LSTR in Chevron Osteotomy
Purpose
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).
Condition
- Bunion
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention Chevron osteotomy bunion surgery without LSTR |
Participants randomized to this group will receive a standard Chevron osteotomy bunion surgery. |
|
|
Experimental Chevron osteotomy bunion surgery with LSTR |
Participants randomized to this group will receive a Chevron osteotomy bunion surgery and a lateral soft tissue release. |
|
Recruiting Locations
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- The Methodist Hospital Research Institute