LSTR in Chevron Osteotomy

Last updated: June 27, 2024
Sponsor: The Methodist Hospital Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bunion

Treatment

Chevron osteotomy bunion surgery with lateral soft tissue release

Clinical Study ID

NCT06486753
PRO00026261
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Over the age of 18 years old

  • Have mild to moderate bunions that are determined to benefit from Chevronosteotomies

Exclusion

Exclusion Criteria:

  • Under the age of 18

  • Connective tissue disease

  • Juvenile bunions

  • Severe bunions

  • Revision surgery

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Chevron osteotomy bunion surgery with lateral soft tissue release
Phase:
Study Start date:
June 24, 2021
Estimated Completion Date:
March 09, 2028

Connect with a study center

  • Houston Methodist Research Institute

    Houston, Texas 77030
    United States

    Active - Recruiting

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