LSTR in Chevron Osteotomy

Conditions

• Bunion

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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).

Key Dates

Start date

Jun 24, 2021

Status verified

Jun 2024

Primary completion

Mar 9, 2026

Completion

Mar 9, 2028

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

Hallux valgus alpha angle correction [ Time Frame: Pre-surgery, 6 weeks post surgery ]

Central Contacts

• Haley M Goble, MHA
  713-441-3930
  [email protected]

Locations (1)

Find similar trials in Houston, TX

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