Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06486753

LSTR in Chevron Osteotomy

Led by The Methodist Hospital Research Institute · Updated on 2024-07-03

200

Participants Needed

1

Research Sites

350 weeks

Total Duration

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AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

LSTR in Chevron Osteotomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Over the age of 18 years old
  • Have mild to moderate bunions that are determined to benefit from Chevron osteotomies
Not Eligible

You will not qualify if you...

  • Under the age of 18
  • Connective tissue disease
  • Juvenile bunions
  • Severe bunions
  • Revision surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Houston Methodist Research Institute

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

H

Haley M Goble, MHA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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