deformity | 3 months, 6 months, and 12 months post surgery | — |
| Complications following surgery | 3 months, 6 months, and 12 months post surgery | We will be looking at complications including possible metatarsal head avascular necrosis (AVN) and over correction (hallux varus). |
Countries
United States
Outcome results
None listed