LSTR in Chevron Osteotomy
- Conditions
- Bunion
- Interventions
- Procedure: Chevron osteotomy bunion surgery with lateral soft tissue release
- Registration Number
- NCT06486753
- Lead Sponsor
- The Methodist Hospital Research Institute
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Over the age of 18 years old
- Have mild to moderate bunions that are determined to benefit from Chevron osteotomies
- Under the age of 18
- Connective tissue disease
- Juvenile bunions
- Severe bunions
- Revision surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chevron osteotomy bunion surgery with LSTR Chevron osteotomy bunion surgery with lateral soft tissue release Participants randomized to this group will receive a Chevron osteotomy bunion surgery and a lateral soft tissue release.
- Primary Outcome Measures
Name Time Method Hallux valgus alpha angle correction Pre-surgery, 6 weeks post surgery
- Secondary Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (1)
Houston Methodist Research Institute
🇺🇸Houston, Texas, United States