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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

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

ArmDescriptionAssigned 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.
  • 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.

Recruiting Locations

Houston Methodist Research Institute
Houston, Texas 77030
Contact:
Haley M Goble, MHA
713-441-3930
hmgoble@houstonmethodist.org

More Details

Status
Recruiting
Sponsor
The Methodist Hospital Research Institute

Study Contact

Haley M Goble, MHA
713-441-3930
hmgoble@houstonmethodist.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.