LSTR in Chevron Osteotomy

The Methodist Hospital Research Institute (TMHRI)

Status: Enrolling

Conditions: Bunion

Treatments: Procedure: Chevron osteotomy bunion surgery with lateral soft tissue release

Study type: Interventional

Funder types: Other

Identifiers

NCT06486753

PRO00026261

Details and patient eligibility

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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Chevron osteotomy bunion surgery without LSTR

No Intervention group

Description:

Participants randomized to this group will receive a standard Chevron osteotomy bunion surgery.

Chevron osteotomy bunion surgery with LSTR

Experimental group

Description:

Participants randomized to this group will receive a Chevron osteotomy bunion surgery and a lateral soft tissue release.

Treatment:

Procedure: Chevron osteotomy bunion surgery with lateral soft tissue release