Effect of Lateral Soft Tissue Release on Patient-Reported Outcomes and Hallux Valgus Angle Correction in Chevron Osteotomy

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Over the age of 18 years old

• Have mild to moderate bunions that are determined to benefit from Chevron osteotomies

Locations
United States
Texas
Houston Methodist Research Institute
RECRUITING
Houston
Contact Information
Primary
Haley M Goble, MHA
hmgoble@houstonmethodist.org
713-441-3930
Time Frame
Start Date: 2021-06-24
Estimated Completion Date: 2028-03-09
Participants
Target number of participants: 200
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: The Methodist Hospital Research Institute

This content was sourced from clinicaltrials.gov

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