LSTR in Chevron Osteotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chevron osteotomy bunion surgery with lateral soft tissue release.
- Who it may be relevant to
- Registry conditions: Bunion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Lateral Soft Tissue Release on Patient-Reported Outcomes and Hallux Valgus Angle Correction in Chevron Osteotomy
Overview
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
- Procedure Chevron 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.
Primary outcome measures
- Hallux valgus alpha angle correction [Time frame: Pre-surgery, 6 weeks post surgery]
Secondary outcome measures (3)
- Intermetasarsal angle (IMA) degrees of correction [Time frame: 3 months, 6 months, and 12 months post surgery]
- Recurrence of hallux valgus deformity [Time frame: 3 months, 6 months, and 12 months post surgery]
- Complications following surgery [Time frame: 3 months, 6 months, and 12 months post surgery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Houston Methodist Research Institute — Houston
Identifiers
NCT: NCT06486753 · PRO00026261