LSTR in Chevron Osteotomy

NCT06486753 | Recruiting

• 1 other identifier: PRO00026261
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Bunion

Outcome Measures

Primary Outcomes (1)

• Hallux valgus alpha angle correction

  Pre-surgery, 6 weeks post surgery

Secondary Outcomes (3)

• 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

  3 months, 6 months, and 12 months post surgery

Study Arms (2)

Chevron osteotomy bunion surgery without LSTR

NO INTERVENTION

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

Chevron osteotomy bunion surgery with LSTR

EXPERIMENTAL

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

Chevron osteotomy bunion surgery with lateral soft tissue release PROCEDURE

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.

Chevron osteotomy bunion surgery with LSTR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Research Institute

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Bunion

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases

Central Study Contacts

Haley M Goble, MHA

CONTACT

713-441-3930; hmgoble@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of the Department of Orthopedics

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 3, 2024
• Study Start: June 24, 2021
• Primary Completion: March 9, 2026
• Study Completion (Estimated): March 9, 2028
• Last Updated: July 3, 2024

Record last verified: 2024-06

Locations

US (1)