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Active, not recruitingNCT06486753Updated Sep 8, 2026

LSTR in Chevron Osteotomy

An interventional study of Chevron osteotomy bunion surgery with lateral soft tissue release in Bunion, sponsored by The Methodist Hospital Research Institute. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by The Methodist Hospital Research Institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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).
02

Conditions studied

  • Bunion

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Over the age of 18 years old
  • Have mild to moderate bunions that are determined to benefit from Chevron osteotomies

Exclusion criteria

Exclusion Criteria:

  • Under the age of 18
  • Connective tissue disease
  • Juvenile bunions
  • Severe bunions
  • Revision surgery
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • 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.

    Procedure: Chevron osteotomy bunion surgery with lateral soft tissue release

Interventions

  • ProcedureChevron osteotomy bunion surgery with lateral soft tissue release

    Lateral soft tissue release is often performed in hallux valgus correction, and there is preliminary evidence to suggest it may be useful in improving post-surgical outcomes for the Chevron osteotomy bunion surgery.

05

What researchers measure

Primary outcomes

  1. Hallux valgus alpha angle correction

    Time frame: Pre-surgery, 6 weeks post surgery

Secondary outcomes

  1. Intermetasarsal angle (IMA) degrees of correction

    Time frame: 3 months, 6 months, and 12 months post surgery

  2. Recurrence of hallux valgus deformity

    Time frame: 3 months, 6 months, and 12 months post surgery

  3. Complications following surgery

    We will be looking at complications including possible metatarsal head avascular necrosis (AVN) and over correction (hallux varus).

    Time frame: 3 months, 6 months, and 12 months post surgery

06

Study locations

1 site
  • Houston Methodist Research Institute
    Houston, Texas 77030, United States
07

Registry details

Key details

Study ID
NCT06486753
Lead sponsor
The Methodist Hospital Research Institute
Responsible party
Kevin Varner (Chairman of the Department of Orthopedics, The Methodist Hospital Research Institute) — Principal investigator
First posted
Jul 3, 2024
Start date
Jun 24, 2021
Primary completion
Mar 9, 2027 (estimated)
Completion
Dec 9, 2028 (estimated)
Last update
Sep 8, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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