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Effect of Lateral Soft Tissue Release on Patient-Reported Outcomes and Hallux Valgus Angle Correction in Chevron Osteotomy
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Houston Methodist Research Institute
Houston, Texas, United States
Start Date
June 24, 2021
Primary Completion Date
March 9, 2026
Completion Date
March 9, 2028
Last Updated
July 3, 2024
200
ESTIMATED participants
Chevron osteotomy bunion surgery with lateral soft tissue release
PROCEDURE
Lead Sponsor
The Methodist Hospital Research Institute
NCT04713098
NCT05773846
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05087914