LSTR in Chevron Osteotomy

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).

Study Overview

• Status: Recruiting
• Conditions: Bunion
• Intervention / Treatment: Procedure: Chevron osteotomy bunion surgery with lateral soft tissue release

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haley M Goble, MHA; Phone Number: 713-441-3930; Email: hmgoble@houstonmethodist.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Research Institute
      • Contact: Haley M Goble, MHA; Phone Number: 713-441-3930; Email: hmgoble@houstonmethodist.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hallux valgus alpha angle correction	Pre-surgery, 6 weeks post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intermetasarsal angle (IMA) degrees of correction		3 months, 6 months, and 12 months post surgery
Recurrence of hallux valgus deformity		3 months, 6 months, and 12 months post surgery
Complications following surgery	We will be looking at complications including possible metatarsal head avascular necrosis (AVN) and over correction (hallux varus).	3 months, 6 months, and 12 months post surgery

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2021
• Primary Completion (Estimated): March 9, 2026
• Study Completion (Estimated): March 9, 2028

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Bunion
• Other Study ID Numbers: PRO00026261

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No